November 6, 2020 -- Humanigen is working with the Department of Defense (DOD) to advance its lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody (mAb) ahead of a potential emergency use authorization (EUA) to treat COVID-19.
The cooperative research and development agreement with the DOD's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense originates from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Department of Health and Human Services (HHS). The agreement supports Operation Warp Speed.
The collaboration means Humanigen will be provided with access to a full-scale, integrated team of Operation Warp Speed manufacturing and regulatory subject matter experts, decision-makers, and statistical support in anticipation of applying for an EUA and subsequently a biologics license application (BLA) for lenzilumab.
The drug is designed to prevent and treat an immune hyper-response, a complication considered to be a leading cause of COVID-19 death. In fact, lenzilumab was selected by the National Institutes of Health as a possible treatment for COVID-19 in the Accelerating COVID-19 Therapeutic Innovations and Vaccines (ACTIV)-5 Big Effect Trial (ACTIV-5/BET), which will enroll patients at up to 40 sites in the U.S.