Fore Biotherapeutics Announces Fast Track Designation Granted by FDA to FORE8394 for the Treatment of Cancers Harboring BRAF Class 1 and Class 2 Alterations

• FORE8934 currently being evaluated in Phase 1/2a trial for the treatment of advanced solid and CNS tumors with BRAF alterations
• Company plans to initiate global Phase 2 study in 4Q 2022

Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to FORE8934, its investigational, novel, small-molecule, orally available inhibitor for the treatment of patients with cancers harboring BRAF Class 1 (V600) and Class 2 (including fusions) alterations who have exhausted prior therapies.

The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. A drug that receives Fast Track designation may become eligible for Accelerated Approval, Priority Review, or Rolling Review if relevant criteria are met.

“The FDA's Fast Track Designation for FORE8394 underscores the urgent need faced by patients with advanced BRAF-muted cancers who have no other options,” said Stacie Shepherd, M.D., Ph.D., Chief Medical Officer of Fore Biotherapeutics. “This designation will help us expedite our program as we advance toward our goal of addressing this area of high unmet need, including the anticipated initiation of our global Phase 2 trial in the fourth quarter. We look forward to continuing to work closely with the FDA as we explore the potential for FORE8394 to improve outcomes for patients with these life-threatening cancers.”

The company previously announced interim data from the ongoing Phase 1/2a clinical trial evaluating FORE8394 in advanced solid and central nervous system (CNS) tumors with activating BRAF alterations, presented at the European Society of Medical Oncology Congress (ESMO) earlier this month, providing evidence of durable anti-tumor activity in patients with BRAF-mutated (V600+) cancers.

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 BRAF^V600 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.

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 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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