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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