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The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.
Lonza and Humanigen, a clinical-stage biopharmaceutical company focused on the treatment of immune hyper-response (cytokine storm), announced on Sept. 15, 2020 that they have entered into a strategic collaboration to expand the manufacturing capacity for lenzilumab, a therapeutic candidate for COVID-19 currently in Phase III clinical trials. The partnership for manufacturing expansion is established in advance of a potential Emergency Use Authorization expected in 2020 and subsequent commercialization.
Lenzilumab comes from Humanigen's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody (mAb) platform. This mAb has the potential to prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.
The collaboration between Lonza and Humanigen enables Humanigen to leverage Lonza's mAb manufacturing and regulatory expertise and provides Humanigen with additional capacity for current good manufacturing practices (CGMP) production of lenzilumab. Operations are intended to start in 2021 and production of lenzilumab will begin at Lonza's 2000-L manufacturing facilities in Hayward, CA. Technology transfer is expected to begin in the third quarter of 2020.
"In an effort to change the course of this pandemic, advancing lead COVID-19 therapeutics requires matched supply chain efforts and expertise to meet the continued and urgent patient needs. COVID-19 has highlighted the need for heightened industry collaboration and coordination and we are excited to work closely with Humanigen as we work to combat this global health crisis," said Jean-Christophe Hyvert, chief commercial officer, Lonza, in a company press release.
"We are ramping up our manufacturing efforts for lenzilumab, our lead drug candidate, and this collaboration with Lonza, a global manufacturing leader with expertise in technology transfer and an established track record of working with regulatory bodies for approved and commercialized products, comes at a crucial time to meet production demand for COVID-19 therapeutics this winter," stated Cameron Durrant, MD, CEO, Humanigen, in the press release.