Proactiveinvestors USA & Canada Imugene Ltd https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Imugene Ltd RSS feed en Wed, 23 Jan 2019 03:42:14 -0500 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Imugene adds key members to its scientific advisory board to advance company forward ]]> https://www.proactiveinvestors.com/companies/stocktube/11802/imugene-adds-key-members-to-its-scientific-advisory-board-to-advance-company-forward-11802.html Fri, 11 Jan 2019 10:00:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11802/imugene-adds-key-members-to-its-scientific-advisory-board-to-advance-company-forward-11802.html <![CDATA[News - Imugene granted Canadian patent for proprietary cancer vaccine ]]> https://www.proactiveinvestors.com/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.html Imugene (ASX:IMU) has achieved a major milestone by securing a patent for its proprietary cancer vaccine, HER-Vaxx, from the Canadian Patent Office.

The company’s shares were last trading 13% higher intra-day, at A$0.017.

HER-Vaxx is a next generation cancer immunotherapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene is currently enrolling gastric cancer patients at eight key cancer hospital sites in Asia, including Hong Kong, Thailand and Taiwan.

HER-Vaxx works by targeting the same receptor (and additional receptors) as Herceptin and Perjeta, two of the leading antibody drugs on market, with annual sales of US$8.2 billion.

Current immunotherapies are predicted to generate sales of US$36 billion by 2025 but costs remain prohibitive for patients.

The mechanism of action for HER-Vaxx may help generate improved efficacy over existing treatments and at a lower cost.

Gastric cancer is a leading cause of cancer death worldwide, representing 10.1% of male cases, with the incidence of gastric cancer substantially higher in Asia.

Imugene had raised circa A$3 million as part of an option plan which expired on 31 March 2017, at a price of A$0.015 per share.

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Fri, 21 Jul 2017 13:00:00 -0400 https://www.proactiveinvestors.com/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.html
<![CDATA[News - Imugene Ltd gets site approval for gastric cancer study in Thailand ]]> https://www.proactiveinvestors.com/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.html Imugene Ltd (ASX:IMU) has received approval from the Faculty of Medicine, Chiang Mai University of Thailand to start site activation process for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval in Thailand follows approvals from Taipei Veterans General Hospital in Taiwan and the University of Hong Kong.

Thailand, Taiwan and Hong Kong and are three of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asian countries.

Imugene had $1.6 million in cash as at 30 June 2016.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Mon, 22 Aug 2016 13:30:00 -0400 https://www.proactiveinvestors.com/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.html
<![CDATA[News - Imugene Ltd to start gastric cancer treatment studies in Taiwan ]]> https://www.proactiveinvestors.com/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.html Imugene Ltd (ASX:IMU) has received approval from the Institutional Review Board of the Taipei Veterans General Hospital in Taiwan for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Rather than attacking the cancer directly, as chemo does, immunotherapy tries to rally the patient’s own immune system to fight the disease.

The approval in Taiwan follows the University of Hong Kong Institutional Review Board Approval in July.

Hong Kong and Taiwan are two of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asia.

Imugene held $1.6 million in cash as at 30 June 2016.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 11 Aug 2016 12:30:00 -0400 https://www.proactiveinvestors.com/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.html
<![CDATA[News - Imugene Ltd gains approval for gastric cancer study in Hong Kong ]]> https://www.proactiveinvestors.com/companies/news/156526/imugene-ltd-gains-approval-for-gastric-cancer-study-in-hong-kong-69717.html Imugene Ltd (ASX:IMU) has received approval from the University of Hong Kong Institutional Review Board for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy for gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval from the Ethics Committee positions Imugene to enrol patients for the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

For Hong Kong there were around 1,100 new gastric cancer cases last year, representing a market for any product that is commercialised from the studies.

Imugene held $2.4 million in cash as at 31 March 2016.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 11 Jul 2016 12:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156526/imugene-ltd-gains-approval-for-gastric-cancer-study-in-hong-kong-69717.html
<![CDATA[News - Imugene initiates pan-Asia trial of gastric cancer treatment therapy ]]> https://www.proactiveinvestors.com/companies/news/156525/imugene-initiates-pan-asia-trial-of-gastric-cancer-treatment-therapy-68218.html Imugene Ltd (ASX:IMU), a clinical stage immuno-oncology company, has initiated a pan-Asia trial of the company’s HER-Vaxx therapy for gastric cancer patients by making a regulatory package submission for the Phase 1b/2 study in Hong Kong.

This filing represents the first submission to various regulators across Asia to initiate clinical testing of Imugene’s HER-Vaxx therapy, given the high unmet need in this area for patients who have HER-2 positive gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

In conjunction with Novotech, Imugene’s contract research organisation for the study, the company has filed to initiate the study with the Department of Health of Hong Kong.

The proposed HER-Vaxx Phase 1b/2 study will be conducted in two parts.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Imugene has identified eight study sites in Asia to participate in the Phase 1b part of the study. Regulatory filings in other jurisdictions will be done in the next two months.

The principal investigator for Imugene’s Hong Kong site will be Dr Thomas Yau, one of Hong Kong’s leading medical oncologists, whose main research priority is gastrointestinal oncology.

 

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Thu, 21 Apr 2016 16:00:00 -0400 https://www.proactiveinvestors.com/companies/news/156525/imugene-initiates-pan-asia-trial-of-gastric-cancer-treatment-therapy-68218.html
<![CDATA[News - Imugene rings in changes as gastric cancer trial preparation picks up pace ]]> https://www.proactiveinvestors.com/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.html Imugene (ASX:IMU) has added Dr. Anton Uvarov to its Board as a non executive director as the immuno-oncology company picks up the pace of work for its gastric cancer study in 2016.

Dr Uvarov worked for two years in the U.S. healthcare research team at Citigroup Global Markets covering small and mid-cap biotechnology companies and holds a PhD degree in Biochemistry and Medical Genetics.

Stuart Roberts was appointed Head of Corporate Development this week. Previously he worked at Prima BioMed (ASX:PRR).

Imugene is a clinical stage immuno-oncology company with a lead product, HER-Vaxx a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene's unique immunotherapy has been shown in pre-clinical work and in one Phase 1 study to stimulate a potent polyclonal antibody response to HER-2/neu, a known and validated cancer target.

HER-Vaxx’s successful Phase 1 study was in patients with breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer.

Novotech was recently appointed as the lead contract researcher for the upcoming Phase 1b/2 trial of HER-Vaxx in gastric cancer.

The trial design was largely completed with a focus on Asia. Start up activity for the HER-Vaxx Phase 1b/2 study in gastric cancer is underway and clinical commencement is expected in the first half of 2016.

Under Novotech, Imugene’s investigators will recruit patients with HER-2 positive gastric cancer at a number of leading cancer centres in Asia.

The study will be conducted in two parts. The initial Phase 1b will be an open-label dose escalation study designed to evaluate the safety as well as the pharmacokinetics of HER-Vaxx. This will also determine optimal dosage.

A larger Phase 2 study will be a randomised controlled study of HER-Vaxx plus standard of care against standard of care alone.




Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

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Tue, 05 Jan 2016 11:42:00 -0500 https://www.proactiveinvestors.com/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.html
<![CDATA[News - Imugene cashes up ahead of hotly anticipated cancer treatment trials ]]> https://www.proactiveinvestors.com/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.html Imugene Limited (ASX:IMU) has further underscored investor confidence in its HER-Vaxx product with about A$756,000 in new government funding as trials for the cancer therapy approach.

The tax refund comes as part of the Australian government’s research and development incentive program, which is aimed at converting innovative research into tangible, market-ready outcomes.

These funds complement Imugene’s $3 million capital raising announced in September and will contribute to the progression of HER-Vaxx, which is due to enter additional human Phase Ib/II gastric cancer clinical trials in 2016.

Imugene chief operating officer Leslie Chong commented:

“This is valuable non-dilutive capital for Imugene. If we succeed in commercialising HER-Vaxx, it will mean a potential Australian blockbuster drug and a better treatment for people who suffer HER2-positive gastric, breast and other cancers.”

Trials of Imugene HER-Vaxx therapy for gastric cancer are expected to demonstrate the medical and commercial viability of the company’s strategy as investors contemplate a multi-decade rollout of patenting and royalties related to a strong intellectual property portfolio.

Imugene IP is exclusive until 2030 and granted in all major jurisdictions. The company, however, is now aiming for an extension of these rights until 2036.

The macro context for this marketing scheme is underpinned by the prevalence and high death rate of gastric cancer, particularly in Japan, Korea and China.


Hot field

The use of immunotherapy to develop vaccines against gastric and breast cancers is considered the hottest area of oncology today thanks to the breakthrough approval last year of the first cancer cell-killing drug for blockading immune checkpoints.

Immune checkpoints are molecules within the immune system which have emerged as increasingly researched targets for treating cancer.

HER-Vaxx trials will explore Imugene’s vaccine on breast cancer by targeting HER-2 receptors on cancer cells. This is a clinically and commercially validated cancer target. The killing of HER-2 receptors results in the host cancer cells stopping growth and dying.

The trial work could improve Imugene’s chances of acquiring orphan drug designation from the U.S. Food and Drug Administration as well as steering development of follow-up clinical candidates using HER-Vaxx technology.


Sharpening profile

In addition to the $3 million share placement last month, the latest R&D refund and the imminent HER-Vaxx trialling, Imugene has bolstered its investment case with the recent appointment of Chong in the role of chief operating officer.

An immune-oncology specialist, Chong served previously as senior clinical program lead at Genetech Inc in the U.S., which is widely regarded as one of the world’s most successful biotech companies with a significant oncology franchise including the best-selling breast cancer drug, Herceptin.

Her deep immuno-oncology experience and industry networks are expected to be invaluable as HER-Vaxx development milestones come into focus.


Analysis

The latest investment has continued to demonstrate the attractiveness of Imugene’s product pipeline, which includes a trial-ready drug targeting the same receptor as the A$6.4 billion breast cancer drug, Herceptin.

This investor enthusiasm also indicates that the upcoming gastric cancer human clinical trials for HER-Vaxx represent a significant share price catalyst next year for this lightly valued $16 million-capped stock.

Imugene's validated HER-2 target and a world-class drug development team in Dr Axel Hoos and Professor Ursula Weidermann provide investors with a credentialed pure-play listed immuno-oncology stock – once the preserve of “big pharma”.

Beyond its HER-Vaxx product holdings, Imugene also owns a drug delivery platform, Linguet, which uses its proprietary technology to improve the efficacy and safety of a diverse number of existing prescription and over-the-counter medicines.

Further product diversification can be found in Imugene’s development of a vitamin D supplement tablet, which melts in the mouth, better known as a “meltlet”. The technology is available for outlicensing to interested parties.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 28 Oct 2015 14:53:00 -0400 https://www.proactiveinvestors.com/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.html
<![CDATA[News - Imugene raises $3M to start gastric cancer clinical trial ]]> https://www.proactiveinvestors.com/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.html Imugene (ASX:IMU) has received firm commitments to raise $3 million through a placement of shares priced at $0.0075 each to sophisticated investors.

This includes one free attaching option exercisable at $0.015 and expiring on 31st March 2017 for every two shares subscribed.

The company also plans to issue 2 bonus options for every 15 shares held in the company to shareholders. These have the same terms as the placement options.

The capital raising includes a subscription by non-executive director Otto Buttula for shares amounting to $225,000 and non-executive director Charles Walker for $11,250 worth of shares.

Proceeds will be used to initiate the company’s Phase 1b/2 clinical trial for its HER-Vaxx gastric cancer treatment and additional preclinical work on HER-Vaxx drug combinations.
   
The company has already appointed global contract research organisation (CRO) Simbec-Orion to conduct the trial and is targeting late this year or early 2016 to commence the Phase 1b trial.

Shareholder approval will be sought at company’s upcoming annual general meeting for the share placement.

Paul Hopper, executive chairman, commented:

“We are delighted to welcome new and existing shareholders to Imugene in this placement. The funds raised from this placement, subject to shareholder approval, in addition to our existing cash position, places us in a strong position to move ahead with our program.

“With our newly appointed COO, Ms. Leslie Chong, commencing her role shortly and the start of clinical trials, we look forward to an exciting time ahead for Imugene.”


Recent Activity

Imugene is in the later stages of planning to conduct a new preclinical study of HER-Vaxx in an additional disease model of gastric cancer.

This could improve the company’s case to achieve orphan drug designation from the United States Food and Drug Administration as well as steering development of follow up clinical candidates using the HER-Vaxx technology.

Chief Scientific Officer Professor Ursula Wiedermann is also conducting additional work at the Medical University of Vienna on the final chosen formulation of HER-Vaxx.

This work is looking to further establish additional evidence of the enhanced efficacy from the new formulation of HER-Vaxx.


HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.


Analysis

The $3 million to be raised will allow Imugene to start the HER-Vaxx gastric cancer human clinical trial, which is a key inflection point.

