Fapon Biopharma Publishes Pioneering Research in Cell Reports Medicine on FP008, an anti-PD 1 X IL-10M Fusion Protein for Cancer Immunotherapy

Core Insights - Fapon Biopharma has published pioneering research on FP008, a novel bifunctional fusion protein designed to enhance cancer immunotherapy by reactivating exhausted T cells within tumors [1][2] Group 1: Product Development - FP008 is a first-in-class fusion protein combining anti-PD-1 and engineered IL-10M, aimed at overcoming limitations in current cancer therapies [1] - The engineered IL-10M shows a significant reduction in toxicity compared to traditional IL-10, enabling targeted delivery to PD-1-positive exhausted CD8 T cells [2] - FP008 has demonstrated robust anti-tumor activity in multiple mouse tumor models, including those resistant to anti-PD-1 therapy, by reversing T cell exhaustion [3] Group 2: Safety and Efficacy - Comprehensive GLP toxicology studies in cynomolgus monkeys indicate a favorable safety profile for FP008 at doses up to 10 mg/kg, with no significant hematological adverse events [4] - The innovative "cis-delivery" mechanism of FP008 mitigates systemic toxicity while potentially enhancing anti-tumor immune responses [2] Group 3: Regulatory Progress - FP008 has cleared Investigational New Drug (IND) applications with both the U.S. FDA and China NMPA, with a Phase I clinical trial currently ongoing [5] - The readout from the Phase I clinical trial is expected later this year, marking a significant step in the development of therapies for patients with advanced solid tumors [5] Group 4: Company Overview - Fapon Biopharma specializes in developing biologics for cancer treatment and other diseases with unmet medical needs, utilizing advanced drug discovery platforms [6] - The company is committed to delivering safer, more efficacious, and accessible biologics through innovative research and development [6]