Humanigen Inc (OTCQB:HGEN), which is focused on its lead drug lenzilumab being used to prevent and treat an immune hyper-response called the cytokine storm in Coronavirus (COVID-19) patients, revealed on Tuesday a strategic collaboration with Swiss firm Lonza to expand the manufacturing capacity for lenzilumab.
This week, Humanigen’s Phase 3 registration trial of lenzilumab in patients with COVID-19 was unanimously recommended for continuation without modification by an independent data safety monitoring board (DSMB) after a planned interim analysis. Lenzilumab is currently in Phase 3 clinical trials for COVID-19, ahead of potential Emergency Use Authorization in 2020 and subsequent commercialization.
Burlingame, California-based Humanigen said the collaboration enables it to “leverage” Lonza's monoclonal antibody manufacturing and regulatory expertise.
Lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being evaluated for its potential to prevent and treat the so-called cytokine storm, which triggers the sometimes fatal respiratory distress syndrome seen in severe cases of COVID-19. Lenzilumab was also selected by the National Institutes of Health for its COVID-19 Big Effect Trial.
"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," said Humanigen CEO Cameron Durrant.
The 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 2,000 liter manufacturing facilities at Hayward in California. “Technology transfer is expected to begin in Q3 2020,” said the company.
The collaboration is projected to take lenzilumab through product launch and commercial supply.
"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,” said Lonza chief commercial officer Jean-Christophe Hyver.
“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."
Contact the author Uttara Choudhury at [email protected]
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