Pre-clinical data had previously showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 08 Sep 2015 12:17:00 -0400 https://www.proactiveinvestors.com/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.html
<![CDATA[News - Imugene Limited on road to raising ]]> https://www.proactiveinvestors.com/companies/news/156520/imugene-limited-on-road-to-raising-64387.html Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) has been granted a trading halt by the ASX, with its shares placed in pre-open.

Imugene is currently preparing to release capital raising details.

The company is developing HER-2+ gastric and breast cancer immunotherapies.

The halt will remain in place until the opening of trade on Wednesday 9th September 2015, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 07 Sep 2015 16:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156520/imugene-limited-on-road-to-raising-64387.html
<![CDATA[News - Imugene Limited appoints Leslie Chong as chief operating officer ]]> https://www.proactiveinvestors.com/companies/news/156519/imugene-limited-appoints-leslie-chong-as-chief-operating-officer-64236.html Imugene Limited (ASX:IMU) has appointed Leslie Chong as its chief operating officer with effect from mid-September.

She was most recently a senior clinical program leader at San Francisco-based Genentech, Inc, a global leader in immuno-oncology and developer of Herceptin before it was acquired by Roche in 2009 for US$46.8 billion.

Paul Hopper, executive chairman, commented:

“We are delighted that someone of Leslie’s calibre, deep immuno-oncology experience, industry networks, and from one of the world’s most successful and prestigious drug developers, has agreed to join our team.

“IMU is at an important stage of its clinical development and Leslie’s deep, hands-on clinical trial experience across many studies will be invaluable to us.”

Separately, managing director Charles Walker will step down from his position and continue as a non-executive director of the company.

In July, the company selected global contract research organisation (CRO) Simbec-Orion to conduct the upcoming HER-Vaxx gastric cancer human clinical trial.
   
The Phase 1b/2 clinical study is on track to begin in the second half of 2015. Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 27 Aug 2015 16:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156519/imugene-limited-appoints-leslie-chong-as-chief-operating-officer-64236.html
<![CDATA[News - Imugene on track to start gastric cancer clinical trial in 2H 2015 ]]> https://www.proactiveinvestors.com/companies/news/156518/imugene-on-track-to-start-gastric-cancer-clinical-trial-in-2h-2015-63226.html Imugene (ASX:IMU) has hit a milestone with global contract research organisation (CRO) Simbec-Orion selected to conduct the upcoming HER-Vaxx gastric cancer human clinical trial.
   
The Phase 1b/2 clinical study is on track to begin in the second half of 2015.

Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Charles Walker, managing director, said:

“This is another milestone passed as the selection of specialist CRO Orion will greatly assist the company conduct a thorough and well prepared immuno-oncology clinical trial.

“Our trial is designed to be statistically robust and also yield early significant data. The trial has been designed to appeal to potential partners and help steer the Phase 3 clinical trial design.

“We look forward to working with our new partner and reporting on the inevitable progress.”

Ronald Openshaw, Simbec-Orion chief executive officer, added:

“We are pleased to prevail in Imugene’s stringent selection process and look forward to driving this important clinical trial.

“We will ensure a combination of rigour and efficiency and are adamant about achieving on timelines and quality of data that should satisfy the US FDA.”


HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

This study will be a key inflection point underpinned by many years of research.

In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

Manufacturing has also been simplified with increased reliability and lower cost.

Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.


Analysis

The appointment of global CRO Simbec-Orion to fast track plans and logistics for the upcoming HER-Vaxx gastric cancer human clinical trial is a key milestone for Imugene.

The upcoming Phase 1b/2 clinical study in the second half of 2015 is expected to be closely watched given the encouraging pre-clinical data.

Share Price Catalysts
- Grant of US FDA IND;
- Appoint Principal Investigator;
- Announce preclinical toxicology results;
- Recruit and run lead in Phase 1b trial 2H 2015;
- Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
- Report Phase 1 trial results 2H 2015 to 1H 2016; and
- Report Phase 2 results 2H 2017/1H 2018.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 01 Jul 2015 08:00:00 -0400 https://www.proactiveinvestors.com/companies/news/156518/imugene-on-track-to-start-gastric-cancer-clinical-trial-in-2h-2015-63226.html
<![CDATA[News - Imugene issuing 5 million options to non-executive director Dr Axel Hoos ]]> https://www.proactiveinvestors.com/companies/news/156517/imugene-issuing-5-million-options-to-non-executive-director-dr-axel-hoos-63187.html Imugene Limited (ASX:IMU) is issuing 5 million options to non-executive director Dr Axel Hoos as a cost effective incentive based form of remuneration.

This further aligns his interests and remuneration to the achievement of operational milestones, share price appreciation and improved shareholder value.

Dr Hoos is a highly qualified and internationally respected medical research professional who has played a key role in the development of Imugene's HER-2+ gastric and breast cancer therapies and his ongoing involvement and incentivisation is critical for Imugene as it focusses on delivering key milestones.

The issue of options is subject to shareholder approval and the following terms and conditions:

- 2.5 million options exercisable at $0.0125 per option and vest upon recruitment of first patient for Phase 1b trial;
- 2.5 million options are exercisable at $0.0175 per option and vest on recruitment of first patient for Phase 2 trial;
- Options expire 4 years from the date of issue; and
- Any options not vested will lapse if Dr. Hoos ceases to be a director of the company.


Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
   
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 29 Jun 2015 17:00:00 -0400 https://www.proactiveinvestors.com/companies/news/156517/imugene-issuing-5-million-options-to-non-executive-director-dr-axel-hoos-63187.html
<![CDATA[News - Imugene Limited appoints Dr Ursula Wiedermann as chief scientific officer ]]> https://www.proactiveinvestors.com/companies/news/156516/imugene-limited-appoints-dr-ursula-wiedermann-as-chief-scientific-officer-62767.html Imugene Limited (ASX:IMU) has appointed Medical University of Vienna Professor of Vaccinology Dr Ursula Wiedermann as its chief scientific officer.

Notably, she worked as the principal investigator for the preclinical development of the company’s HER-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer alongside Professor Christophe Zielinski.

Together they performed the Phase I Clinical trial of HER-Vaxx in metastatic breast cancer patients.

Wiedermann has a distinguished scientific career with a particular interest in immunology and vaccines with over 110 publications in peer reviewed scientific journals to her credit.

She currently serves on the company’s scientific advisory board.

“This is a real coup for Imugene and we are delighted to have a scientist of such international renown as Prof Dr Wiedermann formalise her position in the Company as CSO,” managing director Charles Walker said.

“Ursula is a founding inventor of HER-Vaxx and her resume reflects her extraordinary prowess as a scientist, physician and educator and confirms her status as one of the leading lights in immuno-oncology globally.

“The CSO appointment is part of our ongoing initiative to put in place a first class management team capable of realizing the very significant opportunity that is our HER-Vaxx technology.”

Wiedermann added:

“Since my first introduction to Imugene several years ago I have strongly supported the HER-Vaxx development strategy and believe both our interests are aligned in bringing this exciting cancer technology to market as soon as possible.

“As the coinventor of the science and my new closer role in the company we can surely develop HER-Vaxx in a shorter time-frame.”


Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.
   
This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 05 Jun 2015 13:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156516/imugene-limited-appoints-dr-ursula-wiedermann-as-chief-scientific-officer-62767.html
<![CDATA[News - Imugene files for new cancer vaccine patent ]]> https://www.proactiveinvestors.com/companies/news/68262/imugene-files-for-new-cancer-vaccine-patent-79532.html Imugene Limited (ASX:IMU) has filed a new patent for its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer that could extend patent life to 2036.

This protects new vaccine formulations designed to enhance the immune response obtained on administration of HER-Vaxx.

The new formulation had demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing and prompts a faster response from the immune systems, requiring just three vaccinations to achieve peak results.

It also has improved manufacturing making it cheaper, simpler and more reliable to make.

This new formulation will be used in the Phase 1b/2 trial that is on track to commence in the second half of 2015.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

“Maintaining and strengthening our already strong international intellectual property position is a key area of focus in maintaining the competitive advantage of HER-Vaxx and any future improvements, vaccine formulations and clinical uses,” managing director Charles Walker said.

“We are extremely pleased with the progress made from our expert scientific team.”   

“This new patent filing potentially protects HER-Vaxx until 2036 which would be significantly longer than the vast majority of competing clinical stage products and technologies.

“The additional patent life adds an additional six years to the time HER-Vaxx could remain generating peak sales, adding to the total amount of potential sales achievable by HER-Vaxx and hence significantly increasing the value of HER-Vaxx.”


Enhanced Formulation

The enhanced formulation of HER-Vaxx incorporates an existing, clinically and commercially validated vaccine carrier protein called CRM197 together with an adjuvant.

CRM197 replaces the virosomes used in previous formulations of HER-Vaxx.

The experiments indicate a potentially lower dose, and a fewer number of immunisations could be required for a better clinical outcome than with the previous virosome-based formulation of HER-Vaxx.

Of importance from a clinical perspective, based on the immunogenicity results against extracellular HER-2/neu, there was a clear difference in the kinetics of antibody responses in the course of immunisations.

This showed that the reformulated HER-Vaxx leads to earlier antibody increases (significant after 2 immunisations, with a peak response observed after 3 immunisations), compared with the earlier virosome-based formulation of HER-Vaxx.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 21 Apr 2015 13:00:00 -0400 https://www.proactiveinvestors.com/companies/news/68262/imugene-files-for-new-cancer-vaccine-patent-79532.html
<![CDATA[News - Imugene Limited sees large increase in cancer fighting antibodies ]]> https://www.proactiveinvestors.com/companies/news/68213/imugene-limited-sees-large-increase-in-cancer-fighting-antibodies--79477.html Imugene Limited's (ASX:IMU) new formulation of its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer has demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

The results show a convincing improvement in the immune system’s response to HER-Vaxx.

It also has improved manufacturing making it cheaper, simpler and more reliable to make.

The results will be used in the Phase 1b/2 trial that is on track to commence in the second half of 2015.
   
Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

The work has been conducted by the research team at the Medical University of Vienna under the direction of Professor Dr Ursula Wiedermann, principal investigator for the preclinical development of HER-Vaxx, and member of the Imugene Scientific Advisory Board.

Further, the company has filed new patent applications around the new formulation for major jurisdictions. When granted, these would reset Imugene’s intellectual property ownership to 2036 from the current expiry of 2030 and also extend geographical coverage.

“The re-formulation represents not only the achievement of another milestone, but also a very significant technical improvement given the greatly improved cancer-fighting antibody production and, as important, the significantly improved response time based on animal model testing,” managing director Charles Walker said.

“The kinetics, or speed of response, has been a reason why some vaccines have failed in the past and it is greatly encouraging to see this element addressed.

“We will utilize this formulation in the Phase 1b/2 trial in HER-2 positive gastric cancer that is on track to commence in the second half of 2015.

“As a result of this significant advance, we have further de-risked the asset given the lower cost, simpler manufacturing process and potentially extended the patent life based on recently filed applications. I commend the significant efforts of our scientific team in Vienna and in Australia.”

Professor Wiedermann added: “It is pleasing to see a simple formulation change optimise HER-Vaxx, which we know to have great potential.

“The early onset of response is important to any cancer vaccine and to see this alongside higher antibody titers is very exciting.”


Enhanced Formulation

The enhanced formulation of HER-Vaxx incorporates an existing, clinically and commercially validated vaccine carrier protein called CRM197 together with an adjuvant.

CRM197 replaces the virosomes used in previous formulations of HER-Vaxx.

The experiments indicate a potentially lower dose, and a fewer number of immunisations could be required for a better clinical outcome than with the previous virosome-based formulation of HER-Vaxx.

Of importance from a clinical perspective, based on the immunogenicity results against extracellular HER-2/neu, there was a clear difference in the kinetics of antibody responses in the course of immunisations.

This showed that the reformulated HER-Vaxx leads to earlier antibody increases (significant after 2 immunisations, with a peak response observed after 3 immunisations), compared with the earlier virosome-based formulation of HER-Vaxx.


HER-Vaxx

HER-Vaxx is a proprietary peptide vaccine or immunotherapy that causes the immune system to generate cancer-fighting antibodies.

It achieves this by stimulating a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.4 billion per annum drug Herceptin.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase 1b/2 trial in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered.  This will include 18 patients divided into 3 groups of 6.

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks.

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy.

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.


Immuno-oncology

Immuno-oncology is an emerging therapeutic approach that is being studied for its potential in the fight against cancer and focuses on an understanding of how cancer evades the immune system of a patient.

This approach is different from ways of treating cancer because it uses the natural capability of the patient’s own immune system to fight the cancer.

