Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug

May 5, 2020
Pharmaceutical Technology Editors

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

On May 5, 2020, Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), a contract development and manufacturing organization, announced that it has entered into a manufacturing services agreement with CytoDyn, 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.

Leronlimab is a novel CCR5 antagonist with the potential for multiple therapeutic indications. It 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 FDA as part of Phase I, Phase II, and Phase IIb/III clinical trials. CytoDyn is currently enrolling patients in two placebo-controlled randomized 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, PhD, senior vice-president of Operations and site head at Ajinomoto Bio-Pharma Services, in a company press release.

"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, PhD, president and CEO of CytoDyn, in the press release. "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."

Source: Ajinomoto Bio-Pharma Services