On September 28, 2022 Fore Biotherapeutics (Fore Bio), a precision oncology company dedicated to developing innovative treatments that provide a better outcome for cancer patients, reported 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 (Press release, Fore Biotherapeutics, SEP 28, 2022, View Source [SID1234621504]).
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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 (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper) 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 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.