Proactiveinvestors USA & Canada Humanigen Inc https://www.proactiveinvestors.com Proactiveinvestors USA & Canada Humanigen Inc RSS feed en Wed, 19 Jun 2019 17:52:07 -0400 http://blogs.law.harvard.edu/tech/rss Genera CMS action@proactiveinvestors.com (Proactiveinvestors) action@proactiveinvestors.com (Proactiveinvestors) <![CDATA[Media files - Humanigen teams up with Kite to treat a type of lymphoma cancer ]]> https://www.proactiveinvestors.com/companies/stocktube/13685/humanigen-teams-up-with-kite-to-treat-a-type-of-lymphoma-cancer-13685.html Mon, 10 Jun 2019 14:13:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/13685/humanigen-teams-up-with-kite-to-treat-a-type-of-lymphoma-cancer-13685.html <![CDATA[News - Humanigen and Gilead's Kite to work on study to evaluate Yescarta with lenzilumab to treat a type of lymphoma ]]> https://www.proactiveinvestors.com/companies/news/221315/humanigen-and-gilead-s-kite-to-work-on-study-to-evaluate-yescarta-with-lenzilumab-to-treat-a-type-of-lymphoma-221315.html Humanigen Inc (OTCMKTS:HGEN) said Friday that it has forged a clinical collaboration with Kite, a company belonging to Gilead Sciences Inc (Nasdaq:GILD), to study its flagship therapy lenzilumab, with Yescarta in patients with relapsed diffuse large B-cell lymphoma (DLBCL).

An aggressive tumor develops in the first signs of DLBCL when a type of white blood cell starts to divide in an uncontrolled way. DLBCL is the most common type of non-Hodgkin lymphoma.

Burlingame, California-based Humanigen's key drug candidate lenzilumab, is a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells. Lenzilumab improves the effectiveness of CAR-T, a new approach to cancer therapy involving altered T cells.

READ: Humanigen pins hopes on monoclonal antibody treatment of cancer therapy's side effects

Yescarta, developed by California-based Kite was the first CAR-T cell therapy to be approved by the US Food and Drug Administration for the treatment of adult patients with relapsed large B-cell lymphoma after two or more lines of systemic therapy.

The objective of the Phase 1/2 study is to determine the effect of lenzilumab on the safety of Yescarta (axicabtagene ciloleucel) in patients with relapsed diffuse large B-cell lymphoma (DLBCL).

Kite will act as the sponsor of the study

“CAR T therapy represents a significant advance in the way relapsed or refractory large B-cell lymphoma is treated,” said John McHutchison, chief scientific officer, at Gilead. “As leaders in cell therapy, we are committed to pursuing clinical and preclinical strategies aimed at improving the efficacy and safety of CAR-T therapy. We look forward to this clinical collaboration with Humanigen and to evaluating the combination of lenzilumab and Yescarta in our clinical trial.”

Pre-clinical work involving mice shows lenzilumab is effective in preventing side effects associated with cancer therapies involving altered T cells.

“Humanigen has pioneered the approach to neutralizing GM-CSF to improve CAR-T,” said Humanigen CEO Cameron Durrant. “This collaboration with Kite will help validate the work Humanigen has done in understanding the pathophysiology of the inflammatory cascade as well as the potential role GM-CSF plays in influencing CAR-T cell treatment outcomes.”

Contact Uttara Choudhury at uttara@proactiveinvestors.com

Follow her on Twitter: @UttaraProactive

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Fri, 31 May 2019 09:35:00 -0400 https://www.proactiveinvestors.com/companies/news/221315/humanigen-and-gilead-s-kite-to-work-on-study-to-evaluate-yescarta-with-lenzilumab-to-treat-a-type-of-lymphoma-221315.html
<![CDATA[News - Humanigen's therapy to reduce cancer-treatment side effects highlighted in premier hematology journal ]]> https://www.proactiveinvestors.com/companies/news/220527/humanigen-s-therapy-to-reduce-cancer-treatment-side-effects-highlighted-in-premier-hematology-journal-220527.html Humanigen Inc (OTCMKTS:HGEN) announced Friday that the official journal of the American Society of Hematology, known simply as "blood", has published an article highlighting a drug therapy the company is developing that’s designed to reduce dangerous side effects of a cancer treatment involving altered T cells.

