FORE Biotherapeutics to Present New Clinical and Preclinical Plixorafenib Data at Upcoming Oncology Medical Meetings

SNO 2026: Presenting updated long-term efficacy and safety data from Phase 1/2a study evaluating plixorafenib in patients with BRAF V600 primary CNS tumors

ENA 2026: Presenting new preclinical data demonstrating plixorafenib’s mechanism of action and potential in BRAF-altered colorectal cancer

PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced two abstracts that have been selected for presentation at two prestigious oncology medical meetings. The first is an oral presentation highlighting long-term efficacy and safety data from a Phase 1/2a study evaluating plixorafenib in patients with BRAF V600 primary CNS tumors and will be presented at the upcoming Society for Neuro-Oncology (SNO) 2026 Annual Meeting taking place in Philadelphia November 12-15, 2026. The second is a poster presentation featuring new preclinical data supporting plixorafenib’s unique mechanism of action and its potential as a future treatment for BRAF-altered colorectal cancer (CRC) and will be presented at the 38^th EORTC-NCI-AACR Symposium (ENA 2026) taking place in Barcelona November 18-20, 2026.

Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore, commented: “The data being presented at SNO this year are exciting because they show that plixorafenib has sustained response and activity in patients with BRAF-altered CNS tumors, including treatment durations exceeding 4 years, with a manageable safety profile with no cumulative or late-onset toxicities, and without the class-associated adverse events commonly observed with first generation RAF inhibitors.”

“BRAF V600 mutation occurs in approximately 8% of colorectal cancer and is a highly aggressive tumor with poor prognosis due to limited responses and intrinsic and acquired resistance. As a novel paradox and dimer breaker BRAF inhibitor, we believe plixorafenib’s unique mechanism of action has the potential to be the ideal combination partner to mitigate resistance in colorectal cancer. At ENA this year, we will be presenting new preclinical data that demonstrates single-agent plixorafenib activity following standard therapies, along with compelling synergistic efficacy in vitro when combined with pan-RAS inhibition or widely used standard-of-care agents, including in resistant cell lines. We look forward to sharing all of these data with the scientific and medical communities later this month,” concluded Dr. Peacock.

Oral Presentation Details at SNO 2026:

Title: Long-term safety and efficacy of plixorafenib in patients with BRAF-altered CNS neoplasms from the phase 1/2a PLX120-03 study
Presenter: Macarena De La Fuente, M.D., Sylvester Comprehensive Cancer Center, University of Miami
Abstract Number: CTNI-09
Session: Clinical Trials Oral Abstracts Session I
Date and Time: Friday, November 13, 2026, 10:54 – 10:59 a.m. ET

Poster Presentation Details at ENA 2026:

Title: Determinants of response and rational combination strategies for plixorafenib (PLX8394/FORE8394) in models of BRAF-altered colorectal cancer
Lead Author: Jessica Jang, Ph.D., Director, Translational Science, Fore Biotherapeutics
Poster Number: PB-117
Poster Session: Molecular Targeted Agents
Date and Time: Thursday, November 19, 2026, 1:00 – 3:00 p.m. CET

About Plixorafenib

Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. Plixorafenib received Breakthrough Therapy Designation by the U.S. Food and Drug Administration in April 2026. In a previously conducted Phase 1/2 study in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations and tolerability challenges of currently available BRAF inhibitors, including high rates of rash, hemorrhage and growth effects in younger patients, through its unique mechanism of action targeting both BRAF Class I and Class II alterations, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor.

About FORE Biotherapeutics

Fore is a registration stage targeted oncology company dedicated to developing innovative treatments that provide better outcomes for patients with the hardest-to-treat cancers. The Company’s lead asset plixorafenib (FORE8394 or PLX-8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1^st and 2^nd generation BRAF inhibitors. For more information, please visit www.fore.bio or follow us on X and LinkedIn.