FP008 / FAPON - LARVOL DELTA

Fapon Biopharma and MOTE Therapeutics to Present Dual-Platform B-Cell Immunotherapy Franchise at BIO 2026 (PRNewswire) - "This franchise features two differentiated programs targeting CD19 and BCMA, designed to deliver potent and sustained B-cell depletion: FPE024, a potential best-in-class CD19×BCMA×CD3 tri-specific T-cell engager for autoimmune indications, with IND filing targeted Q1 2027; and MTX001, a CD19×BCMA in vivo CAR-T program powered by the mobilize tLNP platform, with an investigator-initiated first-in-human study expected in Q4 2026....Leading the clinical-stage pipeline is FP008, a global first-in-class PD1×IL10M fusion protein for immuno-oncology, currently in Phase I development with key readout anticipated in 2026....Both FP012 and FPE021 are entering IND-enabling CMC/GLP toxicology in 2026."

First-in-human • IND • New trial • P1 data • Preclinical • Gastrointestinal Cancer • Immunology • Inflammatory Bowel Disease • Solid Tumor • Systemic Lupus Erythematosus

FP008, a novel anti-PD-1×IL-10M fusion protein for cancer therapy (AACR 2025) - "Furthermore, the STAT3 signaling was greatly enhanced after PD-1 crosslinking, indicating FP008 may have strong activity on TILs where PD-1 is highly expressed.In both CT26 and MC38 tumor models in hPD-1 knock-in mice, FP008 dose dependently inhibited tumor growth, with stronger anti-tumor efficacy and longer survival than Keytruda. In a GLP toxicology study in cynomolgus monkeys, FP008 was well tolerated at the dose of 10 mg/kg, and produced minimal decrease of erythrocyte and no tissue damage.In conclusion, FP008 showed novel characteristics such as the synergistic function of anti-PD-1 and IL-10M, cis-activation of IL-10M by PD-1 enrichment and improved safety profiles. It demonstrated promising potential for clinical therapy for the anti-PD-1 naïve or resistant patients."

Oncology • CD8 • IFNG • IL10

Fapon Biopharma Publishes Pioneering Research in Cell Reports Medicine on FP008, an anti-PD 1 X IL-10M Fusion Protein for Cancer Immunotherapy (PRNewswire-Asia) - "The study demonstrated FP008's robust anti-tumor activity across multiple mouse tumor models, including those resistant to anti-PD-1 therapy. FP008 reversed terminal exhaustion of CD8⁺ T cells and restored their functional capacity through localized activation, minimizing systemic exposure....Phase I clinical trial is currently ongoing with readout expected later this year."

P1 data • Preclinical • Solid Tumor

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 (PRNewswire) - "Fapon Biopharma...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....The multi-center Phase I trial in China is led by Zhejiang Cancer Hospital, with two additional sites participating."

Trial status • Solid Tumor

A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Zhuhai Fapon Biopharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

Fapon Biopharma to Showcase Differentiated Pipeline, Including Phase 1 Immunocytokine FP008, and Innovative Technology Platforms at BIO 2025 (PRNewswire) - "Fapon Biopharma...is pleased to announce its participation in the BIO International Convention 2025 (BIO 2025), taking place June 16-19 in Boston Convention & Exhibition Center. The company will exhibit at Booth #1851, presenting its differentiated pipeline, including the flagship Phase 1 immunocytokine FP008, a portfolio of promising early-stage candidates for oncology and autoimmune diseases, and its suite of proprietary technology platforms, while actively seeking global partnerships...The company will also feature promising preclinical candidates targeting oncology (FP010, FP011, FPE021) and autoimmune diseases (FPE022, FPE024), highlighting its expanding research capabilities."

P1 data • Preclinical • Immunology • Solid Tumor

A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=108 | Not yet recruiting | Sponsor: Zhuhai Fapon Biopharma Co., Ltd.

New P1 trial • Solid Tumor

Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors (PRNewswire) - "Fapon Biopharma...is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy."

IND • Solid Tumor

Fapon Biopharma Introduces FP008 at Biotech Showcase: A Safer and More Effective Immunotherapy for Refractory Cancers (PRNewswire) - "Fapon Biopharma...will present its latest breakthrough immunocytokine, FP008, on Jan 14, 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. The presentation will introduce Fapon Biopharma's continued strength and innovation in the development of anticancer drugs....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 tumor microenvironment, exhibiting a potent anti-tumor effect in vivo....Fapon Biopharma plans to submit an Investigational New Drug (IND) application for FP008 to the U.S. Food and Drug Administration (FDA) in early 2025."

IND • Preclinical • Oncology • Solid Tumor

Fapon Biopharma Announces a Safer Immunotherapy for Cancers (PRNewswire) - "At Bio International Convention 2024...Fapon Biopharma...has announced an immunocytokine with modified IL-10M fused to anti-PD-1 antibody, codenamed FP008. This fusion protein provides a promising therapeutic strategy for solid tumors refractory to anti-PD-1 therapy...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....Fapon Biopharma plans to submit an IND application for FP008 to the FDA in early 2025."

IND • New molecule • Solid Tumor