Imugene’s technology is being developed to stimulate a patient’s immune system to produce its own antibodies to a known and validated target for cancer which is the HER-2 receptor that is expressed on various tumors that include gastric, breast, ovarian, lung, and pancreatic cancers

Roche Holdings Ltd (US$251.1 billion valuation) owns Herceptin which is an antibody that targets the HER-2 receptor in breast and gastric cancer and reported annualised sales of $6.9 billion. Roche’s newly launched Perjeta also targets the HER-2 receptor.


Gastric Cancer opportunity

Gastric cancer is the second leading cause of cancer mortality globally and its management, especially in advanced stages, has evolved relatively little.

About 20% of patients with metastatic gastric cancer are HER-2 positive.

Surgery, chemotherapy, radiation and Herceptin are the key treatments.   

In many countries, particularly Asia, chemotherapy such as capecitibine and 5-FU, is the standard of care, not Herceptin.

Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year.

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year.

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.


Analysis

The results are highly significant and a boost as Imugene looks to progress clinical trials.

The improved formulation of Her-Vaxx has a notably faster – significant after 2 vaccinations with a peak at 3 vaccinations – and stronger (up to 10 times) antibody response, improving the chance of successful trials.

Imugene is also on track to commence clinical trials in the second half of 2015.

Other benefits include potentially extending patent life to 2036 from 2030, which represents more years at peak sales, as well as simpler and lower cost in manufacturing with reduced risks.

The latter makes more efficient use of cash reserves and could increase margins when on market.

This key milestone in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines in sight, has the potential to lift valuation this year.

With the potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker, the upside is significant for Imugene.

Proactive Investors can see further share price gains in 2015 given the current results and strong pipeline ahead. Our share price target was previously $0.034 - $0.047.

Share Price Catalysts

- Appoint CRO to run trial 1H 2015;
- US FDA IND granted 1H 2015;
- Appoint Principal Investigator 1H 2015;
- Announce preclinical toxicology results 1H 2015;
- Recruit and run lead in Phase 1b trial 2H 2015;
- Recruit and run double-blind randomized placebo controlled Phase 2 trial 2H 2015;
- Report Phase 1 trial results 2H 2015 to 1H 2016; and
- Report Phase 2 results 2H 2017/1H 2018.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 20 Apr 2015 10:30:00 -0400 https://www.proactiveinvestors.com/companies/news/68213/imugene-limited-sees-large-increase-in-cancer-fighting-antibodies--79477.html
<![CDATA[News - Cancer Vaccines: Immunotherapy’s New Wave ]]> https://www.proactiveinvestors.com/companies/news/68161/cancer-vaccines-immunotherapys-new-wave-79420.html Author: Global Health and Travel: Corey Cooper and Gabriele Bettinazzi.

Last August, doctors at the National Cancer Centre Singapore (NCCS) announced the launch of a US FDA-approved in-human clinical trial for an immune system-based cancer therapy known as a therapeutic cancer vaccine, one of the first such trials of its kind to be conducted in Asia.

For the Phase I trial, NCCS and the Singapore Clinical Research Institute (SCRI) are collaborating with a US-based biotech MicroVAX to test the effectiveness of the cancer vaccine in patients with breast, ovarian, prostate, colon and lung cancer – cancers that are extremely prominent in Western countries as well as East Asia.

The science behind cancer vaccines’ proposed therapeutic effect lies in vaccines’ ability to trigger the body’s immune system to produce antibodies that attack a very specific protein found on the surface of cancer cells, but not found in healthy cells.

In the case of MicroVAX’s vaccine, the vaccine targets the protein MUC-1, found in certain types of colon cancer, breast cancer, and others.

Once delivered into the body, the vaccine stimulates the immune system to produce antibodies that attach themselves to the MUC-1 protein, enabling the body to attack and kill the tumour cells.

The trial will continue through most of this year, and results will be known after an additional year of patient follow-up, says Dr. Toh Han Chong, NCCS Principal Investigator of the Phase I clinical trial, who is also deputy director at NCCS.

The MicroVAX vaccine is first being tested in patients with advanced stage cancer to prove its effectiveness versus conventional cancer therapies like chemotherapy.

“MicroVAX is of the vision that immunotherapy will be key for cancer therapy going forward. We believe that cancer vaccines will play a major role in this vision,” Jacob Frank, a spokesperson for MicroVAX, told Global Health and Travel.


Cancer vaccines emerge as a growing segment of immunotherapy research

The pioneer of immunotherapy can be traced back to the 1890s. William Coley, a New York-based surgeon, observed that infections hitting cancer patients were occasionally associated with the remission of the tumour.

On these empirical grounds, he started to treat cancer with streptococcal bacteria in order to further investigate the connection. In this way, he managed to stop the progression of the tumour in a few cases.

Immunotherapy emerged as a major research area of oncology in the 1990s, when US scientists discovered that the immune systems in mice could be “engaged” in order to fight cancer cells.

Since 2013, when Science magazine declared immunotherapy to be its “Breakthrough of the Year”, the development of immunotherapy drugs and funding for new research has skyrocketed.

Credit Suisse predicted that two immunotherapy drugs developed by Bristol-Myers Squibb, Yervoy (Ipilimumab) and Opvido (Nivolumab), both used to treat metastatic melanoma, could generate US$8.5 billion in annual revenue by 2020, according to The Wall Street Journal.

Speaking on immunotherapy as a whole, Dr. Kee Chee Soo, director of National Cancer Centre Singapore, called it “the new wave in cancer treatment” that will lead to sustained improvements in survival for patients who do not respond to conventional cancer therapies.

“There are many forms of immunotherapy, including Keytruda from Merck, that have prolonged patient’s lives,” Dr. Soo told Global Health and Travel.

“When you look at the survival curves, they are plateauing, suggesting that it’s not just a statistical survival advantage, but an actual survival advantage.”

In the past few years, cancer vaccines have emerged as a hot area for investment, with major drug developers like Johnson & Johnson and Roche signing multimillion-dollar deals with biotech companies to develop cancer vaccines.

A July 2014 report on Sfgate.com, citing industry analysts at Citi, predicted that cancer vaccines and other “emerging immunotherapies” would be US$35 billion market by 2023.

In June of last year, Johnson & Johnson invested US$55 million in the privately-held biotech Aduro, which is developing a cancer vaccine technology for prostate cancer.

A report from xconomy.com highlighted that Johnson & Johnson was planning to use a bioengineered strain of listeria bacteria, which is ingested by a type of immune system cell called dendritic cells to ‘teach’ T-cells, known as the immune systems’ “fighter” cells, to attack cancer.

According to the report, the bacteria might be combined with a prostate cancer vaccine called GVAX, which Aduro acquired in 2013, in order to increase that vaccine’s effectiveness.

In a statement provided to Global Health and Travel, Marco Gottardis, vice president and prostate cancer disease area leader for Janssen Research & Development LLC, part of Janssen Pharmaceuticals, Johnson & Johnson’s pharmaceutical arm, said that the company’s listeria technology, known commercially as LADD, could be used in tandem with the company’s other immunotherapy products.

“We anticipate that LADD-based prostate cancer immunotherapies could be used in combination with other Janssen products, including ZYTIGA, which has been approved for prostate cancer, as well as ARN509, which is currently in latestage clinical trials,” Gottardis said.

In 2013, Roche signed a US$17 million deal with German cancer vaccine manufacturer Immatics to develop IMA942, a cancer vaccine aimed at gastric, prostate and non-small cell lung cancer.

Roche also invested US$10 million with another vaccine maker, US-based Inovio, to develop another type of cancer vaccine known as a synthetic DNA vaccine that would target prostate cancer, but terminated its relationship with Inovio in November 2014, according to a Scrip Intelligence report.

Inovio is now planning to move the vaccine into Phase I testing independently in the first half of 2015, the report said.


The benefits of a natural antibody response

The field of therapeutic cancer vaccines is relatively new and distinct from earlier-generation immunotherapies like monoclonal antibodies, an immunotherapy drug type that relies on laboratory-produced antibodies that bind to cancer cell proteins, thus enabling the immune system to target the cancer.

The list of FDA-approved monoclonal antibody therapies includes Yervoy as well as Herceptin, a monoclonal antibody-based drug manufactured by Roche used to treat HER-2 positive breast cancer.

A main difference between cancer vaccines and monoclonal antibodies is that cancer vaccines act as an “active” stimulator of the immune system as opposed to a “passive” stimulator, says Dr. Anna Ferrari, professor of oncology at New York University’s Langone Medical Center.

“In contrast to monoclonal antibodies, cancer vaccines are ‘active’ immunotherapy treatments because through various means (live or dead cells, viral vectors, DNA fragments or peptides) they train the host’s immune system to recognise tumour cells by one or more specific antigens and mount an innate, long lasting response against them,” Dr. Ferrari says.

Monoclonal antibodies, in contrast, are a ‘passive’ immunotherapy treatment because they rely on an artificiallyproduced antibody to generate the immune system response, instead of stimulating the body’s immune system to produce its own antibodies that can target proteins found on cancer cells.

“Therefore, [passive immunotherapies] require repeated administration to sustain efficacy,” she says.

These benefits are being touted by cancer vaccine manufacturers such as Australia-based Imugene, which is developing a cancer vaccine that targets the tumour antigen known as HER-2, found in some breast and gastric cancers.

The vaccine would compete with Roche’s Herceptin, a monoclonal antibody drug also directed at HER-2.

Charles Walker, CEO of Imugene says that his company’s vaccine, HER-Vaxx, which is set to begin Phase II clinical trials, could eliminate a number of problems with monoclonal antibody treatment.

These include the problem of the body developing resistance to the drug, which can limit the number of doses the patient can receive; and secondly, reducing the chance of side effects such as congestive heart failure.

“Herceptin is an artificial antibody, and its job is limited in what it does,” Walker says. “The human system making its own antibodies is always going to be better than an antibody made in a factory.”

Because they require lab-produced antibodies adapted from other animals like mice, monoclonal antibody drugs are also very expensive – Herceptin, for example, can cost up to US$70,000 per year, Walker says.

However, the research behind Herceptin – which identified the HER-2 protein – has enabled companies like Imugene to try to build an improved treatment that would also be more cost effective.

“When HER-Vaxx works, it has the chance of delivering a number of benefits to patients, including better survival outcomes, decreased side effects and lower cost,” Walker says.

“While improving side effects and cost of therapy is attractive, our real aspiration is that we can get a patient’s own immune system to work many times better than Herceptin, and deliver improved outcomes for patients.”


Cancer vaccine developers struggle to overcome the ‘valley of death’

Despite the millions being invested in cancer vaccines, only one therapeutic vaccine – Provenge, a cancer vaccine for prostate cancer manufactured by Dendreon, has thus far managed to grab FDA approval. Even so, Provenge has not performed well in the market due to its steep price tag and limited ability to prolong survival.

Patients treated with Provenge are expected to live an average of four months more compared to those who did not undergo the treatment. Additionally, it comes at the hefty cost of US$93,000 per treatment, according to American Cancer Society figures.

Although a few months increase in life expectancy could mean a lot from patients’ standpoint, the real challenge is how to build on the progress made possible by Provenge in order to provide cancer patients with better outcomes.

“Provenge is excellent in that it shows immunotherapy can work,” Charles Walker of Imugene says.

“While there have been commercial limitations for the drug, it’s still proven the concept.”

Another difficulty for developers is proving that cancer vaccines can be effective in a large sample of patients.

One notable failure was major pharmaceutical Merck’s announcement in September 2014 that it would discontinue its late-stage vaccine Stimuvax, directed at non-small cell lung cancer, after it “flunked” a Phase III trial in Japan, biotech blog Fiercevaccines.com reported.

Earlier that year, GlaxoSmithKline’s Phase III trial for its non-small cell lung cancer vaccine MAGE-A3 suffered a similar fate.

According to Angus Dalgleish, professor of oncology at St. George’s University of London, some previous cancer vaccine trials which held promise in the early stages eventually fell through due to a variety of factors, including poor patient selection and inappropriate administration of the vaccine.

One potential explanation for this is an inconsistency among the centres involved in the trials.

In a 2011 paper published in the journal Vaccine, Professor Dalgleish wrote that some researchers testing cancer vaccines used intradermal injection, which is in between the upper and lower layers of the skin, while others administered the vaccine subcutaneously, in the fat layer underneath the skin.

Other researchers disagree. Dr. Toh Han Chong of NCCS says he doubts that the way the vaccine is administered is a key driver for the outcome of cancer vaccine trials.

“While there is some scientific evidence that intradermal injection may be better than the subcutaneous route for cancer vaccines, there is no concrete evidence that it confers a real advantage; this is certainly not the reason why therapeutic cancer vaccines fail in late-stage clinical trials,” Dr. Toh says.

In his paper for Vaccine, Professor Dalgleish also notes that the patients’ overall motivation to fight cancer, especially their attention to a healthy diet and exercise, can differ among multiple testing centres, thus affecting trial outcomes.

“Having visited several centres recruited for the randomised studies I was struck by the difference in general health and self-motivation of patients recruited compared to those in the principal centre,” he wrote.

