On November 10, 2023 FORE Biotherapeutics reported 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 (Press release, Fore Biotherapeutics, NOV 10, 2023, View Source [SID1234637475]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
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 (Free ESMO Whitepaper) 2022, ASCO (Free ASCO Whitepaper) 2023, and SNO 2023 provide evidence of durable anti-tumor single-agent activity in patients with BRAF-mutated cancers.