Humanigen, DOD develop COVID-19 mAb

By The Science Advisory Board staff writers

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.

Ajinomoto to manufacture COVID-19 drug for Humanigen
Biopharmaceutical contract development and manufacturing firm Ajinomoto has entered into an agreement with Humanigen for the fill-finish supply of lenzilumab....

Copyright © 2020

Microscopy and Microanalysis Meeting
July 31 - August 4
Portland, Oregon United States
Glasgow International Health Festival
August 24-27
Glasgow, Glasgow City United Kingdom
Pharma Competitive Intelligence Conference and Exhibition
September 21-22
Newark, New Jersey United States
BioProcess International (BPI) Conference
September 27-30
Boston, Massachusetts United States
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter