Ajinomoto Bio-Pharma Services and Humanigen Expand Manufacturing Agreement to Support Fill Finish for Investigational COVID-19 Therapeutic, Lenzilumab, Nearing Completion of Phase 3 Study

Ajinomoto Bio-Pharma Services  and Humanigen announced the companies will be expanding their manufacturing agreement for the fill finish supply of lenzilumab, which is one of the few Phase 3 treatment options in development for patients hospitalized with COVID-19.

Aji Bio-Pharma will assume a key role in simplifying the supply chain efforts for Humanigen by providing drug product aseptic fill finish services at its San Diego facility to support continued clinical trial efforts through potential commercialization. Humanigen is actively enrolling patients in a Phase 3 study in the U.S. and Brazil and preparing for a potential COVID-19 Emergency Use Authorization (EUA) for lenzilumab.

“We are very pleased to be working with Aji Bio-Pharma for the fill finish production of lenzilumab,” said Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “This partnership allows us to utilize Aji Bio-Pharma’s high quality drug product aseptic fill finish services to provide a timely supply of lenzilumab as we near the end of our clinical phase 3 study and prepare for EUA application submission.”

“We are excited to continue to support Humanigen’s efforts to provide this potential therapeutic in the fight against COVID-19,” said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services. “Through this collaboration, we are able to leverage our drug product experience, infrastructure and strong regulatory track record to assist in the efforts that may ultimately help patients struggling with this devastating disease.”