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The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.
On Feb. 3, 2021, Avid Bioservices, a contract development and manufacturing organization (CDMO), and Humanigen announced that they have entered into a current good manufacturing practice (CGMP) manufacturing services agreement to expand production capacity for lenzilumab, Humanigen’s therapeutic candidate in development for COVID-19.
Under the agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the aim of delivering CGMP drug substance batches to support Humanigen’s regulatory and potential commercial activities. The collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization (EUA) and subsequent biologics license application later this year, Humanigen stated in a company press release.
Lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM–CSF) monoclonal antibody, is designed to prevent and treat an immune hyper-response called “cytokine storm” associated with COVID-19. Humanigen has completed enrollment of a 520-patient Phase III clinical trial in hospitalized COVID-19 patients.
“Having recently completed enrollment in our Phase [III] clinical trial of lenzilumab, we are also focusing on scalable manufacturing capacity to help ensure access in advance of a potential EUA filing,” said Cameron Durrant, MD, CEO of Humanigen, in the press release.
“As the COVID-19 pandemic continues to rage in the [United States] and around the world, it is essential that life science companies like Avid and Humanigen align our areas of expertise to speed the development and commercialization of valuable therapeutics that can make a difference in the lives of patients. At Avid, we are proud to play our part in these important efforts,” said Timothy Compton, chief commercial officer of Avid, in the press release. “Lenzilumab is an exciting COVID-19 therapeutic candidate and the type of complex biologic for which Avid possesses decades of manufacturing success. We are pleased to be trusted by Humanigen to provide the critical CDMO services that will be essential for achieving the company’s regulatory and commercialization goals for lenzilumab.”