FORE Biotherapeutics Secures $38M in Series D-2 for Plixorafenib Development

FORE Biotherapeutics, a biotherapeutics company in the registration phase focused on creating targeted cancer treatments, has successfully secured $38 million in Series D-2 funding. This financing round saw participation from prominent healthcare-focused investors including SR One, Medicxi, OrbiMed, and Wellington Management, among others. This latest investment brings the total funding for the Series D round, including earlier Series D and D-1 financings, to a cumulative $113 million.

Simeon George, M.D., CEO of SR One, expressed his company’s commitment to investing in innovative enterprises aiming to develop transformative therapies for areas with significant unmet medical needs. He praised Fore Biotherapeutics for its efforts in addressing BRAF driven tumors with plixorafenib, a potential first-in-class paradox breaker. Early clinical data show promise for plixorafenib as a monotherapy, suggesting it could effectively fill treatment gaps left by existing BRAF inhibitors. SR One is encouraged by the progress made and is eager to continue supporting Fore in advancing plixorafenib.

William Hinshaw, CEO of Fore, highlighted the significance of the financing in supporting the development of plixorafenib, a distinct BRAF inhibitor designed for both V600 and non-V600 mutations. The drug has shown promising data, indicating it could overcome the limitations of current BRAF inhibitors and tap into a multi-billion-dollar market opportunity. Hinshaw expressed gratitude for the investor syndicate's ongoing support and confidence in both the team and plixorafenib's potential. With this backing, Fore is well-positioned to advance its FORTE Master Protocol, aiming for multiple interim analyses and potential accelerated FDA approvals by the end of next year.

The funds will be utilized to progress the FORTE Master Protocol, a global Phase 2 clinical trial evaluating plixorafenib across different patient groups. The trial includes four sub-protocol baskets focusing on BRAF V600 Recurrent Primary CNS Tumors, Rare BRAF V600 Mutated Solid Tumors, and Solid Tumors with BRAF Fusions. The company expects interim analyses across these indications to occur in 2025.

For BRAF V600 Primary Recurrent CNS Tumors, up to 50 patients will be treated, with primary endpoints being overall response rate and median duration of response. An interim analysis for the first 25 patients is expected in Q3 2025, with potential topline data in the latter half of 2026. A Phase 1/2 study previously conducted showed a favorable 67% response rate and a median response duration of 13.9 months.

The cohort for Rare BRAF V600 Mutated Solid Tumors will involve approximately 75 patients, targeting similar endpoints as the CNS tumors trial. Interim analysis for the first 25 patients is anticipated by Q4 2025. Earlier studies revealed a 42% response rate and a median response duration of 17.8 months.

For Advanced Solid Tumors with BRAF Fusions, up to 75 patients will be engaged, focusing on the same endpoints. Interim analysis is expected by Q4 2025. Prior study results included complete responses and stable disease outcomes, highlighting plixorafenib's potential efficacy and tolerability.

Fore Biotherapeutics continues to present significant findings at major medical meetings. In April 2025, at the AACR Annual Meeting, the company shared new ctDNA results and details of its FORTE clinical trial. The results underscored a strong correlation between ctDNA changes and tumor size, suggesting ctDNA as a viable disease monitoring marker. No new mutations in MAPK pathway genes were observed, reinforcing the novel mechanism of plixorafenib.

At the upcoming ASCO Annual Meeting in 2025, Fore plans to present details of its ongoing global Phase 2 FORTE trial. As a company dedicated to innovating treatments for challenging cancer types, Fore Biotherapeutics continues to develop plixorafenib, aiming to improve patient outcomes where current therapies fall short. Plixorafenib has shown efficacy across diverse tumor types, supported by manageable safety profiles in clinical trials, with further data anticipated from ongoing studies.