FDA Approves Investigational New Drug Application for Fapon Biopharma’s Novel Immunotherapy for Solid Tumors

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The FDA has approved an Investigational New Drug application for Fapon Biopharma’s FP008, an immunocytokine designed for patients with solid tumors that have not responded to existing PD-1-targeting immunotherapies. The treatment combines an anti-PD-1 antibody with IL-10M, a modified protein developed to reduce immune cell exhaustion.¹

"Global collaboration is central to our vision," said Vincent Huo, president, Fapon Biopharma, in a press release. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy."

Many cancers exploit PD-1 to evade immune attacks, prompting anti-PD-1 therapies to block this pathway and reactivate immune cells. However, prolonged CD8(+) T-cell stimulation by these therapies can drive the cells into a terminally exhausted state, diminishing their ability to fight cancer over time.¹

According to Fapon, FP008 demonstrated strong anti-tumor effects in preclinical models. In mouse studies, it enhanced tumor infiltration, prevented CD8(+) T-cell exhaustion, and increased the production of key immune-activating proteins, including interferon-gamma and granzyme B. In monkey studies, the treatment showed a promising safety and pharmacokinetic profile.^1,2

Last month, Fapon introduced FP008 at the Biotech Showcase investor conference following the JP Morgan Healthcare Week.²

"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, Fapon Biopharma, in a press release. "By addressing the critical unmet need of PD-1 therapy-resistant tumors, FP008 has the potential to transform treatment paradigms and improve outcomes for patients who have limited options."

References

1. Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors. PR Newswire. February 28, 2025. Accessed February 28, 2025. https://prnmedia.prnewswire.com/news-releases/fapon-biopharma-announces-fda-approval-of-ind-for-fp008-a-first-in-class-immunotherapy-for-solid-tumors-302388341.html

2. Fapon Biopharma Introduces FP008 at Biotech Showcase: A Safer and More Effective Immunotherapy for Refractory Cancers. PR Newswire. January 2, 2025. Accessed February 28, 2025. https://prnmedia.prnewswire.com/news-releases/fapon-biopharma-introduces-fp008-at-biotech-showcase-a-safer-and-more-effective-immunotherapy-for-refractory-cancers-302341164.html