On April 26, 2023 FORE Biotherapeutics reported the acceptance of two abstracts on new clinical data related to FORE8394, the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2023, in Chicago and virtually (Press release, Fore Biotherapeutics, APR 26, 2023, View Source [SID1234630575]). The datasets from the phase 1/2a clinical trial, evaluating the safety, tolerability, and efficacy of FORE8394 as a monotherapy will be presented.
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Details of the presentations are as follows:
Oral Presentation
Abstract number: 3006
Title: Safety and efficacy of the novel BRAF inhibitor FORE8394 in patients with advanced solid and CNS tumors: Results from a phase 1/2a study.
Presenter: Macarena de la Fuente, MD, University of Miami Sylvester Comprehensive Cancer Center
Presentation Session Date/Time: The oral presentation will take place on Monday, June 5, 2023, from 8:00 – 11:00 a.m. CDT, during the session titled "Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology."
Poster Presentation
Abstract number: 3106
Title: Dose optimization of novel BRAF inhibitor FORE8394 based on PK and efficacy results.
Presenter: Eric Sherman, MD, Memorial Sloan-Kettering Cancer Center
Presentation Session Date/Time: The poster will be presented on Friday, June 3, 2023, from 8:00 – 11:00 a.m. CDT, during the session titled "Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology."
About FORE8394
FORE8394 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. Preclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors but also disrupts constitutively active dimeric BRAF class 2 mutants, fusions, splice variants and others. Unlike first-generation RAF inhibitors, FORE8394 does not induce paradoxical activation of the RAF/MEK/ERK pathway. As a "paradox breaker," FORE8394 could therefore treat acquired resistance to current RAF inhibitors and, more generally, yield improved safety and more durable efficacy than first-generation RAF inhibitors. The company previously announced interim data from the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and CNS tumors with activating BRAF alterations, providing evidence of durable anti-tumor activity in patients with BRAF-mutated (V600+) cancers. The data were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) in September 2022.