FORE Biotherapeutics, a registration stage biotherapeutics company, is dedicated to developing targeted therapies for cancer patients. The company has recently highlighted its pipeline achievements and outlined strategic objectives for 2025. William Hinshaw, CEO of Fore Biotherapeutics, will present these developments at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA, on January 14, 2025.
Fore's focus in 2025 includes the continued development of plixorafenib, a novel BRAF inhibitor with a unique mechanism of action. Plixorafenib is designed to inhibit not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupt constitutively active dimeric BRAF class II mutants, fusions, splice variants, and others. This differentiation from current therapies offers a multi-billion dollar opportunity and the potential to reset the standard for patients with BRAF-driven tumors.
In 2024, Fore strengthened its leadership team and continued the execution of its FORTE Master Protocol, a global clinical trial evaluating plixorafenib in distinct patient populations. The trial includes baskets for BRAF V600 Recurrent Primary Central Nervous System (CNS) Tumors, Rare BRAF V600 Mutated Solid Tumors, and Solid Tumors with BRAF Fusions. Fore reported supportive nonclinical data at AACR 2024 and safety and efficacy data at ISPNO 2024 and OCRS 2024, demonstrating plixorafenib's potential across various tumor types.
For 2025, Fore anticipates interim analyses in three monotherapy indications within the FORTE Master Protocol, with the potential for New Drug Application submissions under the Accelerated Approval pathway. The company's lead asset, plixorafenib, has shown single-agent efficacy signals across a variety of tumor types with a manageable safety profile, positioning Fore as a leader in targeted oncology treatments.