Professor Dalgleish has been integrating the experience he made by analysing previous failures in cancer vaccine trials into the development of another cancer vaccine known as IMM- 101 for pancreatic cancer, which actually he prefers not to call a “vaccine.”

Thus far, the vaccine, which is in Phase II trials, has been tested in 110 patients, and has proved to offer an average increase in survival that adds up to about three months with no toxicity, Dalgleish says.

“The IMM-101 project started off life as a vaccine, we now wish to call it an injectable immune modulator, as cancer vaccines have been given a bad name by big pharmaceuticals, who have trialled many cancer vaccines which have all failed as they are single antigen based.

IMM-101 is a multi-antigen product which is why it works,” he says. Wary of the numerous failures in the cancer vaccine field, drug developers are trying to learn from each others’ mistakes.

Pharmaceutical giant Pfizer is currently in preclinical testing of a therapeutic cancer vaccine for prostate cancer that the company says may have a better chance of success than some of its predecessors, because it addresses a fundamental problem with earlier vaccines — the fact that those vaccines were too focused on specific antigens found on cancer cells.

“By and large, most of the common antigen approaches as a vaccine immunotherapy have had limited success,” Dr. John Lin, vice president of experimental medicine and cancer immunotherapy for Pfizer, told Global Health and Travel while attending The Economist magazine’s “War on Cancer: Enemy of the State” conference in Hong Kong on Mar. 20.

“Some tumour cells may express a high level of that particular antigen, and yet other tumour cells may have very little expression. When you try to elicit an immune response to that particular antigen, maybe some tumour cells will be eliminated, but some tumour cells in the same tumour may not be eliminated.”

“One of the big considerations when it comes to our own cancer vaccine program is that we don’t believe a single antigen is sufficient. We want to make it less restrictive, in the sense that we include more than one antigen,” Dr. Lin says.

Another possible explanation for the high rate of failures in late-stage cancer vaccine trials is the employment of an inappropriate framework to analyse potential outcomes.

According to Charles Walker of Imugene, in past years researchers used the parameters for chemotherapy effectiveness as the basis to evaluate cancer vaccines.

For example, if the tumour was seen to enlarge after the administration of the vaccine, the trial could have been deemed unsuccessful and consequently stopped.

This paradigm is useful in determining the efficacy of chemotherapy, which is supposed to decrease or at least stabilise the size of the tumour, but it can be misleading when it comes to evaluating the effectiveness of immunotherapy.

Professor Ferrari of NYU says that even though the tumour’s size can increase immediately following immunotherapy treatment, the patient’s survival may improve.

“The immune anti-tumour response does not cause tumour shrinkage as observed with cytotoxic chemotherapy but leads to significant delay in progression and longer overall survival with minimal toxicity or compromise in quality of life,” she says.


Could a breakthrough in cancer vaccine research be on the horizon?

Given the daunting challenges in developing a cost-effective cancer vaccine that can significantly prolong life in a wide range of patients, researchers realise that alternative logic may be necessary to break through barriers that the cancer vaccine field is currently facing.

Dr. Brendon Coventry, an associate professor of surgery at the University of Adelaide and Martin Ashdown, a research fellow at the University of Melbourne, may have found one of the keys to increasing effectiveness of a broad range of immunotherapies.

The pair of researchers focused on Interleukin-2 (IL-2), a hormone that stimulates immune system cells to grow faster and it is usually employed as a treatment for kidney cancer and metastatic melanoma, and tried to make sense of its apparently random seven percent rate in leading patients towards total remission.

They discovered that IL-2 is able to activate an immune response only if the immune cells have a specific receptor detecting IL-2. Unfortunately, these receptors are present on immune cells just for a determined slot of time ranging from eight to 12 hours before fading away.

And this period varies from patient to patient as each individual has a distinctive immunological cycle.

“If we could accurately target the therapeutic window at the correct time-point in each patient’s immune cycle, this would make responses to therapy much more predictable and would lead to a real possibility of treatment success that is much closer to 100 percent,” Dr. Coventry and Ashdown wrote in the June 2014 cover story of Australasian Science Magazine. This led the researchers to claim that they could have unravelled a sort of “Rosetta Stone” for cancer.

The one of a kind piece of rock was discovered in 1799 and made the understanding of hieroglyphics possible for the first time by providing the same inscriptions in three different languages: hieroglyphics, demotic and Greek. Interleukin-2 is believed to offer similar information to decipher the proper time to deliver immunotherapies and make them successful.

The two researchers have examined serial blood samples to figure out how to identify patients’ immunological cycle and they have eventually personalised each therapy to match it with the right slot of time.

“These examples indicate that the techniques we propose are both achievable and effective, but require improvement, testing and wider acceptance,” they wrote in Australasian Science. In an interview with Global Health and Travel, Dr. Coventry says that this theory also applies to cancer vaccine administration.

“The immune system is in a process most of the time of either turning off and turning on to keep it relatively constant, but not absolutely constant,” he said. “And therefore, ‘when’ the vaccine is given in this particular cycle that’s going on in the patient, it will be particularly important as to whether a response against the cancer gets generated or not.”

“The ‘therapeutic window’ for enhancing the immune response lies somewhere around each ‘trough’ in the patient’s individual immune cycle,” Dr. Coventry says. “This window is available to any agent that can stimulate the immune system, including exogenously administered IL-2 and vaccines.”

Although immunotherapies, including cancer vaccines, have been receiving a huge chunk of the attention and investment in the oncology world as of late, Dr. John Lin of Pfizer says that his company is not discounting the development of other nextgeneration treatments, such as targeted cancer therapies, that would eventually take their place alongside chemotherapy and radiotherapy as benchmark treatments.

Another important thing to remember is that developing combination treatments, as opposed to standalone treatments, will probably have the best chance at improving patient outcomes, he says. “Eventually, if you want patients to benefit the most, you will need some sort of combination.

Hopefully we can move away from the traditional radiation and chemotherapy into less toxic and more specific therapy like targeted therapies and immunotherapy,” Dr. Lin says.

“Even with the best immunotherapy that is currently available, it will probably not be sufficient by itself,” he says.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 17 Apr 2015 06:10:00 -0400 https://www.proactiveinvestors.com/companies/news/68161/cancer-vaccines-immunotherapys-new-wave-79420.html
<![CDATA[News - Imugene shares rise on heavy volume ]]> https://www.proactiveinvestors.com/companies/news/66436/imugene-shares-rise-on-heavy-volume-77534.html Imugene (ASX:IMU) shares rose 33.3% on Friday to $0.012 with more than 13 million shares traded, well above the average daily trading volume of around 855,000 shares as investors twig to milestones ahead for the biotech company.

It is due to advance its HER-Vaxx peptide vaccine into additional human Phase Ib/II gastric cancer clinical trials later this year.

The share movement and trading volume increased produced a standard price and volume query from the ASX to which the company responded it was unaware of any information not already announced that could be responsible.

It noted the recent investor presentation released to ASX on 10th February 2015 and the subsequent investor roadshow.

Her-Vaxx, a B-cell based immunotherapy for HER-2 positive gastric and breast cancer, has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

Earlier last week, Imugene received a $230,690 tax refund under the Australian Government’s Research and Development Tax Incentive Scheme.

These funds complement the company’s $3.5 million capital raising announced in December.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 23 Feb 2015 10:00:00 -0500 https://www.proactiveinvestors.com/companies/news/66436/imugene-shares-rise-on-heavy-volume-77534.html
<![CDATA[News - Imugene banks research and development tax refund ]]> https://www.proactiveinvestors.com/companies/news/66344/imugene-banks-research-and-development-tax-refund-77434.html Imugene (ASX:IMU) has received a $230,690 tax refund under the Australian Government’s Research and Development Tax Incentive Scheme.

These funds complement the company’s $3.5 million capital raising announced in December and will contribute to the progression of the company’s main asset, the HER-Vaxx peptide vaccine.

The vaccine is due to enter additional human Phase Ib/II gastric cancer clinical trials later this year.

Her-Vaxx, a B-cell based immunotherapy for HER-2 positive gastric and breast cancer, has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

“Imugene’s research capability is strengthened by this financial support. This clinical research on
HER-Vaxx is attempting to develop much better treatments for HER2-positive gastric, breast and other cancers and is striving to help sufferers and benefit healthcare,” managing director Charles Walker.

“Our endeavour is to achieve one or more breakthroughs in these areas with superior commercial products. This non-dilutive funding helps us move down this path. I expect Imugene to continue to benefit from this innovative R&D refund scheme in future years.”


HER-Vaxx

HER-Vaxx is a proprietary peptide vaccine or immunotherapy that causes the immune system to generate cancer-fighting antibodies.

It achieves this by stimulating a polyclonal antibody response to HER-2/neu.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015 following the appointment of a CRO to manage the trial.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Wed, 18 Feb 2015 11:00:00 -0500 https://www.proactiveinvestors.com/companies/news/66344/imugene-banks-research-and-development-tax-refund-77434.html
<![CDATA[News - Imugene progressing cancer vaccine towards clinical studies ]]> https://www.proactiveinvestors.com/companies/news/66177/imugene-progressing-cancer-vaccine-towards-clinical-studies-77253.html Imugene (ASX:IMU) is preparing to initiate this year the clinical program for its Her-Vaxx peptide vaccine, a B-cell based immunotherapy for HER-2 positive gastric & breast cancer.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

Charles Walker, managing director. outlined these points and many others at the February 2015 Proactive Investors Melbourne / Sydney Luncheons.

The full presentation can be ACCESSED HERE.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 12 Feb 2015 15:00:00 -0500 https://www.proactiveinvestors.com/companies/news/66177/imugene-progressing-cancer-vaccine-towards-clinical-studies-77253.html
<![CDATA[News - Imugene therapy targets cancer at Melbourne, Sydney Luncheons ]]> https://www.proactiveinvestors.com/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.html Imugene (ASX:IMU) is preparing to initiate this year the clinical program for its Her-Vaxx peptide vaccine, a B-cell based immunotherapy for HER-2 positive gastric & breast cancer.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.


Proactive Investors has secured MD Charles Walker to present to investors at the "Melbourne Investor Luncheon" on Tuesday 10th February and the "Sydney Investor Luncheon" on Wednesday 11th February.

REGISTER by clicking on the city below for additional details: Melbourne OR Sydney. Otherwise call (02) 9299 5001(02) 9299 5001 and ask for John.


HER-Vaxx is a proprietary peptide vaccine developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

It causes the immune system to generate cancer-fighting antibodies by stimulating a polyclonal antibody response to biomarker HER-2/neu.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015.

Recently, Imugene achieved two milestones, substantially finalising the clinical protocol for the Phase Ib/II clinical trial and appointing respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies.


Multiple price catalysts for near term valuation increase

- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 06 Feb 2015 10:11:00 -0500 https://www.proactiveinvestors.com/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.html
<![CDATA[News - Imugene Limited appoints Charles Walker as managing director ]]> https://www.proactiveinvestors.com/companies/news/65847/imugene-limited-appoints-charles-walker-as-managing-director-76878.html Australian immuno-oncology company Imugene Limited (ASX:IMU) has appointed Charles Walker as managing director, and will be appointed to the board with immediate effect.

Imugene is developing a B-cell based immunotherapy, known as HER-Vaxx, for HER-2 positive gastric & breast cancer.

Walker who was previously CEO, has already overseen an important period for the company including the significant advancement of product development activities, in addition to overseeing the recent capital raising.

The Phase I trial is completed in patients with HER2+/++ breast cancer, with Phase I/II trial to begin 2H 2015.

The technology originates from Medical University of Vienna, one of Europe’s leading cancer institutes.


Milestones

Recently the company advanced two additional milestones as it prepares to initiate the clinical program for its Her-Vaxx peptide vaccine in 2015.

The company has substantially finalised the clinical protocol for the Phase Ib/II clinical trial in patients with gastric cancer.

It has also appointed respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies to support the clinical trial planned by the company.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.


Multiple price catalysts for near term valuation increase

- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018


Analysis

Imugene has recently achieved two important milestones as it continues preparations to initiate the clinical program for its Her-Vaxx peptide vaccine in the second half of 2015

The finalisation of the clinical protocol for the Phase Ib/II clinical trial and appointment of WIL Research to conduct important FDA IND enabling preclinical studies are both key steps towards conducting an efficient high quality Phase II trial that will draw attention from pharmaceutical companies.

HER-Vaxx is one of the most advanced B-cell vaccines, designed to stimulate a patient’s own immune system to repeatedly attack the cancer.

Imugene is focused on a 24 month program to deliver results/value inflection.

The current market cap of circa $12 million (of which $3 million is cash) significantly undervalues the stock on upcoming milestones.

