Highlights of FORE Biotherapeutics’ Pipeline Achievements and 2025 Strategic Objectives
Highlights of FORE Biotherapeutics’ Pipeline Achievements and 2025 Strategic Objectives
FORE Biotherapeutics, a registration-stage biotherapeutics company focused on developing targeted therapies for cancer, has highlighted recent achievements in its pipeline and outlined its strategic objectives for 2025. The company is poised for significant milestones in the coming year as it advances its lead drug candidate, plixorafenib, a novel BRAF inhibitor. FORE Biotherapeutics aims to address significant gaps in treatment for cancers with BRAF mutations and fusions, with an emphasis on advancing the development of plixorafenib for multiple indications.
CEO William Hinshaw Highlights 2025 Outlook
William Hinshaw, Chief Executive Officer of FORE Biotherapeutics, will present a detailed update on the company’s progress and strategic direction at the 43rd Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2025, at 5:30 p.m. PT in San Francisco. Hinshaw will discuss the exciting opportunities ahead for the company, particularly focusing on the development of plixorafenib, which represents a multi-billion dollar opportunity in oncology. The company is looking to accelerate its trials and further develop plixorafenib as both a monotherapy and a potential combination therapy.
“2025 will be an exciting year at FORE, with multiple value-creating catalysts anticipated in the near term across our trials. Our focus will be continued execution of plixorafenib’s differentiated monotherapy development, which we believe holds great promise for patients with BRAF-driven tumors,” said Hinshaw. “Plixorafenib’s unique mechanism of action targets not only the constitutively active BRAFV600 monomers but also disrupts other mutant forms, such as BRAF class II dimers, fusions, and splice variants, which distinguishes it from current therapies. We are encouraged by the safety and efficacy data from our ongoing registrational trials.”
Highlights of 2024 Achievements and Leadership Expansion
In 2024, FORE Biotherapeutics achieved significant progress, both in clinical trials and through strategic additions to its leadership team. The company appointed William Hinshaw as CEO, Michael Byrnes as CFO, and Payman Darouian as Senior Vice President of Corporate Development, Strategy, and Commercial. The new leadership team brings extensive experience from top pharmaceutical companies and high-growth biotechnology firms, strengthening the company’s capabilities and positioning it for success.
One of the key highlights of 2024 was the continued execution of the FORTE Master Protocol, a global clinical trial designed to evaluate plixorafenib in distinct patient populations. The protocol includes several indications, such as BRAF V600 recurrent primary central nervous system (CNS) tumors, rare BRAF V600-mutated solid tumors, and solid tumors with BRAF fusions.
Progress Highlights in Plixorafenib Trials
FORE Biotherapeutics has made significant strides in its clinical trials for plixorafenib, which is currently being evaluated in several pivotal studies. The company advanced the enrollment of patients in its registration-intended basket trials for three key indications:
- BRAF V600 Recurrent Primary CNS Tumors: Enrollment continued in this trial, which is focused on up to 50 patients with recurrent primary CNS tumors harboring the BRAF V600 mutation. Preliminary results from a prior trial showed a 67% partial response rate in MAPK pathway inhibitor-naïve adults, with a median duration of response (DOR) of 13.9 months.
- Rare BRAF V600 Mutated Solid Tumors: FORE Biotherapeutics initiated enrollment in a registration-intended trial for patients with rare BRAF V600-mutated solid tumors. The earlier trials demonstrated a promising partial response rate of 42%, with a median DOR of 17.8 months in MAPKi-naïve adults.
- Solid Tumors with BRAF Fusions: The company also continued enrollment in a trial targeting patients with BRAF fusion-positive advanced solid tumors. Previous results demonstrated encouraging single-agent activity, including a complete response with a DOR of 66.7+ months.
Additionally, FORE presented nonclinical data at the AACR 2024, highlights that plixorafenib, when combined with binimetinib (a MEK inhibitor), exhibited superior potency compared to other BRAF inhibitors. The company also presented safety and efficacy data at the International Symposium on Pediatric Neuro-Oncology and the Ovarian Cancer Research Symposium, highlighting the potential of plixorafenib in both pediatric and adult populations.
Strategic Objectives for 2025 and Key Highlights
Looking ahead to 2025, FORE Biotherapeutics has set several key objectives:
- Continued Execution of the FORTE Master Protocol: The company plans to conduct interim analyses for its three monotherapy indications in the second half of 2025. These analyses will assess the first 25 evaluable patients in each cohort, and positive results could pave the way for topline data and potential New Drug Application (NDA) submission to the FDA under the Accelerated Approval pathway by 2026.
- BRAF V600 Recurrent Primary CNS Tumors: An interim efficacy analysis is expected in Q3 2025, with topline data anticipated in 2026.
- Rare BRAF V600 Mutated Solid Tumors: An interim efficacy analysis is planned for the fourth quarter of 2025.
- BRAF Fusion Solid Tumors: Similarly, an interim analysis is expected for the fourth quarter of 2025.
Final Highlights on FORE Biotherapeutics’ Impact and Future
FORE Biotherapeutics is a registration-stage oncology company dedicated to developing innovative therapies for cancers that are difficult to treat. The company’s lead asset, plixorafenib (FORE8394), is a first-in-class BRAF inhibitor designed to address treatment gaps left by earlier-generation BRAF inhibitors. Plixorafenib has demonstrated promising single-agent efficacy across various tumor types in Phase 1/2a trials and is currently enrolling patients in the FORTE global registrational basket trial to support its development in multiple indications. With a focus on targeted therapies, FORE aims to deliver better outcomes for patients with some of the most challenging cancers.
As the company continues to progress through clinical trials, its ability to execute on key milestones in 2025 will be pivotal in establishing plixorafenib as a transformative therapy in oncology. The coming year is filled with exciting highlights that will shape the future of cancer treatment.
