Humanigen Inc (NASAQ:HGEN) announced Wednesday a strategic collaboration with Thermo Fisher Scientific Inc (NYSE:TMO), designed to boost the manufacturing capacity for its potential coronavirus (COVID-19) drug lenzilumab.
The company is making a big push with the hopes of getting Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) this year. The new multi-year manufacturing partnership is another jolt to the company’s production efforts, coming on the heels of recently announced partnerships with Lonza and Catalent.
Lenzilumab is currently in a Phase 3 registration study in patients with COVID-19, a key part of the EUA process.
For now, 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, the company said.
“Manufacturing preparation, precision and expertise are critical as we execute on an aggressive strategy, pending a potential EUA from the FDA, to deliver a COVID-19 therapeutic this winter that has the potential to reduce the risk of ventilation or death and send patients home from the hospital earlier,” CEO Cameron Durrant said in a statement. “Thermo Fisher provides biologics manufacturing expertise and scalable capacity to further support our production and growth trajectory."
Lenzilumab is designed to treat what is known as the cytokine storm, an overactive immune response to conditions such as COVID-19 that can cause inflammation, fatigue and, in severe cases, organ failure.
“Effective therapeutics are an important part of the overall approach to curb the arc of the current pandemic and we are committed to enabling leading therapeutic innovations forward for patients through comprehensive supply chain capabilities and expertise,” said Leon Wyszkowski, president, commercial operations for Thermo Fisher’s pharma services business.
Lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody drug candidate, is being evaluated in an ongoing Phase III trial and was selected by the National Institutes of Health for its COVID-19 Big Effect Trial.
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