Proactive considers that investors have not wholly tweaked to the "new" Imugene as yet, providing opportunities for investors with the share price hovering at $0.01

Proactive Investors has estimated a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 02 Feb 2015 15:00:00 -0500 https://www.proactiveinvestors.com/companies/news/65847/imugene-limited-appoints-charles-walker-as-managing-director-76878.html
<![CDATA[News - Imugene hits milestones on the road to Her-Vaxx 2015 clinical program ]]> https://www.proactiveinvestors.com/companies/news/156514/imugene-hits-milestones-on-the-road-to-her-vaxx-2015-clinical-program-59822.html Australian immuno-oncology company Imugene (ASX:IMU) has met two more milestones as it prepares to initiate the clinical program for its Her-Vaxx peptide vaccine in 2015.

The company has substantially finalised the clinical protocol for the Phase Ib/II clinical trial in patients with gastric cancer.

It has also appointed respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies to support the clinical trial planned by the company.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

Imugene chief executive officer Charles Walker said the milestones emphasised the company’s focus to conduct an efficient high quality Phase II trial that pharmaceutical companies prefer to see.
   
“The next step is to appoint an internationally regarded CRO in 1H 2015 to efficiently manage the clinical trial. The trial remains on track to start in the second half of next year.”

The company has raised over $3.5 million through two recent placements and a share purchase plan to fund development of Her-Vaxx.

WIL Research is a global CRO that provides a range of premium discovery support services, product safety toxicological research, analytical chemistry and formulation services.

It has over 1,200 employees across world-class facilities in the US, Netherlands, France and Japan.   


HER-Vaxx

HER-Vaxx is a proprietary peptide vaccine or immunotherapy that causes the immune system to generate cancer-fighting antibodies..

It achieves this by stimulating a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.4 billion per annum drug Herceptin.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015 following the appointment of a CRO to manage the trial.

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered.  This will include 18 patients divided into 3 groups of 6.

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks.

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy.

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.

This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.


Gastric cancer global overview

Gastric cancer is the second leading cause of cancer mortality, and the fourth most common cancer in the world. Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year.

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year.

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.


Multiple share price catalysts for near term valuation increase

- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018


Analysis

Imugene has achieved two milestones as it continues preparations to initiate the clinical program for its Her-Vaxx peptide vaccine in the second half of 2015

The finalisation of the clinical protocol for the Phase Ib/II clinical trial and appointment of WIL Research to conduct important FDA IND enabling preclinical studies are both key steps towards conducting an efficient high quality Phase II trial that will draw attention from pharmaceutical companies.

With significant news flow and price catalysts milestones in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines in sight, there is potential for the current valuation to lift in 2014/15.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has estimated a 6-12 month share price target of $0.034 - $0.047.


 
Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 30 Dec 2014 11:58:00 -0500 https://www.proactiveinvestors.com/companies/news/156514/imugene-hits-milestones-on-the-road-to-her-vaxx-2015-clinical-program-59822.html
<![CDATA[News - Imugene director increases indirect interest through share placement ]]> https://www.proactiveinvestors.com/companies/news/64624/imugene-director-increases-indirect-interest-through-share-placement-75485.html Imugene (ASX:IMU) non-executive director Otto Buttula has increased his indirect interests in the company through participation in the recent share placement priced at $0.01 per share.

Indirect interests of Buttula acquired 15 million shares for $150,000. This brings his indirect interest up to 77 million shares.

Separately, executive chairman Paul Hopper’s indirect interests acquired 1.5 million shares for $15,000 under the company’s share purchase plan.

Hopper now indirectly holds 69,796,875 shares in the company.

Imugene recently raised over $3.5 million from its recent placements and share purchase plan.

Proceeds will be used for the development of HER-Vaxx, Imugene’s peptide vaccine that causes the immune system to generate cancer-fighting antibodies.

Her-Vaxx has potential to improve upon Roche Holdings Ltd’s (US$251.1 billion valuation) blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.



Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Tue, 16 Dec 2014 13:30:00 -0500 https://www.proactiveinvestors.com/companies/news/64624/imugene-director-increases-indirect-interest-through-share-placement-75485.html
<![CDATA[Media files - Imugene Limited CEO Charles Walker speaks about using Immuno-oncology in the fight against cancer ]]> https://www.proactiveinvestors.com/companies/stocktube/5740/imugene-limited-ceo-charles-walker-speaks-about-using-immuno-oncology-in-the-fight-against-cancer-471.html Wed, 10 Dec 2014 11:27:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/5740/imugene-limited-ceo-charles-walker-speaks-about-using-immuno-oncology-in-the-fight-against-cancer-471.html <![CDATA[News - Imugene meets heavy demand in capital raising for HER-Vaxx ]]> https://www.proactiveinvestors.com/companies/news/64390/imugene-meets-heavy-demand-in-capital-raising-for-her-vaxx-75222.html Australian immuno-oncology company Imugene (ASX:IMU) has now raised over $3.5m across two recent placements and a share purchase plan, which will be used for the development of HER-Vaxx.

This included an additional 50,000,000 shares issued to cater for the demand.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

HER-Vaxx technology is compelling science that was developed by one of Europe’s leading cancer institutes. Approximately $10 million has already been invested in the technology.

From January 2013 to August 2014 an index made up of U.S. immuno-oncology companies increased in value by 262.9%, when compared to a NASDAQ biotechnology index that increased by 102.2%, and the S&P500 that increased by 40.5%.


Capital raising details

The company's share purchase plan raised $833,500, while an additional $500,000 was placed to sophisticated investors of Forrest Capital at $0.01 after unexpected demand.

This placement is in addition to the recent placement of $2.25 million.

The funds raised will support the manufacture of HER-Vaxx including initiation of clinical trials, the company’s Phase 1b/2 clinical trial in patients with metastatic gastric cancer, preclinical work, corporate costs, intellectual property prosecution and general corporate purposes.

Charles Walker, CEO, commented: “We thank the investors who participated in the SPP and placement for their ongoing support of the company and we look forward to updating the market as we make progress on our milestones in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines, and a highly promising novel treatment for gastric cancer.”


HER-Vaxx

HER-Vaxx is a peptide vaccine or immunotherapy. The peptide component in HER-Vaxx is the component that causes the immune system to generate cancer-fighting antibodies.

As part of the ongoing preclinical work announced on 8th September 2014, the research of Professor Ursula Wiedermann has also found that the generated antibodies recognise native HER-2 protein, a result critical for eventual efficacy.

Professor Wiedermann, who is leading the research, is a member of the Imugene Scientific Advisory Board and was the principal investigator for the preclinical development of HER-Vaxx.

She is also leading the design of the HER-Vaxx Phase Ib/II study for gastric cancer due to commence in 2015.

HER-Vaxx is a proprietary therapeutic cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.4 billion per annum drug Herceptin®.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer and the next stage of development will be a Phase Ib/II study in patients with gastric cancer.


What is immuno-oncology?

Immuno-oncology is an emerging therapeutic approach that is being studied for its potential in the fight against cancer and focuses on an understanding of how cancer evades the immune system of a patient.

This approach is different from ways of treating cancer because it uses the natural capability of the patient’s own immune system to fight the cancer. 

Imugene’s technology is being developed to stimulate a patient’s immune system to produce its own antibodies to a known and validated target for cancer which is the HER-2 receptor that is expressed on various tumours that include gastric, breast, ovarian, lung, and pancreatic cancers.

HER-Vaxx is a cancer immunotherapy designed to stimulate a patient’s own immune system to attack the cancer. HER-Vaxx stimulates a patient’s B cells to produce antibodies that target only those cancer cells where HER-2 receptors are present on their surface. Approximately 20% -30% of all patients with gastric, breast, ovarian and pancreatic cancer have this HER-2 molecule, and are known as being HER-2 positive. 

The HER-2 molecule stimulates the growth of cancer cells, and an “over expression” of HER-2 is typically associated with a higher chance that the patient’s cancer will spread, or produce a greater probability of cancer recurrence.

Roche Holdings Ltd (US$251.1 billion valuation) owns Herceptin which is an antibody that targets the HER-2 receptor in breast and gastric cancer and reported annualised sales of $6.9 billion. Roche’s newly launched Perjeta also targets the HER-2 receptor.

Imugene believes that the successful development of HER-Vaxx has the potential to improve upon both Herceptin and Perjeta, as the HER-Vaxx P4, P6 and P7 peptides can bind onto the HER-2 receptor at 3 different points, as opposed to two points each for Perjeta or Herceptin.


Phase one clinical trial completed successfully for HER-Vaxx

A Phase I clinical trial was completed at the University of Vienna that included 10 patients, who all had metastatic breast cancer along with over expression of HER-2.   

The study confirmed that HER-Vaxx produced negligible toxicity and was tolerated by patients with no side effects. Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response. 

The trial data is encouraging given that it was conducted in a non-target population, with the disease stabilising in 5 patients, and 1 patient going into remission. 


Proposed clinical trials for HER-Vaxx – Phase II for gastric cancer

A combined Phase Ib and Phase II Trial is now planned to confirm safety, evaluate optimal dosing, and to show efficacy. 

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered.  This will include 18 patients divided into 3 groups of 6. 

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks. 

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy. 

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.

This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.


Gastric cancer global overview

Gastric cancer is the second leading cause of cancer mortality, and the fourth most common cancer in the world. Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year. 

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year. 

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.


Multiple share price catalysts for near term valuation increase

- Finalise trial protocol 2H 2014
- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018


Analysis

Imugene has received strong support from the investment community to raise in total over $3.5 million from placements and a share purchase plan.

This included an additional 50,000,000 shares issued to cater for the demand.

Earlier in the month the company delivered yet another milestone in preclinical testing, with the team at the Medical University of Vienna showing that high HER-2-specific antibody levels have been generated using HER-Vaxx fusion peptide antigens, in preclinical testing.

This demonstrates that the HER-Vaxx fusion peptide antigens are strongly immunogenic.

With significant news flow and price catalysts milestones in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines in sight, there is potential for the current valuation to lift in 2014/15. 

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has estimated a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Tue, 09 Dec 2014 11:33:00 -0500 https://www.proactiveinvestors.com/companies/news/64390/imugene-meets-heavy-demand-in-capital-raising-for-her-vaxx-75222.html
<![CDATA[News - Imugene's HER-Vaxx demonstrates high level of activity in preclinical testing ]]> https://www.proactiveinvestors.com/companies/news/64118/imugenes-her-vaxx-demonstrates-high-level-of-activity-in-preclinical-testing-74923.html Australian immuno-oncology company Imugene Limited (ASX:IMU) has delivered yet another milestone in preclinical testing.

The team at the Medical University of Vienna has shown that high HER-2-specific antibody levels have been generated using HER-Vaxx fusion peptide antigens, in preclinical testing.

This demonstrates that the HER-Vaxx fusion peptide antigens are strongly immunogenic.

Antibodies recognised native HER-2 receptor.

HER-Vaxx technology is compelling science that was developed by one of Europe’s leading cancer institutes. Approximately $10 million has already been invested in the technology.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Charles Walker, chief executive officer, commented: “These pleasing results form part of our preclinical testing needed to submit an IND and begin clinical testing with HER-Vaxx in patients with gastric cancer.

"It is gratifying to see strong results continuing to be generated, particularly with our more potent fusion peptides.

"We look forward to reporting continued progress in line with our plan to develop HER-Vaxx.”


HER-Vaxx

HER-Vaxx is a peptide vaccine or immunotherapy. The peptide component in HER-Vaxx is the component that causes the immune system to generate cancer-fighting antibodies.

As part of the ongoing preclinical work announced on 8th September 2014, the research of Professor Ursula Wiedermann has also found that the generated antibodies recognise native HER-2 protein, a result critical for eventual efficacy.

Professor Wiedermann, who is leading the research, is a member of the Imugene Scientific Advisory Board and was the principal investigator for the preclinical development of HER-Vaxx.

She is also leading the design of the HER-Vaxx Phase Ib/II study for gastric cancer due to commence in 2015.

HER-Vaxx is a proprietary therapeutic cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu, the same biomarker targeted by the $US6.4 billion per annum drug Herceptin®.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer and the next stage of development will be a Phase Ib/II study in patients with gastric cancer.


What is immuno-oncology?

Immuno-oncology is an emerging therapeutic approach that is being studied for its potential in the fight against cancer and focuses on an understanding of how cancer evades the immune system of a patient.

This approach is different from ways of treating cancer because it uses the natural capability of the patient’s own immune system to fight the cancer. 

Imugene’s technology is being developed to stimulate a patient’s immune system to produce its own antibodies to a known and validated target for cancer which is the HER-2 receptor that is expressed on various tumours that include gastric, breast, ovarian, lung, and pancreatic cancers.

HER-Vaxx is a cancer immunotherapy designed to stimulate a patient’s own immune system to attack the cancer. HER-Vaxx stimulates a patient’s B cells to produce antibodies that target only those cancer cells where HER-2 receptors are present on their surface. Approximately 20% -30% of all patients with gastric, breast, ovarian and pancreatic cancer have this HER-2 molecule, and are known as being HER-2 positive. 

