Catalent and Humanigen, Inc. have expanded their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.
Recent data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, showed the majority had rapid recovery and hospital discharge. A Phase III study is currently underway evaluating hospitalized COVID-19 patients.
To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, WI to support Humanigen’s ongoing clinical trials across various diseases. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase III 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, IN, sites.
