- Collaboration to expand lenzilumab manufacturing capacity in advance of potential Emergency Use Authorization in 2020
- Commercial manufacturing to begin in 2021 at Lonza's manufacturing facility at Hayward
- The collaboration is projected to take lenzilumab through product launch and commercial supply
Quote from Jean-Christophe Hyvert, Chief Commercial Officer, Lonza:
"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."
Quote from Cameron Durrant, MD, MBA, Chief Executive Officer, Humanigen:
"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."
Burlingame (CA), USA and Basel, Switzerland, 15 September 2020 – Humanigen, a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm,' and Lonza today 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.