(RTTNews) - Catalent Biologics and Humanigen, Inc. (HGEN) announced Thursday 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.
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.
Humanigen's expansion of relationship with Catalent was based on lenzilumab's promising clinical data to solidify its ability to manufacture and supply lenzilumab. Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials.
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.
To date, Catalent 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.
Lenzilumab was originally manufactured in Catalent's Madison facility using Catalent's 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.
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