The company said the article by Omar Ahmed entitled “CAR-T Cell Neurotoxicity: Hope is on the Horizon” was published on May 16 in blood, which is is widely regarded as a premier journal in hematology. Ahmed is Humanigen's vice president of portfolio strategy, clinical, medical and scientic affairs.

Humanigen, which is based in Burlingame, California, said the article puts the spotlight on the unmet need to mitigate T cell (CAR-T)-induced neurotoxicity using GM-CSF neutralization therapy.

READ: Humanigen unveils promising results from Ifabotuzumab Phase I study

“GM-CSF neutralization could be a next-generation strategy to potentially improve the efficacy, safety, and cost-effectiveness of CAR-T therapy,” said Humanigen CEO Cameron Durrant.

The company is developing monoclonal antibodies to improve CAR-T cancer therapies and oncology treatments. Its key drug candidate is lenzilumab, a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects.

Humanigen said the article highlighted the potential of GM-CSF:

Severe neurotoxicity is a negative prognostic factor for overall survival with chimeric antigen receptor T-cell (CAR-T) therapy. Prolonged exposure of corticosteroids for severe neurotoxicity may negatively influence overall survival. GM-CSF neutralization identified as a potential next-generation strategy to reduce CAR-T induced neurotoxicity while simultaneously improving the efficacy and durability of the response.

Humanigen's stock recently traded down 4.4% to $1.09 a share on the OTC markets.

Contact the author: patrick@proactiveinvestors.com

Follow him on Twitter @PatrickMGraham

 

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Fri, 17 May 2019 09:28:00 -0400 https://www.proactiveinvestors.com/companies/news/220527/humanigen-s-therapy-to-reduce-cancer-treatment-side-effects-highlighted-in-premier-hematology-journal-220527.html
<![CDATA[News - Humanigen unveils promising results from Ifabotuzumab Phase I study at the American Association for Cancer Research's annual meeting ]]> https://www.proactiveinvestors.com/companies/news/217658/humanigen-unveils-promising-results-from-ifabotuzumab-phase-i-study-at-the-american-association-for-cancer-research-s-annual-meeting-217658.html Humanigen (OTCMKTS:HGEN) told investors Monday that the promising preliminary results from a Phase 1 trial evaluating its flagship cancer treatment ifabotuzumab in patients with recurrent brain cancer will be showcased at the American Association for Cancer Research’s annual meeting in Atlanta, Georgia (March 29-April 3).

Its Phase 1 study shows the potential of this anti-EphA3 monoclonal antibody to attack tumors by killing the stromal cells that protect them and the vasculature that feeds them without killing normal cells. 

Indeed, ifabotuzumab’s impact on tumor vasculature provides evidence that targeting EphA3-expressing tumor neovasculature is a viable therapy for fighting solid tumors.

READ: Humanigen pins hopes on monoclonal antibody treatment of cancer therapy's side effects

EphA3 is a tumor-restricted antigen expressed in the tumor vasculature of aggressive brain cancers. It also surfaces in the tumor vasculature and tumor stroma of colon, lung, kidney and bladder tumors, as well as melanoma.

“By specifically targeting the tumor stem cells, stromal cells and neovasculature, we believe ifabotuzumab has the potential to emerge as a next-generation oncology therapy for a range of solid tumors,” said Dr. Cameron Durrant, CEO of Humanigen, in a statement.

READ: Humanigen CEO optimistic on drug candidate after pulling company from the brink

Research for the Phase 1 study was led by Drs Andrew Scott and Hui Gan of the Olivia Newton-John Cancer Research Institute in Heidelberg, Victoria, Australia. And its preliminary results include data from four patients who have been enrolled so far.