The HER-2 molecule stimulates the growth of cancer cells, and an “over expression” of HER-2 is typically associated with a higher chance that the patient’s cancer will spread, or produce a greater probability of cancer recurrence.

Roche Holdings Ltd (US$251.1 billion valuation) owns Herceptin which is an antibody that targets the HER-2 receptor in breast and gastric cancer and reported annualised sales of $6.9 billion. Roche’s newly launched Perjeta also targets the HER-2 receptor.

Imugene believes that the successful development of HER-Vaxx has the potential to improve upon both Herceptin and Perjeta, as the HER-Vaxx P4, P6 and P7 peptides can bind onto the HER-2 receptor at 3 different points, as opposed to two points each for Perjeta or Herceptin.


Analysis

Today's results demonstrate that the HER-Vaxx fusion peptide antigens are strongly immunogenic.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 01 Dec 2014 13:04:00 -0500 https://www.proactiveinvestors.com/companies/news/64118/imugenes-her-vaxx-demonstrates-high-level-of-activity-in-preclinical-testing-74923.html
<![CDATA[News - Imugene Limited extends share purchase plan ]]> https://www.proactiveinvestors.com/companies/news/64112/imugene-limited-extends-share-purchase-plan-74917.html Immuno-oncology company Imugene Limited (ASX:IMU) has granted shareholders additional time to increase their holdings in the company at the same price as a recent $2.1 million placement to sophisticated investors.

The share purchase plan allows subscriptions for between $1,000 and $15,000 at $0.01, and has now been extended by one week to Friday 5th December 2014.

The company last traded above the offer price at $0.011.

Imugene is developing B-cell based immunotherapies, known as HER-Vaxx for HER-2 positive gastric and breast cancer.

Immunotherapy has become one of the hottest and most promising areas of study for the treatment of a variety of cancerous tumours, and includes a just announced joint venture between Pfizer and Merck to commence on up to 20 preclinical immuno-oncology programs in 2015.

From January 2013 to August 2014 an index made up of U.S. immuno-oncology companies increased in value by 262.9%, when compared to a NASDAQ biotechnology index that increased by 102.2%, and the S&P500 that increased by 40.5%.

HER-Vaxx technology is compelling science that was developed by one of Europe’s leading cancer institutes. Approximately $10 million has already been invested in the technology.


Research Note and StockTube Video

Access the Research Note: Imugene is undervalued v ASX, global peers in Immuno-Oncology.

Access the StockTube Video: Imugene Limited CEO Charles Walker speaks about using Immuno-oncology in the fight against cancer.


Analysis

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 01 Dec 2014 09:00:00 -0500 https://www.proactiveinvestors.com/companies/news/64112/imugene-limited-extends-share-purchase-plan-74917.html
<![CDATA[News - Imugene to divest Linguet™, focus on HER-Vaxx for gastric cancer ]]> https://www.proactiveinvestors.com/companies/news/64074/imugene-to-divest-linguet-focus-on-her-vaxx-for-gastric-cancer-74869.html Imugene Limited (ASX:IMU) will divest its Linguet™ drug delivery technology, allowing the company to focus on HER-Vaxx for gastric cancer, one of the world’s most advanced B cell vaccines.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.


Linguet™ divestment

Linguet™ uses proprietary technology to improve the efficacy and safety of a diverse number of existing prescription and over-the-counter medicines.

Imugene is seeking expressions of interest from parties to either purchase a 100% interest in Linguet™ via trade sale, licence or as a back door listing / distribution, with potentially priority rights awarded to Imugene shareholders.

The platform technology enables the active ingredients of drugs to be absorbed directly into the bloodstream when placed inside the cheek (buccal) or under the tongue (sublingual).


Core focus on HER-Vaxx

Imugene’s core focus will remain on developing its class leading immuno-oncology program, HER-Vaxx for gastric cancer.

HER-Vaxx is expected to enter Phase II clinical trials for gastric cancer in 2H 2015.

Immunotherapy has become one of the hottest and most promising areas of study for the treatment of a variety of cancerous tumours, and includes a just announced joint venture between Pfizer and Merck to commence on up to 20 preclinical immuno-oncology programs in 2015.

From January 2013 to August 2014 an index made up of U.S. immuno-oncology companies increased in value by 262.9%, when compared to a NASDAQ biotechnology index that increased by 102.2%, and the S&P500 that increased by 40.5%.


Research Note and StockTube Video

Access the Research Note: Imugene is undervalued v ASX, global peers in Immuno-Oncology.

Access the StockTube Video: Imugene Limited CEO Charles Walker speaks about using Immuno-oncology in the fight against cancer.


Analysis

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Imugene's share purchase plan is open until Friday 5th December 2014 allowing subscriptions for between $1,000 and $15,000 at $0.01.

Proactive Investors has a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 28 Nov 2014 10:37:00 -0500 https://www.proactiveinvestors.com/companies/news/64074/imugene-to-divest-linguet-focus-on-her-vaxx-for-gastric-cancer-74869.html
<![CDATA[News - Imugene Limited extends share purchase plan ]]> https://www.proactiveinvestors.com/companies/news/64034/imugene-limited-extends-share-purchase-plan-74826.html Immuno-oncology company Imugene Limited (ASX:IMU) has granted shareholders additional time to increase their holdings in the company at the same price as a recent $2.1 million placement to sophisticated investors.

The share purchase plan allows subscriptions for between $1,000 and $15,000 at $0.01, and has now been extended by one week to Friday 5th December 2014.

Imugene is developing B-cell based immunotherapies, known as HER-Vaxx for HER-2 positive gastric and breast cancer.

Immunotherapy has become one of the hottest and most promising areas of study for the treatment of a variety of cancerous tumours, and includes a just announced joint venture between Pfizer and Merck to commence on up to 20 preclinical immuno-oncology programs in 2015.

From January 2013 to August 2014 an index made up of U.S. immuno-oncology companies increased in value by 262.9%, when compared to a NASDAQ biotechnology index that increased by 102.2%, and the S&P500 that increased by 40.5%.

HER-Vaxx technology is compelling science that was developed by one of Europe’s leading cancer institutes. Approximately $10 million has already been invested in the technology.


Research Note and StockTube Video

Access the Research Note: Imugene is undervalued v ASX, global peers in Immuno-Oncology.

Access the StockTube Video: Imugene Limited CEO Charles Walker speaks about using Immuno-oncology in the fight against cancer.


Analysis

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has a 6-12 month share price target of $0.034 - $0.047.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>
Thu, 27 Nov 2014 22:39:00 -0500 https://www.proactiveinvestors.com/companies/news/64034/imugene-limited-extends-share-purchase-plan-74826.html
<![CDATA[News - Imugene is undervalued v ASX, global peers in Immuno-Oncology ]]> https://www.proactiveinvestors.com/companies/news/64036/imugene-is-undervalued-v-asx-global-peers-in-immuno-oncology-74828.html Imugene Limited (ASX:IMU) is an immuno-oncology company developing B-cell based immunotherapies, known as HER-Vaxx for HER-2 positive gastric and breast cancer.

Immunotherapy has become one of the hottest and most promising areas of study for the treatment of a variety of cancerous tumours, and includes a just announced joint venture between Pfizer and Merck to commence on up to 20 preclinical immuno-oncology programs in 2015.

From January 2013 to August 2014 an index made up of U.S. immuno-oncology companies increased in value by 262.9%, when compared to a NASDAQ biotechnology index that increased by 102.2%, and the S&P500 that increased by 40.5%.

HER-Vaxx technology is compelling science that was developed by one of Europe’s leading cancer institutes. Approximately $10 million has already been invested in the technology.

Imugene’s ownership of Her-Vaxx technology is protected by long life patents that do not expire until 2030

Imugene is focussed on a developmental pathway that will generate multiple catalysts and value inflexion points over the coming 12 months.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

A current Share Purchase Plan at $0.01 per share provides shareholders with an ability to acquire shares without brokerage costs.

Imugene is significantly undervalued when compared with its ASX peers, and even more undervalued when compared against listed global peers and against recent U.S. transactions in the same field (see analysis and valuation). 

Proactive Investors initiates a 6- 12 month share price target of $0.034 - $0.047. Speculative Buy.

IMAGE ONE: IMMUNE-ONCOLOGY SECTOR EXHIBITS VERY DYNAMIC APPRECIATION

 

ASX Code: IMU
Recommendation: Speculative Buy
Sector: Pharma & Biotech

Share price target: $0.034 - $0.047
Share Price: $0.01
52 Week -: High: $0.022/Low: $0.008
Current Ordinary Shares: 1,156.6M
Unlisted Options: 50.0M
Cash: $2.98M

Market Cap: $11.5M

Major Shareholders (pre-new issue)
Top 20 shareholders: 53.4%
WebInvest: 6.6% 
Tisia Nominees: 6.3% 
JK Nominees: 6.3%

Directors
Executive Chairman: Paul Hopper
Cheif Executive Officer: Charles Walker
Non-Executive Directors: Dr. Axel Hoos; Otto Buttula


BACKGROUND

Imugene Limited (ASX:IMU) is an ASX listed immuno-oncology focused biopharmaceutical company developing HER-2+ gastric and breast cancer immunotherapies.

In December 2013 the Company completed the purchase of Biolife Science, which owned the rights to an exciting gastric and breast immuno-oncology cancer drug, known as Her-Vaxx. This drug was under development at the Medical University of Vienna in Austria, one of the largest hospital campuses in Europe.

Her-Vaxx shows great promise as a potential treatment for Her-2 positive gastric and breast cancer, and has completed Phase 1 clinical trials in Europe.

Plans are well advanced to take the drug into Phase II trials next year, with Imugene driving an active manufacturing program which is now underway. In July 2014 the Company announced the engagement of Swiss-based Mymetics SA to exclusively develop and manufacture its HER-Vaxx cancer immunotherapy. Mymetics brings specialist experience and expertise to the formulation, manufacture, and quality assurance of virosomes which form the principal delivery mechanism for Imugene’s HER-Vaxx.


MANAGEMENT TEAM BOLSTERED AFTER ACQUISITION OF BIOLIFE SCIENCE

Imugene has assembled a distinguished team at Board and management level, both domestically and globally.

Dr. Axel Hoos of GlaxoSmithKline plc joined the Board in December of 2013. Dr. Hoos is an outstanding scientist that brings a wealth of experience in immuno-oncology to the Company, and was part of the team that developed Yervoy at BMS.

In August 2014 Charles Walker was appointed as Chief Executive Officer.  He is a seasoned biotech leader that has executed nearly 50 international fundraisings both as principal and advisor. Most recently he was CEO as well as former CFO of ASX listed biotech Alchemia Ltd (ASX:ACL) where he assisted with the launch and growth of sales of Alchemia’s first product, and the initiation of Phase II and Phase III clinical trials of an anticancer drug candidate, and establishment of collaborations with Astra Zeneca and Merck-Serono.  

The Board was also strengthened by the addition of Otto Buttula who has a very successful business track record, and has been an active investor in the biotechnology sector for a number of years. 

Dr. Nicholas Ede resigned as Executive Director, and assumed the management of the manufacturing of Her-Vaxx, a role where he has particular expertise as a highly credentialed peptide chemist.  

The management team also has the support of a distinguished Scientific Advisory Board from leading institutions that includes Professor Christophe Zelinski who is Director of the Oncology Division, Department of Medicine at the Medical University Vienna, Austria, Professor Ursula Wiedermann who is Professor of Vaccinology at the Medical University of Vienna, and Doctor Neil H. Segal who is an Oncologist at the Memorial Sloan Kettering Cancer Center in New York.      

INTELLECTUAL PROPERTY

Imugene has the rights to a family of patents and patent applications and trademarks that protect its core platform technologies via Biolife Science for HER-Vaxx.

The HER-Vaxx immunotherapy platform includes the global rights to three patents:

- ‘Vaccine against HER-2/neu Oncogene-associated Cancers’, protects specific HER-2 B-cell epitopes and is granted in Australia, Europe, Canada, the USA and Israel
- ‘HER-2/neu Multi-peptide Vaccine’, further protects specific HER2 B-cell epitopes and is granted in Australia, Europe, Israel and pending in Canada
- ‘Multi-epitope Vaccine for HER-2/neu-associated Cancers’, claims fusion peptides comprising three noncontiguous B cell epitopes from the extracellular domain of HER-2/neu linked to one another and coupled with a delivery system including a virosome. This patent was acquired from Pevion Biotech (Switzerland), protects “HER-Vaxx” in major markets until at least 2030. The patent is granted in the USA and is pending in Europe

Imugene will also seek patent protection for new intellectual property, including improvements to the platform technologies, and their applications. As a minimum, patent applications will be made in the US, the European Union, Canada, China, Japan, Australia and New Zealand and most other English-speaking countries.

The Company reports that there are no infringement issues or patent disputes with any parties.


