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Humanigen Inc: DEEP DIVE

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

A goal is to improve the safety of CAR-T therapies, used in the treatment of children with acute lymphoblastic leukemia and adults with advanced lymphomas
Cameron Durrant
OVERVIEW: HGEN The Big Picture
Cameron Durrant has been at the helm of Humanigen for the past three years

• 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 [email protected]

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