Ajinomoto Bio-Pharma Services announced that it has entered into a manufacturing agreement with Humanigen, Inc., for the fill finish supply of lenzilumab, currently being studied in a Phase III clinical trial in adult, hospitalized patients with COVID-19.
“We are extremely pleased to partner with Humanigen in the fight against COVID-19 and to use our unique position as a US-based manufacturer to help simplify and secure a key part of their supply chain,” said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services. “Through this collaboration we uphold our mission to improve the health of humankind, and our employees take great pride in knowing that our efforts may ultimately help patients survive this devastating disease.”
Under the terms of the agreement, Aji Bio-Pharma will provide drug product aseptic fill finish services for Humanigen at its San Diego facility. Lenzilumab, Humanigen’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being administered as part of a U.S. multi-center, randomized, placebo-controlled, double-blinded Phase III study for COVID-19 patients. Lenzilumab neutralizes GM-CSF, a key cytokine in the initiation of a cytokine storm.
“We are excited to be working with Aji Bio-Pharma for the fill finish production of lenzilumab,” said Dr. Cameron Durrant, Chairman and CEO of Humanigen. “This partnership allows us to utilize Aji Bio-Pharma’s drug product expertise and infrastructure to provide a timely supply of lenzilumab.”