WHAT IS IMMUNO-ONCOLOGY?

Immuno-oncology is an emerging therapeutic approach that is being studied for its potential in the fight against cancer and focuses on an understanding of how cancer evades the immune system of a patient.

This approach is different from ways of treating cancer because it uses the natural capability of the patient’s own immune system to fight the cancer. 

Imugene’s technology is being developed to stimulate a patient’s immune system to produce its own antibodies to a known and validated target for cancer which is the HER-2 receptor that is expressed on various tumors that include gastric, breast, ovarian, lung, and pancreatic cancers.

HER-Vaxx is a cancer immunotherapy designed to stimulate a patient’s own immune system to attack the cancer. HER-Vaxx stimulates a patient’s B cells to produce antibodies that target only those cancer cells where HER-2 receptors are present on their surface. Approximately 20% -30% of all patients with gastric, breast, ovarian and pancreatic cancer have this HER-2 molecule, and are known as being HER-2 positive. 

The HER-2 molecule stimulates the growth of cancer cells, and an “over expression” of HER-2 is typically associated with a higher chance that the patient’s cancer will spread, or produce a greater probability of cancer recurrence.

Roche Holdings Ltd (US$251.1 billion valuation) owns Herceptin which is an antibody that targets the HER-2 receptor in breast and gastric cancer and reported annualised sales of $6.9 billion. Roche’s newly launched Perjeta also targets the HER-2 receptor.

Imugene believes that the successful development of HER-Vaxx has the potential to improve upon both Herceptin and Perjeta, as the HER-Vaxx P4, P6 and P7 peptides can bind onto the HER-2 receptor at 3 different points, as opposed to two points each for Perjeta or Herceptin.

IMAGE TWO: HER-VAXX PEPTIDES BIND TO HER-2 RECEPTOR

 

PHASE ONE CLINICAL TRIAL COMPLETED SUCCESFULLY FOR HER-Vaxx

A Phase I clinical trial was completed at the University of Vienna that included 10 patients, who all had metastatic breast cancer along with over expression of HER-2.   

The study confirmed that HER-Vaxx produced negligible toxicity and was tolerated by patients with no side effects. Patients developed anti-HER-2 antibodies, and these antibodies displayed potent anti-tumour activity, showing immune response. 

The trial data is encouraging given that it was conducted in a non-target population, with the disease stabilising in 5 patients, and 1 patient going into remission. 

PROPOSED CLINICAL TRIALS FOR HER-Vaxx – PHASE II FOR GASTRIC CANCER 

A combined Phase Ib and Phase II Trial is now planned to confirm safety, evaluate optimal dosing, and to show efficacy. 

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered.  This will include 18 patients divided into 3 groups of 6. 

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks. 

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy. 

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.

This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.

GASTRIC CANCER-GLOBAL OVERVIEW

Gastric cancer is the second leading cause of cancer mortality, and the fourth most common cancer in the world. Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year. 

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year. 

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.

 

HER-Vaxx MANUFACTURING

IMAGE THREE: HER-VAXX MANUFACTURE


Imugene has engaged Mymetics SA, based in Switzerland, to exclusively manufacture and develop its cancer immunetherapy HER-Vaxx. Mymetics Corporation (OTC BB: MYMX) is a Swiss-based biotechnology company registered in the US developing next-generation preventative vaccines for infectious diseases.
 
Mymetics brings specialist experience and know-how in the manufacturing, formulation and quality aspects of all types of virosomes, including influenza-based virosomes, the key delivery component in Imugene’s peptide-based immunotherapy HER-Vaxx. 

Peptide vaccines have the benefit of being easy to construct and manufacture on a large scale. They are inexpensive and are off the shelf therapy.

Mymetics uses the same vaccine delivery platform for infectious diseases that Imugene is using for the immuno-oncology program. Both companies will work to exploit the potential value of influenza-based virosomes.

RECENT FUNDRAISING AND SHARE PURCHASE PLAN

On 12 November 2014 Imugene completed a $2.10 million fundraising (before costs) to sophisticated investors. The Company issued 210 million fully paid ordinary shares at a price of $0.01 per share, for total issued capital of 1,156.6 million shares.

Otto Buttula who is a Non-Executive Director of the Company subscribed for an additional $150,000. 

A Share Purchase Plan of up to $15,000 per shareholder issued at $0.01 per share is also open to shareholders that will close on 28 of November 2014. 

PURPOSE OF FUND RAISING

Funds raised will be applied to the manufacture of HER-Vaxx which is sufficient for initiating clinical trials, initiating Phase 1b/II clinical file in patients with metastatic gastric cancer, preclinical work, corporate costs, intellectual property prosecution, and general corporate purposes.

FINANCIALS

The net carrying value of the Company’s intangible assets of $6.9 million was predominately due to an increase of $5.8 million on the previous year, due to the acquisition of Biolife Science.

The September quarter 2014 cash burn was a very lean $340,000 after accounting for receipt of an R&D tax credit of $343,000. R&D for the quarter was $346,000 and administrative costs were an extremely low $60,000. 

Cash held was $2.98 million, before any funds flow in from the current Share Purchase Plan. 


MULTIPLE PRICE CATALYSTS FOR NEAR TERM VALUATION INCREASE

- Finalise trial protocol 2H 2014
- Appoint CRO to run clinical trial 1H 2015
- US FDA IND granted 1H 2015
- Appoint Principal Investigator 1H 2015
- Announce Preclinical toxicology results 1H 2015
- Announce Preclinical immunologic results 1H 2015
- Recruit and run lead in Phase 1b trial 2H of 2015
- Recruit and run Phase II double-blind randomized placebo-controlled phase II trial 2H 2015
- Report Phase I trial results 2H 2015 to 1H 2016
- Report Phase II results 2H 2017 to 1H 2018


ANALYSIS & VALUATION 

Imugene carries a market capitalisation of $11.5 million, of which $2.98 million is cash at bank. The Company is advancing into Phase I/II trials and is extremely undervalued when compared with its ASX peer biotechnology companies that are advancing into Phase II trials for a variety of cancers or application of immunotherapies. 

ASX listed peers include:

- Oncosil Medical (ASX:OSL) with Market Capitalisation of $37.3 million – Phase II trial
- Viralytics (ASX:VLA) with Market Cap: $57.0 million – Phase II trial
- Innate Immuno Therapeutics (ASX:IIL) Market Cap: $26.1 million – Phase II trial
- Bionomics (ASX:BNO) Market Cap: $212.0 million  - Phase II trial
- Benitec Biopharma (ASX:BLT) Market Cap: $70.1 million – Phase I trial
- Imugene (ASX:IMU) Market Cap: $11.5 million – Phase II trial

Average market capitalisation of the peer group is $69 million versus $11.5 million for Imugene.

Valuations for U.S. based biotechs in Phase I/ II trials range from:

- Tetralogic Pharmaceuticals Corporation (NASDAQ: TLOG) Market Cap: US$102.7 million to 
- Kite Pharma (NASDAQ: KITE) Market Cap: $1,600 million    

Recent Immuno-oncology licensing deals in the U.S. include:

- Newlink Genetics and Genentech for NLG919 in Phase I, with upfront payment of $150 million, and potential for a total $1,150 million
- F Star and BMS for FS-102 targeting HER-2 in Phase 1, with upfront payment of ~$50 million, and potential for a total $475 million
- Five Prime Therapeutics and BMS for immuno-oncology therapeutics at the discovery stage, with upfront payment of $20 million and potential for a total $351 million

This further highlights the potential metrics and upside potential for Imugene.

Successful trial results and progression; partnering with a Big Pharma and/or licensing agreements would add further to this valuation upside. Trial success will be richly rewarded.

Proactive Investors has applied a combination of metrics including:  imputed asset value, median valuation and arrived at a valuation for Imugene of between $39.8 million to $55.2 million. This translates to a share price valuation of $0.034 - $0.047 per share.

A Share Purchase Plan of up to $15,000 at $0.01 per share provides shareholders with an ability to acquire further shares without brokerage before 28 of November 2014.

 

Disclaimer

You understand and agree that no content published constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is suitable or advisable for any specific person. You further understand that none of the information providers or their affiliates will advise you personally concerning the nature, potential advisability, value or suitability of any particular security, portfolio of securities, transaction, investment strategy, or other matter.

The contributors make every effort to ensure that the information and material contained in this report is accurate and correct and has been obtained from reliable sources. However, no representation is made about the accuracy or completeness of the information and material and it should not be relied upon as a substitute for the exercise of independent judgment. Proactive Investors received a fee for this work.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 27 Nov 2014 09:02:00 -0500 https://www.proactiveinvestors.com/companies/news/64036/imugene-is-undervalued-v-asx-global-peers-in-immuno-oncology-74828.html
<![CDATA[News - Imugene Limited looks to boost funds for cancer research ]]> https://www.proactiveinvestors.com/companies/news/156513/imugene-limited-looks-to-boost-funds-for-cancer-research-58635.html Immuno-oncology company Imugene Limited (ASX:IMU) is heading to market with a capital raising.

The ASX has granted the company a trading halt, with its shares placed in pre-open.

Imugene is developing B-cell based immunotherapies, known as HER-Vaxx, for HER-2 positive gastric and breast cancer.

The halt will remain in place until the opening of trade on Wednesday 5th November 2014, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 03 Nov 2014 10:30:00 -0500 https://www.proactiveinvestors.com/companies/news/156513/imugene-limited-looks-to-boost-funds-for-cancer-research-58635.html
<![CDATA[News - Imugene to be granted patent for cancer vaccine in Israel ]]> https://www.proactiveinvestors.com/companies/news/156512/imugene-to-be-granted-patent-for-cancer-vaccine-in-israel-53848.html Imugene Limited (ASX:IMU) may trade firmer after the Israeli Patent Office issued an Intention to Grant for its proprietary cancer vaccine, HER-Vaxx.

The patent will protect specific cancer vaccine formulations in Israel until 2027.

HER-Vaxx stimulates a polyclonal antibody response to the HER-2/neu receptor, the same biomarker targeted by the $US6.9 billion per annum drug Herceptin®.

HER-2/neu is known to be over-expressed on various tumours including gastric, breast, ovarian and pancreatic cancers.

HERVaxx has completed a Phase 1 study in breast cancer; the next stage of development will be a Phase 2 study in gastric cancer, which is the second most common cause of cancer-related death in the world

Imugene secured full rights to manufacture the cancer immunotherapy as part of its acquisition of BioLife Science in December last year.

The first patent was assigned from Pevion Biotech of Switzerland, protecting Her-Vaxx in several major markets until 2030.

Imugene also holds an exclusive global license covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

 

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Mon, 24 Mar 2014 11:46:00 -0400 https://www.proactiveinvestors.com/companies/news/156512/imugene-to-be-granted-patent-for-cancer-vaccine-in-israel-53848.html
<![CDATA[News - Imugene secures intellectual property over a proposed cancer vaccine ]]> https://www.proactiveinvestors.com/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.html Imugene (ASX: IMU) has secured full rights to manufacture the cancer immunotherapy Her-Vaxx as part of its acquisition of BioLife Science QLD, which is due to close on December 20th.

The first patent has been assigned to Biolife from Pevion Biotech of Switzerland, protecting Her-Vaxx in major markets until 2030.

Biolife has additionally been granted an exclusive global license from Pevion in the field of oncology covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.

Biloife acquired the rights to the novel cancer immunotherapy treatment platform, developed by reseach scientists at the University Medical School in Austria.

The immunotherapy induces an antibody response against breast and gastric cancers.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 19 Dec 2013 15:30:00 -0500 https://www.proactiveinvestors.com/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.html
<![CDATA[News - Imugene Limited to disclose acquisition, capital raising ]]> https://www.proactiveinvestors.com/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.html Imugene Limited (ASX: IMU) is preparing to divulge details of an acquisition, along with a capital raising.

The ASX this morning has granted the company a trading halt, with its shares placed in pre-open.

Imugene is currently focused on drug delivery technology, and is looking to commercialising these based on its novel buccal (drugs administered via the cheek) Linguet™ technology.

The halt will last until the opening of trade on Wednesday 23rd October 2013, or earlier if an announcement is made to the market.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Mon, 21 Oct 2013 12:00:00 -0400 https://www.proactiveinvestors.com/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.html
<![CDATA[News - Imugene to be granted European patent for bone loss prevention drug delivery technology ]]> https://www.proactiveinvestors.com/companies/news/156509/imugene-to-be-granted-european-patent-for-bone-loss-prevention-drug-delivery-technology-48553.html Imugene (ASX: IMU) is expected to trade higher following the company being allowed a European patent for its Linguet™ drug delivery technology.

It is significant as it protects around Linguet’s™ formulations and other specific excipients for a class of drugs that prevent the loss of bone mass.

The European Patent Office has issued an Intention to Grant Communication for Linguet™.

Linguet is now protected by the same patent in three key markets including Europe, Japan and China.

