Humanigen expands partnership with BARDA for COVID-19 mAb manufacturing

By The Science Advisory Board staff writers

Humanigen has expanded its cooperative research and development agreement with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense to gain access to manufacturing capacity reserved by the Biomedical Advanced Research and Development Authority (BARDA). The agreement supports the development of the monoclonal antibody (mAb) lenzilumab in advance of a potential emergency use authorization (EUA) for COVID-19.

Lenzilumab is the company's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody that is designed to prevent and treat cytokine storm, a complication of COVID-19. The company is currently conducting a phase III clinical trial of lenzilumab as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-5 National Institutes of Health initiative.

The amended agreement, which is co-signed by BARDA, provides the company with access to manufacturing space for fill-finish processes to accelerate the drug product manufacturing of lenzilumab. The initial agreement, originally signed in November 2020 provides Humanigen with access to a full-scale, integrated team of manufacturing and regulatory subject matter experts and statistical support in anticipation of applying for an EUA and subsequent biologics license agreement for lenzilumab as a potential treatment for COVID-19.

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