Ajinomoto Bio-Pharma Services Announces Manufacturing Partnership with CytoDyn for Drug Product Used in COVID-19 Clinical Trials
May 5, 2020 – San Diego, CA – 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.”
About Ajinomoto Bio-Pharma Services
Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client’s needs. Learn more: www.AjiBio-Pharma.com