Avid Bioservices, Inc. and Humanigen, Inc. announced that they have entered into a manufacturing services agreement to expand production capacity for lenzilumab™, Humanigen’s therapeutic candidate in development for COVID-19. Lenzilumab is an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody designed to prevent and treat an immune hyper-response called “cytokine storm” associated with COVID-19. Humanigen has completed enrollment of its 520 patient Phase 3 clinical trial of lenzilumab in hospitalized COVID-19 patients.
Under the terms of this Current Good Manufacturing Practice (cGMP) agreement, Avid will initiate technical transfer and analytical validation activities for lenzilumab with the goal of delivering cGMP drug substance batches to support Humanigen’s regulatory and potential commercial activities. This collaboration enhances commercial production efforts for lenzilumab in advance of potential filings for emergency use authorization (EUA) and subsequent Biologics License Application (BLA) later this year.
“Having recently completed enrollment in our Phase 3 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, MBA, chief executive officer of Humanigen.
“As the COVID-19 pandemic continues to rage in the U.S. 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. “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.”
About Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and cGMP manufacturing of biopharmaceutical drug substances derived from mammalian cell culture. The company provides a comprehensive range of process development, cGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 28 years of experience producing monoclonal antibodies and recombinant proteins, Avid’s services include cGMP clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing and regulatory submissions support. For early-stage programs the company provides a variety of process development activities, including upstream and downstream development and optimization, analytical methods development, testing and characterization. The scope of our services ranges from standalone process development projects to full development and manufacturing programs through commercialization.
About Humanigen, Inc.
Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. Humanigen believes that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. Humanigen’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. Humanigen is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, Humanigen is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. Humanigen is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.