As part of the trial, positron emission tomography (PET) imaging showed that ifabotuzumab accumulated at the site of the tumor in all patients treated and didn’t affect normal brain tissue.

The preliminary results are consistent with a preclinical study published recently in the journal ‘Cancers’ by doctors Bryan Day & Andrew Boyd from the QIMR Berghofer Medical Research Institute in Brisbane, Australia, in which they showed that the EphA3 receptor is an attractive tumor-specific target for tumors of the brain and other solid cancers.

Humanigen, which is based in Burlingame, California, is developing monoclonal antibodies to improve CAR-T cancer therapies and oncology treatments. Its key drug candidate is lenzilumab, a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects.

Humanigen shares closed at $1.35 on Friday.

Contact Ellen Kelleher at ellen@proactiveinvestors.com

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Mon, 01 Apr 2019 09:14:00 -0400 https://www.proactiveinvestors.com/companies/news/217658/humanigen-unveils-promising-results-from-ifabotuzumab-phase-i-study-at-the-american-association-for-cancer-research-s-annual-meeting-217658.html
<![CDATA[Media files - Humanigen's new data show increase in mice survival with lenzilumab ]]> https://www.proactiveinvestors.com/companies/stocktube/12772/humanigen-s-new-data-show-increase-in-mice-survival-with-lenzilumab-12772.html Thu, 28 Mar 2019 12:56:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/12772/humanigen-s-new-data-show-increase-in-mice-survival-with-lenzilumab-12772.html <![CDATA[News - Humanigen presents new study showing lenzilumab's potential to fight tumors ]]> https://www.proactiveinvestors.com/companies/news/217031/humanigen-presents-new-study-showing-lenzilumab-s-potential-to-fight-tumors-217031.html Humanigen (OTCMKTS:HGEN) this week announced favourable data from a new study evaluating lenzilumab, its flagship therapy, which improves the effectiveness of CAR-T, a new approach to cancer therapy involving altered T cells.

Lenzilumab, the key drug candidate for the Burlingame, California, company is a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects.

The results of the new study suggest that the use of lenzilumab in combination with CAR-T therapy for the treatment of lymphoblastic leukemia triggered improved anti-tumor activity and  a marked improvement in the control of the leukemia sustained for at least 35 days post CART19 infusion compared to CART19 plus a control.

READ: Humanigen pins hopes on monoclonal antibody treatment of cancer therapy's side effects

The improvement in overall survival rates also came with so-called GM-CSF neutralization, which suggests this factor plays a role in improving CART 19 therapy.

In a statement, Dr. Cameron Durrant, CEO of Humanigen, said: “These results suggest that GM-CSF neutralization would improve the efficacy and toxicity profile of current CAR-T therapies and opens the possibility for other combinations with agents that might further improve efficacy but would be too toxic if used in the absence of GM-CSF neutralization.”

The use of lenzilumab also prevented cases of cytokine release syndrome, which can include fever, nausea, headache, rash, rapid heartbeat, low blood pressure and trouble breathing. It also triggered a reduction in neuroinflammation as well as an increase in CAR-T cell expansion.

READ: Humanigen CEO optimistic on drug candidate after pulling company from the brink

The study was conducted in mice and used human acute lymphoblastic leukemia as well as human-targeted Car-T therapy.

Further phase Ib/II trials of lenzilumab in combination with CART19 therapies are expected to get underway in the coming months.

Humanigen shares closed at $1.35 on Thursday.

Contact Ellen Kelleher: ellen@proactiveinvestor.com ]]>
Fri, 22 Mar 2019 08:15:00 -0400 https://www.proactiveinvestors.com/companies/news/217031/humanigen-presents-new-study-showing-lenzilumab-s-potential-to-fight-tumors-217031.html
<![CDATA[News - Humanigen CEO optimistic on drug candidate after pulling company from the brink ]]> https://www.proactiveinvestors.com/companies/news/215649/humanigen-ceo-optimistic-on-drug-candidate-after-pulling-company-from-the-brink-215649.html Almost three and a half years ago, Cameron Durrant made one of those pivotal decisions that executives face perhaps once or twice in their careers.

