Humanigen showing positive results for cancer drug lenzilumab, also used to treat patients hospitalized with coronavirus
Humanigen Inc (NASDAQ: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.
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.
It has also initiated a Phase 3 clinical trial to evaluate lenzilumab combined with remdesivir vs. remdesivir alone as a treatment for severe coronavirus (COVID-19) patients.
Humanigen is also looking at two other drug candidates: ifabotuzumab and HGEN005.