Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce it has entered into a manufacturing services agreement with CytoDyn Inc., a late stage biotechnology company, for the supply of the investigational new drug, leronlimab (PRO 140), which is currently being used in clinical trial protocols for Mild-to-Moderately Ill and Severely Ill COVID-19 patients.
Aji Bio-Pharma provides high quality drug product aseptic fill finish services for CytoDyn. Leronlimab, a novel CCR5 antagonist with the potential for multiple therapeutic indications, has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by the U.S. Federal Drug Administration (FDA) as part of Phase 1, Phase 2 and Phase 2b/3 clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized clinical trials for Phase 2 and Phase 2b/3.
"We are very excited to support CytoDyn's efforts to utilize this promising antibody therapeutic in the fight against COVID-19," said Kristin DeFife, Ph.D., Sr. VP of Operations & Site Head at Ajinomoto Bio-Pharma Services. "This partnership reinforces our company's mission to improve the health of humankind and underscores our vision statement being a leading, trusted, innovative partner to our clients and our people."
"We are extremely pleased to already have been collaborating with Aji Bio-Pharma for the production of leronlimab for other therapeutic indications, allowing us to quickly provide this therapeutic to COVID-19 patients in clinical trials," said Nader Pourhassan, Ph.D., President and CEO of CytoDyn. "Aji Bio-Pharma's drug product experience, infrastructure and strong regulatory track record were important to this partnership and in the timely supply of this therapeutic."