Several colleagues had called him about taking the reins of Humanigen Inc (OTCMKTS:HGEN), a company that’s now getting into the clinic to reduce the sometimes fatal and dangerous side effects of CAR-T, a new approach to cancer therapy involving altered T cells.

But there were a few twists. The company had filed for bankruptcy, with slim prospects of getting out. It had been delisted from the Nasdaq, was facing multiple class-action lawsuits, and its drug pipeline was in disarray. The little money the company had would probably be spent on the bankruptcy and legal actions. The board had imploded.

READ: Humanigen study of its monoclonal antibody in CAR-T therapy featured in medical journal

“The company was in pretty dire straits,” Durrant told Proactive Investors.

Durrant consulted with family and industry colleagues and joined the board in January 2016, effectively working as the CEO, a role he officially took in March 2016.

An enticement, according to Durrant, was the Burlingame, California, company’s stable of drug candidates.

Prior work for the turnaround specialist includes serving as CEO at three specialty pharma companies and in senior executive roles at Pharmacia Corp, now part of Pfizer Inc (NYSE:PFE), as well as Johnson & Johnson (NYSE: JNJ).

Humanigen emerged from bankruptcy in June 2016, but it had another setback when it was beaten to approval by a competitor that won Food and Drug Administration approval in August 2017 for benznidazole, a treatment of Chagas disease, a tropical, parasitic illness.

Focus on lenzilumab

Since then, the company has concentrated on its main drug candidate, lenzilumab. It’s a recombinant monoclonal antibody designed to treat side effects associated with CAR-T therapies used in the treatment of children with acute lymphoblastic leukemia and adults with advanced lymphomas. The side effects include fever, heartbeat irregularities, low blood pressure, organ failure, seizures, coma, brain swelling and sometimes death.

Lenzilumab, according to Humanigen, shows promise in neutralizing a substance that was previously thought to promote growth of white blood cells but is actually tied to inflammatory processes that can occur during CAR-T therapies and lead to the side effects. Pre-clinical work has shown lenzilumab is effective in preventing the side effects and may make the CAR-T therapies more effective, according to the company.

Durrant is optimistic about the company’s prospects as he steps up fundraising and hunts for partnerships and deals.

“We have additional investors who are willing to pony up,” he said, “As well as considerable proactive outreach from potential pharms partners and leading key opinion leaders and clinicians in the field. We think we can make some great things happen.”

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Tue, 05 Mar 2019 14:15:00 -0500 https://www.proactiveinvestors.com/companies/news/215649/humanigen-ceo-optimistic-on-drug-candidate-after-pulling-company-from-the-brink-215649.html
<![CDATA[News - Humanigen pins hopes on monoclonal antibody treatment of cancer therapy's side effects ]]> https://www.proactiveinvestors.com/companies/news/215256/humanigen-pins-hopes-on-monoclonal-antibody-treatment-of-cancer-therapy-s-side-effects-215256.html • The company's key drug candidate is lenzilumab, a recombinant monoclonal antibody
• Pre-clinical work involving mice shows it's is effective in preventing side effects associated with a cancer therapy involving altered T cells, according to Humanigen
• Patients include children with acute lymphoblastic leukemia and adults with advanced lymphomas
• Cameron Durrant, a medical doctor and MBA, assumed the role of CEO in March 2016; prior work includes serving as head of three specialty pharma companies
• The Burlingame, California-based company is optimistic that it can soon add to $1 million in cash

What is Humaningen’s focus?

Humanigen Inc (OTCMKTS:HGEN) is in the early stages of work on a drug designed to reduce the sometimes dangerous side effects associated with a cancer therapy involving altered T cells.

A goal is to improve the safety of so-called CAR-T therapies, used in the treatment of children with acute lymphoblastic leukemia and adults with advanced lymphomas. A frequent side-effect is cytokine release syndrome, which can include fever, nausea, headache, rash, rapid heartbeat, low blood pressure and trouble breathing. Reactions are often mild but occasionally life-threatening.