The patent is another step for Imugene on the path to commercialisation adding value to its core technology.

The next key milestone to be achieved for the company is the U.S. patent application, which would effectively provide Imugene with global coverage.

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Fri, 27 Sep 2013 15:00:00 -0400 https://www.proactiveinvestors.com/companies/news/156509/imugene-to-be-granted-european-patent-for-bone-loss-prevention-drug-delivery-technology-48553.html
<![CDATA[News - Imugene looks to melt a vitamin D in your mouth ]]> https://www.proactiveinvestors.com/companies/news/156508/imugene-looks-to-melt-a-vitamin-d-in-your-mouth-46505.html Imugene (ASX:IMU) is looking at developing a melt in the mouth vitamin D tablet after consumer research indicated there could be robust demand for such a product.

It has entered discussions to commercialise the meltlet with Australian vitamin suppliers.

Global demand for vitamins will hit the $30 billion mark by 2015 according to the company.

Imugene may be onto something as some consumers have difficulty swallowing tablets and don't like the taste of certain vitamins.

It may also find this would alleviate anxiety from younger consumers at the prospect of swallowing tablets.

 

 

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Thu, 08 Aug 2013 10:20:00 -0400 https://www.proactiveinvestors.com/companies/news/156508/imugene-looks-to-melt-a-vitamin-d-in-your-mouth-46505.html
<![CDATA[News - Imugene granted Chinese patent for drug delivery system, launches share purchase plan ]]> https://www.proactiveinvestors.com/companies/news/156507/imugene-granted-chinese-patent-for-drug-delivery-system-launches-share-purchase-plan-42620.html Imugene (ASX: IMU) has secured a key Chinese patent covering its novel drug delivery technology Linguet™ for use in the prevention of loss of bone mass, which occurs in diseases such as osteoporosis.

The technology is now protected in two key markets, with the same patent formulation allowed in Japan last month, allowing Imugene to explore two lucrative Asian markets ahead of the anticipated regulatory approval of Linguet™ Vitamin D next year.

Linguet™ enables the active ingredient of drugs to be absorbed straight into the bloodstream when placed inside the cheek (via the buccal mucosa) or under the tongue (sublingual).

The Chinese patent covers Linguet’s™ formulations and other specific excipients for a class of drugs that prevent the loss of bone mass, known as bisphosphonic acids and bisphosphonates, which are used to treat conditions such as osteoporosis and multiple myeloma.

Osteoporosis affects almost 70 million Chinese over the age of 50, including 22.5% of men and 50.1% of women.

The condition causes some 687,000 hip fractures in China, a result of the bones becoming more porous and fragile.


Vitamin D feasibility testing

Vitamin D deficiency is associated with a wide range of conditions including osteoporosis, certain forms of cancer, pre-diabetes, and cardiovascular health.

Vitamin D deficiency is a therapeutic area that has seen rapid growth in sales over the past five years, and has become one of the fastest growing nutrients worldwide.

Vitamin D sales in the U.S. have grown from $141.1 million in 2005 to $366.3 million in 2009, with CARG growth expected to be 11.2% in the U.S. between 2009 and 2014.

Imugene’s novel rapid Linguet™ form of Vitamin D has now completed feasibility testing and formulation development.

The company expects to file for regulatory approval in the UK and licence the product to a third party in 2014.


Share purchase plan

Imugene has also launched a share purchase plan offering shareholders the opportunity to subscribe for between $1,000 and $15,000 worth of new fully paid ordinary shares.

Under the share purchase plan, the offer price of each new share will be at a 10% discount to the volume weighted average price of Imugene shares traded on the ASX over the 10 consecutive trading days prior to the date new shares are to be issued – expected to be Tuesday, 4 June 2013.

The amount of capital raised will be dependent on participation in the share purchase plan, but the number of new shares issued will not exceed 30% of shares already on issue.

The funds raised will be used to advance Imugene’s lead products to regulatory filing in the UK and European Union.

Imugene has selected three priority targets – Vitamin D, pain and Parkinson’s Disease – where it can deliver improved versions of existing drugs that meet a significant unmet need.

The funds will also be used to advance development of reformulation of the over-the-counter pain drug, Ibuprofen – marketed as Nurofen® and Advil® in Australia and the UK by Reckitt Benckiser and Pfizer respectively.

While these drugs have a share of a global market of $US5.37 billion per annum, the treatments come with serious side effects such as gastric irritation and stomach ulcers, particularly when used at higher doses for extended periods of time.

Positive results from a Phase I clinical trial on a Linguet™ Ibuprofen (LC201) demonstrated that the Linguet™ drug delivery platform technology improved patient compliance and speed of action.


Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Tue, 30 Apr 2013 09:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156507/imugene-granted-chinese-patent-for-drug-delivery-system-launches-share-purchase-plan-42620.html
<![CDATA[News - Imugene focuses on developing pharmaceutical products for early revenues ]]> https://www.proactiveinvestors.com/companies/news/156506/imugene-focuses-on-developing-pharmaceutical-products-for-early-revenues-33646.html Imugene (ASX: IMU) has outlined its strategic new direction as a developer of pharmaceutical products following the recent acquisition of the Linguet™ drug delivery technology.

The company’s focus is on pushing early revenue generating products, rather than a traditional biotech platform technology that focuses on a single opportunity licensing deal far into the future.

Imugene is targeting early 2014 sale of product in Europe, specifically for the treatment of Vitamin D deficiency – a therapeutic area that has seen rapid growth in sales over the past five years, and has become one of the fastest growing nutrients worldwide.

Vitamin D sales in the U.S. have grown from $141.1 million in 2005 to $366.3 million in 2009, with CARG growth expected to be 11.2% in the U.S. between 2009 and 2014.

Vitamin D deficiency has been linked to a wide range of conditions including pre-diabetes (metabolic syndrome), osteoporosis, cardiovascular health, and Alzheimer’s. 

A significant association of Vitamin D deficiency with the rate of progress of low-risk prostate cancer is also currently being investigated.

Imugene’s strategy is to target pharmaceutical products that do not need significant clinical investment to gain regulatory approval, ensuring the most cost effective and most rapid path to market.

The Imugene Linguet product uses a specific form of Vitamin D which has been shown to be five times more effective in raising blood serum levels of Vitamin D than the usual colecalciferol form of the vitamin that has been traditionally used as a supplement.


Linguet™ technology

Linguet™ is a tablet placed under the tongue or the buccal cavity in the mouth (cheek) and allowed to dissolve releasing the active drug, which is absorbed immediately into the blood stream via the mucosa of the mouth.

The drug thereby bypasses the gastrointestinal tract and is able to reach its target more rapidly and in the process significantly lower side effects.

A key benefit of the Linguet technology is that it’s an oral delivery form with kinetics almost as fast as an injection.


Potential product pipeline

In addition to Vitamin D, over the next 12 months, a further four specific pharmaceutical product programs are scheduled for development.

The target areas selected are Parkinson’s Disease (dopamine agonist), pain (a specific NSAID), men’s health (erectile dysfunction) and status epilepticus.

Generic pharmaceutical products focusing on Parkinson’s Disease and status epilepticus are planned for release later in 2014, also in Europe initially.


Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

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Thu, 20 Sep 2012 13:50:00 -0400 https://www.proactiveinvestors.com/companies/news/156506/imugene-focuses-on-developing-pharmaceutical-products-for-early-revenues-33646.html
<![CDATA[News - Imugene readies to update market on potential acquisition, in ASX trading halt ]]> https://www.proactiveinvestors.com/companies/news/156505/imugene-readies-to-update-market-on-potential-acquisition-in-asx-trading-halt--28319.html Imugene (ASX: IMU) has been granted a trading halt by the ASX pending an announcement concerning a potential acquisition, with the company placed in pre-open.

While no further details were released, Imugene said in its recent quarterly report it continued to review new business opportunities to add value to its existing assets.

Imugene is pursuing one particular opportunity and is currently negotiating terms.

Earlier this year the company took a step back from the development of its poultry vaccines following a review of its activities.

As a result of the review, Imugene plans to focus on the components of its technology that have strong commercial prospects, in particular its pig vaccines.

The halt will last until the earlier of an announcement being made available to the market, or the opening of trade on Thursday 3 May.
 
 
 
Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums.

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Tue, 01 May 2012 14:40:00 -0400 https://www.proactiveinvestors.com/companies/news/156505/imugene-readies-to-update-market-on-potential-acquisition-in-asx-trading-halt--28319.html
<![CDATA[News - Imugene steps back from poultry vaccines ]]> https://www.proactiveinvestors.com/companies/news/156504/imugene-steps-back-from-poultry-vaccines-24036.html Imugene (ASX: IMU) has decided to place the development of poultry vaccines on hold following a review of its activities.

The company undertook a review of its portfolio of vaccine products and intellectual property after the termination of a global licence agreement with Novartis in September 2011.

As a result of the review, Imugene plans to put its focus on components of its technology that have strong commercial prospects; in particular the company’s pig vaccines.

In addition, it is considering new approaches for delivering certain vaccines in order to maximise their efficacy.

Initially, Imugene will focus on new delivery approaches for the Porcine Reproductive and Respiratory Syndrome vaccine.

The company is involved in discussions with interested parties to gauge the level of commercial interest in progressing its technology.

In addition to putting its poultry vaccines on the back burner, Imugene plans to take a prudent approach to expenditure in 2012.

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Wed, 11 Jan 2012 15:55:00 -0500 https://www.proactiveinvestors.com/companies/news/156504/imugene-steps-back-from-poultry-vaccines-24036.html
<![CDATA[News - Imugene exits trading halt with Global License Agreement announcement ]]> https://www.proactiveinvestors.com/companies/news/156503/imugene-exits-trading-halt-with-global-license-agreement-announcement-19227.html Imugene (ASX: IMU) has been released from a trading halt post the announcement that the company has received notification of termination of the global license agreement with Novartis.

The agreement was for the development and commercialisation of its vaccines for pigs and poultry.

Imugene said that the response to further enquiries regarding the decision, was that the reason for termination was “an internal decision by the licensor to discontinue investment in the development of this technology”.

The company added that no further information has been provided regarding the termination, and during the recent management visit to the U.S. operations there was no indication that termination of the venture was being considered.

Imugene added that the notice of termination is very unexpected, and that the company is disappointed with the outcome.

 

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Fri, 02 Sep 2011 14:48:00 -0400 https://www.proactiveinvestors.com/companies/news/156503/imugene-exits-trading-halt-with-global-license-agreement-announcement-19227.html
<![CDATA[News - Imugene in pre-open pending 'strategic alliance' announcement ]]> https://www.proactiveinvestors.com/companies/news/156502/imugene-in-pre-open-pending-strategic-alliance-announcement-19159.html Imugene (ASX: IMU) has been granted a trading halt by the ASX pending the release of a strategic alliance announcement, with the company's shares placed in pre-open.

The company has not yet announced any further details on the alliance, with the trading halt to remain in place until the earlier of the announcement - or the commencement of trading on Monday 5 September.

During financial year 2011 Imugene executed an agreement with an international animal health company, to commercialise Imugene's vaccines for pigs and poultry.

The Imugene business model focuses on maximising income from the receipt of research fees, license and royalties.

 

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Thu, 01 Sep 2011 10:15:00 -0400 https://www.proactiveinvestors.com/companies/news/156502/imugene-in-pre-open-pending-strategic-alliance-announcement-19159.html
<![CDATA[News - Imugene completes laboratory development of Swine Influenza Vaccines ]]> https://www.proactiveinvestors.com/companies/news/156501/imugene-completes-laboratory-development-of-swine-influenza-vaccines-2086.html Australian listed Swine flu influenza developer, Imugene (ASX: IMU) has completed the construction of vaccines for two strains of Swine Influenza.

Imugene has produced vaccines for the H1N1 and H3N2 strains. The vaccines have completed the laboratory construction phase and are ready to progress to animal trials for efficacy testing.

Commercial parameters of the Swine Influenza vaccines are now being evaluated.

The vaccines will enter the product development program if commercial parameters are satisfied.

Imugene’s Swine Influenza vaccine development program commenced in early 2008 and has identified both H1N1 and H3N2 vaccines as potential vaccines for development. Swine Influenza is a respiratory viral disease of pigs and outbreaks occur throughout many parts of the world. Vaccination against Swine Influenza is routine in many countries.

Imugene earned a net profit of $1.9 million on revenues of $3.1 million for the half year to 31 December 2008.

A strategic alliance was struck with Merial Limited agreed in December 2008.  This leverages the strength of Merial’s experience and infrastructure to the development of Imugene’s innovative range of vaccine candidates. In return for exclusivity over the Imugene technology, Imugene will receive annual payments, milestone fees and royalties.

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Mon, 27 Jul 2009 14:30:00 -0400 https://www.proactiveinvestors.com/companies/news/156501/imugene-completes-laboratory-development-of-swine-influenza-vaccines-2086.html