Fore Biotherapeutics to Present Phase 1/2a Data on FORE8394, a Next-Generation BRAF Inhibitor, at ESMO 2022

The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations.

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Tuesday, August 9, 2022
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Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Genomics, ESMO, RAF, CNS, European Society for Medical Oncology, Fore, Cancer, Neoplasm, Patient, Twitter, Development of the human body, Safety, Drug development, BRAF, V600, LinkedIn, Pharmaceutical industry
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Summary
Key Points: 
  • The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations.
  • Details for the presentation are as follows:
    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.
  • Lead asset FORE8394 is a Class I/II BRAF inhibitor with demonstrated clinical safety and early efficacy signals in an ongoing Phase 1/2a clinical trial.


Fore Biotherapeutics, a precision oncology company developing treatments for patients with genetically defined cancers whose current treatment options are limited, today announced that data from the ongoing Phase 1/2a study of lead asset, FORE8394, will be presented in the Developmental Therapeutics poster session at the European Society of Medical Oncology Congress (ESMO) taking place in Paris, France, September 9-13, 2022.

The Phase 1/2a open-label study is assessing FORE8394, a next-generation BRAF inhibitor, in patients with advanced solid and CNS tumors with activating BRAF alterations. The poster presentation will report interim analysis in adults (≥18 years) with V600+ advanced solid & central nervous system tumors, including patients who have not previously received BRAF targeted treatment. FORE8394 is a novel, differentiated BRAF inhibitor that uniquely targets Class 1 (V600) and Class 2 alterations, including fusions, and does not induce paradoxical activation of the RAF/MEK/ERK pathway, a limitation of the current standard of care.

Details for the presentation are as follows:

Title: Efficacy of BRAF Inhibitor FORE8394 in BRAF V600+ Patients

Abstract #: 2098

Presentation #: 466P

Presenter: Eric J. Sherman, Memorial Sloan Kettering Cancer Center

Date: Monday, September 12, 2022

Time: 12:00 -13:00 CEST

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 II 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

About Fore Biotherapeutics

Fore Bio is a clinical-stage precision oncology biotechnology company focused on developing treatments for patients with genetically defined cancers whose current treatment options are limited. Lead asset FORE8394 is a Class I/II 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.

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