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Imugene meets heavy demand in capital raising for HER-Vaxx

Imugene meets heavy demand in capital raising for HER-Vaxx

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.

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Imugene Ltd Timeline

Newswire
September 07 2015

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