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Aji Bio-Pharma provides drug product aseptic fill finish services for CytoDyn's Leronlimab, currently being used in clinical trials for COVID-19 patients
May 5, 2020
By: Contract Pharma
Contract Pharma Staff
Ajinomoto Bio-Pharma Services (Aji Bio-Pharma) has entered 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 drug product aseptic fill finish services for CytoDyn. Leronlimab, a 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. FDA as part of Phase I, Phase II and Phase IIb/III trials. CytoDyn is currently enrolling patients in two clinical trials for Phase II and Phase IIb/III. “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.”
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