Ajinomoto Bio-Pharma Services, Humanigen in Manufacturing Agreement for COVID-19 Biologic

June 1, 2020

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

On May 27, 2020, Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), a contract development and manufacturing organization, announced that it has entered into a manufacturing agreement with Humanigen, a clinical-stage biopharmaceutical company specializing in cell and gene therapies, for the fill finish supply of lenzilumab, a biologic currently being studied in a Phase III clinical trial for treating hospitalized patients with COVID-19.

Under the agreement, Aji Bio-Pharma will provide drug product aseptic fill finish services for Humanigen at its San Diego, CA, facility. Lenzilumab, Humanigen's proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, is being administered as part of a US 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 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, PhD, senior vice-president of operations and site head at Ajinomoto Bio-Pharma Services, in a company press release. "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."

"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, in the press release. "This partnership allows us to utilize Aji Bio-Pharma's drug product expertise and infrastructure to provide a timely supply of lenzilumab."

Source: Ajinomoto Bio-Pharma Services