Humanigen Inc (OTC:HGEN) and Catalent Biologics have expanded their partnership, which sees Catalent provide development, manufacturing and commercialization services for Humanigen’s drug lenzilumab, the companies announced Thursday.
The Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical coronavirus (COVID-19) related pneumonia, the majority of whom showed rapid recovery and hospital discharge, the company said. A Phase 3 study is currently underway evaluating hospitalized coronavirus patients.
"Based on lenzilumab’s promising clinical data, we are pleased to expand our relationship with Catalent to solidify our ability to manufacture and supply lenzilumab," Humanigen CEO Cameron Durrant said in a statement. "If we are able to secure FDA approvals or Emergency Use Authorization, Catalent Biologics’ deep expertise and integrated OneBio solution will accelerate our ability to get this therapy to patients that need it most."
Catalent Biologics has delivered early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin. Under the expanded partnership, Catalent will also provide clinical supply support for Humanigen’s Phase 3 potential registration study of COVID-19 from its Philadelphia facility.
The company’s OneBio Suite is an integrated solution for the development, manufacturing and supply of biologic drugs. The suite of offerings is designed to accelerate timelines, reduce risk and simplify development.
“Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” Catalent CCO Karen Flynn said. “The experience we already have with lenzilumab, and our OneBio integrated offering from development to supply, make Catalent uniquely suited to support Humanigen in the journey to make this promising therapy available to Covid-19 patients as soon as possible following receipt of regulatory approvals.”
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