Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors

DONGGUAN, China, Feb. 28, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class 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.

PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability.

This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization.

"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."

About Fapon Biopharma

Fapon Biopharma specializes in discovering and developing biologics for treating cancers, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, and a platform for developing multispecific antibodies using Fibody and nanobodies. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone.

For more information about FP008 and partnership opportunities, please visit our website (https://en.faponbiopharma.com/) or contact our Business Development team.
Max Wang: max.wang@fapon.com;
Liyan Gao:  liyan.gao@fapon.com

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