FORE Biotherapeutics today announced an oral presentation highlighting updated Phase 1/2a clinical data for plixorafenib (FORE8394; PLX8394), the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations, will be given at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, taking place November 15-19, 2023, in Vancouver, Canada. The data being presented continue to demonstrate that plixorafenib has a favorable safety profile and results in durable responses in adults with primary central nervous system tumors with BRAF V600 alterations.

Details for the SNO 2023 Oral Presentation:

Title: Efficacy of BRAF inhibitor plixorafenib (FORE8394) in recurrent, primary central nervous system tumors (PCNST)

Presenter: Macarena I. de la Fuente, MD, University of Miami, Sylvester Comprehensive Cancer Center

Abstract number: CTNI-76

Session: Clinical Trials – Non-immunologic

Presentation date and time: Friday, Nov 17, 2023, 3:55-4:05 p.m. PT

About Plixorafenib (FORE8394)

Plixorafenib is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Nonclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAF V600 monomers targeted by first-generation BRAF inhibitors but also disrupts constitutively active dimeric non-V600 BRAF alterations (class 2 mutants, fusions, splice variants and others). Unlike first- and second-generation BRAF inhibitors, plixorafenib does not induce paradoxical activation of the MAPK pathway. This not only yields the potential for an improved safety profile, but also avoids the need to combine with a MEK inhibitor. As a “paradox breaker,” plixorafenib could therefore yield improved safety and more durable efficacy than earlier generation BRAF inhibitors and have activity in settings of acquired resistance to current RAF inhibitors.

Plixorafenib is currently being evaluated in Phase 1/2a clinical trial in adults and children with advanced solid tumors (including brain and spinal cord tumors) with activating BRAF alterations. Interim clinical data presented at ESMO 2022, ASCO 2023, and SNO 2023 provide evidence of durable anti-tumor single-agent activity in patients with BRAF-mutated cancers.

About Fore Biotherapeutics

Fore Bio is a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients. Its lead asset plixorafenib (FORE8394) is a V600 and non-V600 BRAF inhibitor with manageable clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial. The Fore Bio research and development team is optimizing drug development by identifying existing compounds with known clinical profiles and a clear path through clinical development to advance new medicines for patients without treatment options. For more information, please visit www.fore.bio or follow us on Twitter and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231110438808/en/