What are Humaningen’s products?

The key drug candidate for the Burlingame, California, company is lenzilumab, a recombinant monoclonal antibody that neutralizes a substance that promotes growth of white blood cells but is also tied to inflammations that can occur during CAR-T therapies and lead to side effects. Pre-clinical work involving mice shows lenzilumab is effective in preventing the side effects and may make the CAR-T therapies more effective, according to Humanigen.

The company has completed a Phase 1 clinical trial of patients with a type of leukemia conducted to identify the recommended Phase 2 dose of lenzilumab and to assess its safety. The company is planning on starting pivotal studies this year involving CAR-T and hopes to complete them by the end of 2020.

Humanigen is also looking at two other drug candidates: ifabotuzumab and HGEN005.

Ifabotuzumab, according to Humanigen, shows potential in attacking tumors by killing the stromal cells that protect them and the vasculature that feeds them without killing normal cells. The company says the first patients have been dosed in a Phase 1 trial at the Olivia Newton-John Cancer Research Institute in Australia to assess safety.

The company’s other drug candidate, HGEN005, shows promise as a treatment for eosinophilia, a condition in which the number of eosinophil white blood cells is greatly increased. It can be a sign of a parasitic infection, an allergic reaction or cancer. Humanigen is talking with a leading US cancer center about pre-clinical testing in eosinophilic leukemia.

Inflection points

Founded in 2000 as KaloBios Pharmaceuticals Inc, the company has undergone significant twists and turns in the past several years.

In 2015, Martin Shkreli bought a stake in the company and briefly served as its CEO until his arrest on charges of securities fraud related to another company that had no connection to Humanigen. As head of that company, he gained notoriety for raising the price of an AIDS drug by more than 50 times.

With Shkreli gone, Humanigen filed for Chapter 11 bankruptcy protection, emerging in June 2016. It had another setback the following year when it was unsuccessful in winning FDA approval for benznidazole, a treatment of Chagas disease, a tropical, parasitic illness.

Under Cameron Durrant, a medical doctor and MBA who assumed the role of CEO in March 2016, the company has concentrated on realizing the promise of lenzilumab. Prior work for the turnaround specialist includes serving as CEO at three specialty pharma companies and senior executive roles at Pharmacia Corp, now part of Pfizer Inc (NYSE:PFE), as well Johnson & Johnson (NYSE: JNJ).

Durrant told Proactive Investors that he is optimistic about adding to the company's $1 million in cash, which is enough to operate for about three months. 

“We have additional investors who are willing to pony up,” Durrant said.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Mon, 25 Feb 2019 15:28:00 -0500 https://www.proactiveinvestors.com/companies/news/215256/humanigen-pins-hopes-on-monoclonal-antibody-treatment-of-cancer-therapy-s-side-effects-215256.html
<![CDATA[News - Humanigen study of monoclonal antibody in CAR-T therapy presented at Houston conference ]]> https://www.proactiveinvestors.com/companies/news/215241/humanigen-study-of-monoclonal-antibody-in-car-t-therapy-presented-at-houston-conference-215241.html Humanigen Inc (OTCMKTS:HGEN) said Monday that final results of a study on the use of GM-CSF neutralization in CAR-T therapy was presented last week at an annual meeting in Houston.

The Burlingame, California, company said in a statement that Rosalie Sterner presented results of the study on behalf of Dr Saad Kenderian and a research team at Mayo Clinic in  Rochester, Minnesota.

READ: Humanigen study of its monoclonal antibody in CAR-T therapy featured in medical journal

The study was conducted using lenzilumab, the company’s anti-GM-CSF (granulocyte-macrophage colony-stimulating factor) monoclonal antibody, and was recently featured on the cover of the February 14 edition of "blood", the journal of the American Society of Hematology.

The biotech’s lenzilumab monoclonal antibody is designed to reduce the sometimes dangerous side-effects associated with a cancer therapy involving altered T cells. 

