On June 3, 2024 Fapon Biopharma, an innovator in developing therapeutic antibodies and fusion proteins, reported an immunocytokine with modified IL-10M fused to anti-PD-1 antibody, codenamed FP008 at Bio International Convention 2024, which is taking place here in San Diego during June 3-6 (Press release, Fapon Biopharma, JUN 3, 2024, View Source [SID1234644049]). This fusion protein provides a promising therapeutic strategy for solid tumors refractory to anti-PD-1 therapy. The groundbreaking announcement is a testimony to Fapon Biopharma’s strength in developing anticancer drugs.
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FP008 is a patent-pending drug candidate developed by Fapon Biopharma using cutting-edge antibody technology. It stands out as a first-in-class biologic candidate combining IL-10M (an attenuated IL-10 monomer variant) and an anti-PD-1 antibody, providing a targeted therapy with enhanced efficacy while significantly reducing the challenging toxicity associated with wtIL-10. This is a critical advancement in the field. FP008 not only reduces the apoptosis of the exhausted CD8+ T cells and restores their activity in vitro, but also significantly increases the level of CD8+ T cells within the tumor microenvironment, exhibiting a potent anti-tumor effect in vivo. It exhibited good druggability and was well tolerated in a toxicity study of up to 10 mpk in cynomolgus monkeys. As a result, FP008 is a viable drug candidate.
FP008 is poised to have a substantial impact on immunotherapy for cancer in patients who do not respond to existing treatments. The company aims to present it to a global audience and seek partners to drive its development for the benefit of cancer patients around the world eventually.
Fapon Biopharma plans to submit an IND application for FP008 to the FDA in early 2025. The company remains committed to developing more effective and more accessible therapeutics with consistent innovation and collaboration.