Fapon Biopharma, a Chinese developer of therapeutic antibodies and fusion proteins, announced on Thursday that it will present its latest breakthrough immunocytokine, FP008, on 14 January 2025 at the Biotech Showcase investor conference, following J.P. Morgan Healthcare Week.

This bifunctional anti-PD-1/IL-10M fusion protein is designed to address populations refractory to anti-PD-1 therapies.

FP008 is a proprietary and patented drug candidate using Fapon Biopharma's antibody technology. A first-in-class biologic, it combines an engineered IL-10 monomer (IL-10M) with an anti-PD-1 antibody, reducing the challenging toxicity associated with wild-type IL-10, while activating IL-10M at the target site. According to Fapon Biopharma, this represents a critical advancement in the field of immuno-oncology. FP008 not only inhibits exhausted CD8 T cells apoptosis and enhances their functional activity in vitro, but also significantly increases the proportion of CD8+ T cells in tumour microenvironment, exhibiting a potent anti-tumour effect in vivo.

"FP008 represents a significant leap forward in our quest to develop more effective and safer immunotherapies for cancer patients," said Max Wang, business development director at Fapon Biopharma. "By addressing the critical unmet need of PD-1 therapy-resistant tumours, FP008 has the potential to transform treatment paradigms and improve outcomes for patients who have limited options."

Fapon Biopharma plans to submit an Investigational New Drug (IND) application for FP008 to the US Food and Drug Administration (FDA) in early 2025.