Fapon Biopharma Announces the enrollment of the First Patient in the Phase I Clinical Trial of FP008, A First-in-Class Immunotherapy for Solid Tumors

DONGGUAN, China, Aug 5, 2025 /PRNewswire/ -- Fapon Biopharma, a biotech in developing therapeutic antibodies and fusion proteins, is delighted to announce the completion of the first patient enrollment  in China for its Phase I clinical trial of FP008 , a first-in-class immunotherapy for solid tumors, at Zhejiang Cancer Hospital. The patient has completed the Dose Limiting Toxicity (DLT) observation period with a favorable safety profile. The trial aims to evaluate the safety and tolerability of FP008 in patients with advanced solid tumors. 

As the latest next generation of immuno-oncology (IO) approach, FP008 is a novel anti-PD-1 × IL-10M fusion protein designed to overcome the limitations of current PD-1 inhibitors by using a proprietary IL-10 mutant that eliminates the toxicity associated with the wild-type protein. It represents a potential new therapeutic option for patients who are refractory to or relapsed from anti-PD-1/PD-L1 therapies. Preclinical studies demonstrated that FP008 significantly reduces PD-1 antibody-mediated CD8⁺ T-cell exhaustion and exhibits potent anti-tumor efficacy. Key findings include: 

- Enhanced infiltration of CD8⁺ T-cells into tumors;
- Reduced terminal exhaustion differentiation of CD8⁺ T-cells;
- Increased secretion of IFN-γ and GZMB in terminally exhausted CD8⁺ T-cells.

Additionally, FP008 showed favorable safety and pharmacokinetic (PK) profiles in cynomolgus monkey studies, supporting its clinical potential. FP008 has received Investigational New Drug (IND) approval from both the U.S. FDA and China's NMPA.

The multi-center Phase I trial in China is led by Zhejiang Cancer Hospital, with two additional sites participating. Professor Zhengbo Song, Principal Investigator at Zhejiang Cancer Hospital, stated: "FP008 offers a promising therapeutic strategy for solid tumor patients resistant to anti-PD-1 antibodies. Its unique mechanism could address a critical unmet clinical need in immuno-oncology. We look forward to further evaluating its safety and efficacy in the clinic." 

About FP008

FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation. This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization. 

About Fapon Biopharma 

Fapon Biopharma specializes in discovering and developing biologics for cancer treatment, autoimmune diseases and other diseases where there are unmet medical needs. Leveraging cutting-edge technologies, we have built advanced drug discovery platforms, including an antibody discovery platform based on the globally leading mammalian cell display technology, a platform for generating IL-10M fusion proteins, a TCE platform based on cross-species CD3 nanobody of human and monkey. With a differentiated pipeline of leading drug candidates, we have established capabilities that cover the entire drug development process from drug discovery, preclinical research, Chemistry, Manufacturing and Controls (CMC) to early clinical development. Committed to innovation, we strive to deliver safer, more efficacious, affordable, and accessible biologics for everyone.

For more information about FP008 and partnership opportunities, please visit our website (https://en.faponbiopharma.com/) or contact our Business Development team.
Max Wang: [email protected];
Liyan Gao: [email protected]

SOURCE Fapon Biopharma