Humanigen Announces Thermo Fisher Partnership to Expand Manufacturing for COVID-19 Therapeutic Candidate Lenzilumab
Humanigen, Inc., (Nasdaq: HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate lenzilumab, today announced a strategic collaboration with Thermo Fisher Scientific, a world leader in serving science, to expand the manufacturing capacity for lenzilumab, currently in a Phase 3 registration study in patients with COVID-19, to support a potential Emergency Use Authorization (EUA).
This multi-year manufacturing partnership adds to Humanigen’s large scale commercial production efforts, including recently announced partnerships with Lonza and Catalent, in advance of a potential 2020 EUA and subsequent commercialization of lenzilumab, the company’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody. Thermo Fisher will begin the technical transfer of the lenzilumab bulk drug substance process and commercial scale production could begin before the end of this year.
“Manufacturing preparation, precision and expertise are critical as we execute on