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 anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation.

Fapon Biopharma’s FP008 effectively counteracts PD-1 antibody-mediated exhaustion of CD8(+) T cells, enhancing anti-tumor effects and offering a new treatment option for solid tumors.

“Global collaboration is central to our vision,” stated President Vincent Huo. “We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy.”