Catalent and Humanigen, Inc. announced the expansion of their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
Catalent is the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply solutions for drugs, biologics, cell and gene therapies and consumer health products. Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s lead therapeutic candidate.
Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase 3 study is currently underway evaluating hospitalized COVID-19 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,” commented Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “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 has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” commented Karen Flynn, President of Catalent Biologics and Chief Commercial Officer. “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.”
To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen’s ongoing clinical trials across various disease categories. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase 3 potential registration study in COVID-19 from its Philadelphia facility.
Lenzilumab was originally manufactured in Catalent’s Madison facility using Catalent Biologics’ proprietary GPEx® cell line development technology. As part of the expanded partnership, Catalent intends to provide additional drug substance clinical supply for Humanigen’s clinical trials, Expanded Access Program (EAP), as well as additional late-stage development and clinical and potential commercial drug substance manufacturing and vial filling at its Madison and Bloomington, Indiana, sites.
Catalent Biologics’ Madison facility provides development and drug substance manufacturing, including GPEx cell line development, process development, process validation, formulation development, and clinical and commercial cGMP manufacturing. Its Bloomington facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.
Catalent’s OneBio Suite is an integrated solution for the development, manufacturing, and supply of biologic drugs. Launched in May 2019, the suite of offerings is designed to integrate activities and accelerate timelines, reduce risk and simplify development with a single contract, program manager, and development timeline from cell line development to supply, with harmonized quality systems.