CPhI Online

- Research & Development

Humanigen expands partnership with Catalent to manufacture investigational COVID-19 therapeutic candidate

20 Jul 2020

Data on the first clinical use of lenzilumab in patients with severe COVID-19 pneumonia suggest promising results.

Catalent and Humanigen have expanded 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 III study is currently underway evaluating hospitalized COVID-19 patients.

Cameron Durrant, CEO of Humanigen said that if they can secure FDA approvals or Emergency Use Authorization, this expanded partnership with Catalent Biologics will "accelerate our ability to get this therapy to patients that need it most”.

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.

As part of the expanded partnership, Catalent will 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 is also providing clinical supply support for Humanigen’s Phase III potential registration study in COVID-19 from its Philadelphia facility. Humanigen is a clinical-stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s lead therapeutic candidate.