February 3, 2021 -- Contract development and manufacturing organization Avid Bioservices and Humanigen have entered into a manufacturing services agreement to expand production capacity for lenzilumab, Humanigen's COVID-19 therapeutic candidate.
Lenzilumab is an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat cytokine storm associated with COVID-19. The candidate is currently in a phase III clinical trial in hospitalized COVID-19 patients.
Under the agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering current good manufacturing practice (cGMP) drug substance batches to support Humanigen's regulatory and potential commercial activities.
The agreement supports Humanigen's commercialization efforts for lenzilumab in advance of potential filings for emergency use authorization and a subsequent biologics license application later this year.