AGC Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), has been selected to commercially manufacture the treatment Clevegen for partner Faron Pharmaceuticals, a clinical stage biopharmaceutical company. Clevegen is a humanized anti-Clever-1 antibody which targets CLEVER-1 positive tumor associated macrophages (TAMs) and converts these highly immunosuppressive M2 macrophages to immune stimulating M1 macrophages. This unique macrophage-directed immuno-oncology switch may be used alone or in combination with other cancer treatments.
 
Data from Faron’s ongoing MATINS trial has shown that Clevegen is safe and well-tolerated, making it a low-risk candidate for combination with existing cancer therapies. Clevegen has also shown early clinical benefits in patients who have exhausted all other treatment options.
 
“We are pleased to initiate this collaboration with AGC Biologics aiming at industrial scale manufacturing of Clevegen,” said Markku Jalkanen, chief executive officer, Faron. “This allows flexible and cost-efficient manufacturing to fulfill the growing need in clinical development while ensuring rapid and regulatory-ready scale up of the production for commercial needs. At Faron, we feel it’s important to progress along the clinical development and report to the regulators (FDA, EMA) at the end of the phase II meeting for Clevegen. This could take place, depending on the MATINS study Part II results, as soon as H2-2020.”
 
Patricio Massera, chief executive officer, AGC Biologics, said, “Our priority has always been to serve our customers with a strong commitment to continued innovation. We’re proud to be partnering with Faron on such an important treatment and sharing our decades of experience in commercial scale production of biotechnological products.”