BURLINGAME, Calif.– Humanigen, Inc. (Nasdaq:HGEN) (“Humanigen”), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab™, and Chime Biologics (“Chime”), a world-class contract development and manufacturing organization (CDMO), today announced that they have entered into a manufacturing services agreement to produce lenzilumab bulk drug substance and drug product for Humanigen for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the United States including Europe, the United Kingdom, India and Brazil.
“With the recent announcement of the results from the LIVE-AIR Phase 3 clinical trial of lenzilumab, we are pleased to enter into a partnership with Chime to help with our anticipated commercial production of lenzilumab,” said Cameron Durrant, MD, MBA, chief executive officer of Humanigen. “Following a competitive process focused on quality, technical abilities, supply chain and economic criteria we selected Chime as our first foreign CDMO to supply lenzilumab to ex-US markets.”
Under the terms of this agreement, Chime will use the state-of-the-art modular single use KuBio (Cytiva) biologics facility in China. The cell culture capacity at the facility is 24,000L with planned expansion to 140,000L and Chime would be willing to commit at least 56,000L for Humanigen manufacture annually. Technical transfer work has already begun, and commercial product is planned to be available in 2022.
“We are pleased to have been selected by Humanigen as a manufacturing partner for ex-US supply of lenzilumab. Since 2013, Chime Biologics has developed and produced more than 30 products and supplied to over 20 countries from its latest generation single use facility. We are proud of our record for quality, compliance, bioprocessing expertise, and cost effectiveness, and very much look forward to supporting Humanigen in this important program,” said Dr. John Zeng, CEO of Chime Biologics.
