Faron Pharmaceuticals selected AGC Biologics, a CDMO, to commercially manufacture Clevegen, a humanized anti-Clever-1 antibody which targets CLEVER-1 positive tumor-associated macrophages (TAMs) and converts these immunosuppressive M2 macrophages to immune stimulating M1 macrophages. This macrophage-directed immuno-oncology switch may be used alone or in combination with other cancer treatments, according to a Faron official, who notes that 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 reportedly 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,” says Markku Jalkanen, PhD, Faron’s CEO. “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.”
“Our priority has always been to serve our customers with a strong commitment to continued innovation,” adds Patricio Massera, CEO of AGC Biologics. “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.”