#China #Immunotherapy #Dongguan #Fapon Biopharma #FP008

Fapon Biopharma Receives FDA Approval for FP008

Fapon Biopharma, an innovative biotechnology firm specializing in the development of therapeutic antibodies and fusion proteins, has proudly announced that the U.S. Food and Drug Administration (FDA) has granted approval for an Investigational New Drug (IND) application for FP008. This drug is notable for being the first immunocytokine of its class designed specifically to meet the needs of patients with solid tumors who do not respond to existing PD-1 therapies.

About FP008

FP008 represents a novel approach to treating patients with solid tumors through its unique design. It is an anti-PD-1×IL-10M fusion protein that employs an innovative mechanism of action aimed at those who are naive or resistant to anti-PD-1 treatments. One of the crucial advancements in the development of this drug is the engineering of IL-10 Monomer (IL-10M), which significantly reduces hematological toxicity, thereby enhancing patient safety.

The anti-PD-1 antibody component works synergistically to amplify the effects of IL-10M by promoting targeted enrichment at PD-1 sites and facilitating cis-activation. Such a mechanism effectively counters the differentiation of effector CD8(+) T-cells into an exhausted state, a common outcome with conventional PD-1 targeted therapies.

In preliminary experiments, FP008 demonstrated a remarkable ability to reverse the exhaustion of CD8(+) T-cells induced by anti-PD-1 antibodies, resulting in significantly improved cellular responses. The preclinical studies indicated a robust anti-tumor efficacy, with FP008 notably enhancing the infiltration of intratumoral CD8(+) T-cells and reducing their terminal differentiation into exhausted states. Furthermore, the ability of these terminally exhausted CD8(+) T-cells to produce and secrete key cytokines such as IFN-γ and GZMB was also improved.

These findings are particularly promising for patients who have limited options left, adding hope to those battling advanced solid tumors. The safety and pharmacokinetics of FP008 have also shown favorable outcomes in studies involving Cynomolgus monkeys, supporting its further development as a viable treatment option.

Future Collaborations

This breakthrough presents significant implications for shifting the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies globally to advance FP008 through clinical trials and towards commercial availability. The company believes that global collaboration is essential to its mission and encourages prospective partners to leverage its preclinical findings and clinical assets to develop innovative tumor immunotherapies together.

President Vincent Huo stated, “Global collaboration is at the heart of our vision. We invite partners to utilize our solid preclinical data and clinical stage assets to collectively push the boundaries of innovation in tumor immunotherapy.”

About Fapon Biopharma

Fapon Biopharma stands at the forefront of discovering and developing biologics aimed at treating cancer, autoimmune disorders, and other conditions marked by unmet medical needs. Utilizing state-of-the-art technologies, the company has established leading platforms for drug discovery, including an antibody discovery platform based on world-leading mammalian cell-display technology, an IL-10M fusion protein production platform, and a multispecific antibody development platform using Fibody and nanobodies. Their diverse pipeline of leading candidates reflects their established capabilities across the entire drug development process, from initial discovery and preclinical research to CMC (Chemistry, Manufacturing, and Control) and early clinical development. Fapon Biopharma is committed to innovation, striving to develop biologics that are safer, more effective, affordable, and accessible to all.

For additional information about FP008 and possible partnership opportunities, visit Fapon Biopharma or contact their Business Development Team. Max Wang can be reached at max.wang@example.com and Liyan Gao at liyan.gao@example.com.