Fapon Biopharma Gains FDA Approval for IND of FP008 Immunotherapy

DONGGUAN, China, Feb. 28, 2025 /PRNewswire/ -- Fapon Biopharma, a notable player in the biotech industry, has announced that the U.S. FDA has given its approval for the Investigational New Drug (IND) application for FP008. This innovative immunocytokine is designed to meet the therapeutic needs of patients with solid tumors that remain unresponsive to anti-PD-1 therapy.

FP008 represents a pioneering class of treatments that combines an anti-PD-1×IL-10M fusion protein, offering a unique mechanism of action and significant therapeutic potential for patients who are either new to anti-PD-1 treatments or have developed resistance. The engineering of the IL-10 monomer (IL-10M) significantly reduces the risk of hematologic toxicity, while the anti-PD-1 antibody aspect of the fusion protein boosts the activity of IL-10M through targeted enrichment and cis-activation.

The role of PD1 targeted antibodies is to prompt effector CD8(+) T cells towards a state of terminal exhaustion. However, recent preclinical experiments by Fapon Biopharma demonstrated that FP008 can effectively counteract this process through its IL-10M component. It significantly minimized the exhaustion of CD8(+) T cells typically induced by anti-PD-1 antibodies. In trials conducted on mice, FP008 showed a strong anti-tumor response, enhanced the presence of CD8(+) T cells within tumors, reduced their progression towards terminal exhaustion, and improved the capacity of these cells to produce and secrete key proteins such as IFN-γ and GZMB. Moreover, FP008 exhibited a promising safety profile and suitable pharmacokinetics in studies involving cynomolgus monkeys, alongside demonstrating strong potential for further development.

This advancement represents a potential paradigm shift in treatments for solid tumors, particularly for patients with few existing options. Fapon Biopharma is eager to establish strategic alliances with biopharmaceutical companies around the globe to jointly advance FP008 through clinical stages and potentially bring the treatment to market.

President Vincent Huo commented on the importance of global partnerships for the company, emphasizing the value of collaborating to drive forward innovations in tumor immunotherapy. He invited potential partners to capitalize on Fapon Biopharma's comprehensive preclinical data and clinical-stage assets to push the boundaries of cancer treatment options.

Fapon Biopharma is a leader in the discovery and development of biologics aimed at treating a range of conditions, including cancer and autoimmune diseases. The company employs state-of-the-art technologies to create advanced drug discovery platforms. These include a globally recognized mammalian cell display technology platform for antibody discovery, a platform dedicated to IL-10M fusion proteins, and another for developing multispecific antibodies, utilizing Fibody and nanobody technologies.

Fapon Biopharma prides itself on a distinct pipeline of drug candidates and has developed extensive capabilities covering all stages of the drug development process. From the initial discovery and preclinical research to Chemistry, Manufacturing and Controls (CMC), and into early clinical development, the company remains committed to delivering innovative, safe, and affordable biologics. Through their efforts, Fapon aims to make these advanced treatments more accessible to patients worldwide, fulfilling unmet medical needs with cutting-edge solutions.