Wednesday, September 16, 2020
Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,’ and Lonza announced a strategic collaboration to expand the manufacturing capacity for lenzilumab, currently in Phase 3 clinical trials for COVID-19, in advance of potential Emergency Use Authorization in 2020 and subsequent commercialization.
The collaboration enables Humanigen to leverage Lonza's monoclonal antibody manufacturing and regulatory expertise. Lenzilumab represents Humanigen's proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody with the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
This collaboration provides Humanigen with additional capacity for cGMP production of lenzilumab with operations intended to start in 2021. Production of lenzilumab will begin at Lonza's 2,000L manufacturing facilities at Hayward (CA), USA. Technology transfer is expected to begin in Q3 2020.
More details on Humanigen's programs in COVID-19 can be found at www.humanigen.com/covid-19, and details of the US Phase 3 potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.