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www.fdanews.com/articles/199250-thermo-fisher-to-help-manufacture-humanigens-covid-19-therapeutic-lenzilumab

Thermo Fisher to Help Manufacture Humanigen’s COVID-19 Therapeutic Lenzilumab

September 25, 2020

Humanigen has teamed up with Massachusetts-based Thermo Fisher Scientific, which will help manufacture the drug substance for Humanigen’s COVID-19 monoclonal antibody lenzilumab.

The partnership is intended to scale up commercial production efforts in advance of a potential Emergency Use Authorization from the FDA in 2020 and a subsequent approval. Thermo Fischer expects to begin commercial-scale production of the lenzilumab bulk drug substance before the end of the year.

The drugmaker has previously partnered with Swiss-based Lonza and New Jersey-based Catalent and it expects commercial scale production to begin before year’s end.

Lenzilimab is currently in phase 3 testing in the U.S. and Brazil as a COVID-19 treatment. It is also in a separate National Institutes of Health study in combination with remdesivir for hospitalized COVID-19 patients (DID, Aug. 11).

Other drugmakers have been entering manufacturing deals for COVID-19 monoclonal antibodies. Last week, Eli Lilly and Amgen entered into a global partnership to increase supply of Eli Lilly’s neutralizing antibodies (DID, Sept. 18). And last month, Regeneron Pharmaceuticals and Roche teamed up to increase production of Regeneron’s REGN-CoV2 antibody (DID, Aug. 20). — Jordan Williams