Pharma Focus Asia

AGC Biologics Partners with Faron Pharmaceuticals to Manufacture Cancer Treatments

Wednesday, May 06, 2020

AGC Biologic s , a global contract biopharmaceutical manufacturing and development organization (CDMO), has been selected to commercially manufacture the Clevegen treatment for partner  Faron  Pharmaceuticals Oy (AIM: FARN, First North: FARON), a biopharmaceutical company in clinical phase. Clevegen is a humanized anti-Clever-1 antibody that targets CLEVER-1 positive tumor associated macrophages (TAMs) and converts these largely immunosuppressive M2 macrophages into M1 immune-stimulating macrophages. This unique macrophage-directed immuno-oncology switch could 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 with the goal of industrial scale manufacturing for Clevegen," said Dr. Markku Jalkanen , CEO of Faron. "This enables flexible and cost-effective manufacturing to meet the growing need in clinical development, while ensuring rapid and regulatory expansion of production for business needs. At Faron, we believe it is important to progress throughout clinical development and inform regulators (FDA, EMA) at the end of the phase II meeting for Clevegen. This could take place, depending on the results of Part II of the MATINS study, by the second half of 2020. "

"Our priority has always been to serve our customers with a strong commitment to continuous innovation," said Patricio Massera , CEO of AGC Biologics. "We are proud to partner with Faron on such an important treatment and to share our decades of experience in commercial scale production of biotech products."

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