PHILADELPHIA–(BUSINESS WIRE)–FORE Biotherapeutics today announced 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) Annual Meeting, taking place June 3-7, 2023, in Chicago and virtually. The datasets from the phase 1/2a clinical trial, evaluating the safety, tolerability, and efficacy of FORE8394 as a monotherapy will be presented.
“Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology.”
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 Congress (ESMO) in September 2022.
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 FORE8394 is a Class 1/V600 and 2 BRAF inhibitor with demonstrated clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial. Leveraging a proprietary functional genomics platform that can screen a wide range of known mutations for cancer-driving genes, the Fore R&D 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.
Contacts
Investors and Media:
Argot Partners
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