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FDA Approves Fapon Biopharma’s FP008 Cancer Therapy IND Application

FP008 is a novel fusion protein combining anti-PD-1 and IL-10M, designed to treat anti-PD-1 naïve or resistant patients with reduced toxicity.

The U.S. Food and Drug Administration (FDA) has approved Fapon Biopharma’s Investigational New Drug (IND) application for FP008, an immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy. FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the a...

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