Lenzilumab, used in combination with CAR-T therapy, prevents the onset of cytokine release syndrome and significantly reduces neuroinflammation, may prevent impairment of the blood-brain barrier and significantly reduces the neuroinflammation caused by CAR-T, according to Humanigen.

The team found that the therapy enhanced antitumor activity, improved overall survival and improved durability of response with a reduced rate of relapse observed with GM-CSF neutralization.

Shares of Humanigen were down $0.12 to $1.24 in Friday’s OTC Markets trading.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com
 

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Mon, 25 Feb 2019 09:19:00 -0500 https://www.proactiveinvestors.com/companies/news/215241/humanigen-study-of-monoclonal-antibody-in-car-t-therapy-presented-at-houston-conference-215241.html
<![CDATA[News - Humanigen study of its monoclonal antibody in CAR-T therapy featured in medical journal ]]> https://www.proactiveinvestors.com/companies/news/214733/humanigen-study-of-its-monoclonal-antibody-in-car-t-therapy-featured-in-medical-journal-214733.html Humanigen Inc (OTCMKTS:HGEN) said  Friday that the editors of the medical journal blood featured on the cover of the current edition, a study of the use of the company's proprietary monoclonal antibody.

The biotech’s lenzilumab monoclonal antibody is designed to reduce the sometimes dangerous side-effects associated with a cancer therapy involving altered T cells. The study involving lenzilumab showed a reduction in cytokine release syndrome and neuroinflammation as well as an enhancement in CAR-T cell function, according to the Burlingame, California, company.

READ: Sonavex to begin commercial roll-out of its blood clot detection device Q1 2019

The study, conducted with lab mice, was designed to replicate the effects seen in CAR-T clinical trials. It used human acute lymphoblastic leukemia cells, human CD19 targeted CAR-T (CART19) cells and human peripheral blood mononuclear cells.

The use of lenzilumab with CART19 therapy resulted in significant improvement in leukemic disease control, sustained for at least 35 days after CART19 administration, compared with a control, according to Humanigen.  

“This work represents a significant advance in understanding how to improve efficacy and safety of CAR-T,” Dr Cameron Durrant, CEO of Humanigen, said in a statement.

Shares of the company rose 1.1% to $0.93 in Thursday’s OTC Markets trading.

Contact Dennis Fitzgerald at dennis@proactiveinvestors.com

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Fri, 15 Feb 2019 08:58:00 -0500 https://www.proactiveinvestors.com/companies/news/214733/humanigen-study-of-its-monoclonal-antibody-in-car-t-therapy-featured-in-medical-journal-214733.html
<![CDATA[Media files - Humanigen has gleaned 'significant' interest from potential partners from its data presentation ]]> https://www.proactiveinvestors.com/companies/stocktube/12185/humanigen-has-gleaned--significant--interest-from-potential-partners-from-its-data-presentation-12185.html Mon, 11 Feb 2019 07:52:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/12185/humanigen-has-gleaned--significant--interest-from-potential-partners-from-its-data-presentation-12185.html <![CDATA[Media files - Humanigen new research shows encouraging results for cancer treatment using Car-T ]]> https://www.proactiveinvestors.com/companies/stocktube/11475/humanigen-new-research-shows-encouraging-results-for-cancer-treatment-using-car-t-11475.html Wed, 05 Dec 2018 15:53:00 -0500 https://www.proactiveinvestors.com/companies/stocktube/11475/humanigen-new-research-shows-encouraging-results-for-cancer-treatment-using-car-t-11475.html <![CDATA[Media files - Humanigen CEO says company is developing drug to make 'the new frontier' in cancer therapy safer ]]> https://www.proactiveinvestors.com/companies/stocktube/9440/humanigen-ceo-says-company-is-developing-drug-to-make-the-new-frontier-in-cancer-therapy-safer-9440.html Sat, 09 Jun 2018 01:32:00 -0400 https://www.proactiveinvestors.com/companies/stocktube/9440/humanigen-ceo-says-company-is-developing-drug-to-make-the-new-frontier-in-cancer-therapy-safer-9440.html