Fore Biotherapeutics, Inc.

BOSTON--( BUSINESS WIRE )--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced the appointment of Matthew E. Ros as chief operating officer. In his role, Mr. Ros will report to Dan Paterson, president and chief executive officer, and will serve on the company’s executive leadership team. “ We are thrilled to welcome Matt to Verastem Oncology at an important time as we prepare for a mid-2025 product launch and the transition into a commercial-stage company, while we continue to advance our clinical programs,” said Dan Paterson, president and chief executive officer of Verastem Oncology. “ Matt is an accomplished biopharmaceutical executive with extensive experience driving business transformation. His expertise will drive invaluable operational excellence as we prepare to launch a potential first-in-class treatment combination for patients with low-grade serous ovarian cancer, a rare cancer with no approved treatments specifically for this disease, and simultaneously progress programs and partnerships to address cancers driven by the RAS/MAPK-pathway that often lack treatment options.” Mr. Ros brings more than 35 years of commercialization and operational experience in the biopharmaceutical industry with a track record of capital-driving success at publicly traded biopharmaceutical companies undergoing evolutions from early stage to registrational development. Most recently, Mr. Ros served as chief executive officer and board director at FORE Biotherapeutics, an early, clinical-stage oncology company focused on recurrent central nervous system malignancies. Previously, Mr. Ros held executive leadership roles at prominent biopharmaceutical companies, including Epizyme, Sanofi-Genzyme, and ARIAD Pharmaceuticals, where he built fully integrated commercial organizations, delivered strategic collaborations, secured multiple FDA approvals, and supported successful launches. Mr. Ros began his career at Bristol-Myers Squibb where he held positions of increasing responsibility within its Oncology division, contributing to and championing the successful launches of many leading oncology brands. In addition to his executive experience, Mr. Ros serves as a board member at Cogent Biosciences, contributing to its Audit, Nomination, and Governance Committees, and previously served on the Board of Trustees of CancerCARE. “ My life’s work has been focused on fostering the growth and operational strength of companies dedicated to changing cancer and improving the lives of people living with cancer,” said Mr. Ros. “ I am excited to be joining Verastem Oncology to help build on the company’s momentum and create tremendous opportunities for the future while having the potential to bring a meaningful new treatment option to women living with a rare ovarian cancer.” About Verastem Oncology Verastem Oncology (Nasdaq: VSTM) is a late-stage development biopharmaceutical company committed to the development and commercialization of new medicines to improve the lives of patients diagnosed with cancer. Our pipeline is focused on RAS/MAPK-driven cancers, specifically novel small molecule drugs that inhibit critical signaling pathways in cancer that promote cancer cell survival and tumor growth, including RAF/MEK inhibition, FAK inhibition and KRAS G12D inhibition. For more information, please visit www.verastem.com and follow us on LinkedIn .

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today highlighted its recent pipeline achievements and provided its key strategic objectives for 2025. William Hinshaw, Chief Executive Officer of Fore Biotherapeutics, will detail progress and discuss anticipated milestones in a presentation at the 43 rd Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, January 14, 2025, at 5:30 p.m. PT in San Francisco, CA. “ 2025 will be an exciting year at Fore, with multiple value-creating catalysts anticipated in the near-term across our trials. Our focus in 2025 will be continued execution of our differentiated monotherapy development of plixorafenib, which represents a multi-billion dollar opportunity, and the potential for expansion into developing plixorafenib as a combination agent. Plixorafenib’s unique mechanism of action supports the potential to reset the standard for patients with BRAF driven tumors, which have been underserved and underpenetrated due to the limitations of current agents. Plixorafenib is designed to inhibit not only the constitutively active BRAFV600 monomers targeted by first-generation RAF inhibitors, but also disrupt constitutively active dimeric BRAF class II mutants, fusions, splice variants and others, which differentiates it from current approved therapies. We are encouraged by the compelling safety and efficacy profile we have seen and the progress in our registrational trials,” said William Hinshaw, Chief Executive Officer of Fore. 2024 Achievements Strengthened Leadership Team: In 2024, Fore strengthened its leadership team with the appointment of William Hinshaw as Chief Executive Officer, Michael Byrnes as Chief Financial Officer and Payman Darouian, as Senior Vice President, Corporate Development, Strategy and Commercial. The new management team brings extensive experience from large pharmaceutical companies and multiple high-growth, publicly traded biotechnology companies adding to the strong existing capabilities of the team. Continued Execution of FORTE Master Protocol: The FORTE Master Protocol is a global clinical trial which includes baskets evaluating plixorafenib in distinct patient populations. The three monotherapy indications currently under evaluation are BRAF V600 Recurrent Primary Central Nervous System (CNS) Tumors, Rare BRAF V600 Mutated Solid Tumors and Solid Tumors with BRAF Fusions. Advanced Plixorafenib in BRAF V600 Recurrent Primary Central Nervous System Tumors: Continued enrollment in registration-intended basket in up to 50 patients with BRAF V600-mutated recurrent primary CNS tumors. This BOP2 design trial enrolls patients who are naïve to MAPK pathway inhibitor (MAPKi) treatment. Major efficacy endpoints include overall response rate (ORR) and duration of response (DOR). The study builds upon a previous clinical trial of plixorafenib in which six out of nine, or 67%, of MAPKi naïve adults with recurrent BRAF V600-mutated primary CNS tumors demonstrated a partial response (PR) with a median DOR (mDOR) of 13.9 months. Advanced Plixorafenib in Rare BRAF V600 Mutated Solid Tumors: Initiated enrollment in registration-intended basket in up to 75 patients with rare BRAF V600-mutated solid tumors. This BOP2 design trial enrolls patients who are naïve to MAPKi treatment. Major efficacy endpoints include ORR and DOR. The study builds upon a previous clinical trial of plixorafenib in which 42% of MAPKi naïve adults with BRAF V600-mutated solid tumors demonstrated a PR with a mDOR of 17.8 months. Advanced Plixorafenib in Solid Tumors with BRAF Fusions: Continued enrollment in registration-intended basket in up to 75 patients with BRAF fusion advanced solid tumors. This BOP2 design trial enrolls patients with tumors harboring BRAF fusions, excluding those with prior treatment with MAPK inhibitors as well as patients with colorectal or pancreatic ductal adenocarcinoma. The primary endpoint is ORR, as determined by RANO criteria or RECIST v1.1 for primary CNS tumors or other solid tumors, respectively. The study builds upon a previous clinical trial of plixorafenib that demonstrated promising single agent activity including one complete response with a DOR of 66.7+ months, one PR with a DOR of 9.2+ months, and seven stable disease, out of 14 adults evaluable for efficacy. Reported Supportive Nonclinical Data at AACR 2024: Fore reported nonclinical data at AACR 2024 demonstrating that plixorafenib in combination with binimetinib, a MEK inhibitor, is more potent than other BRAF and pan-RAF inhibitors combined with binimetinib, as well as the synergistic activity of plixorafenib with MEK inhibition across all BRAF alterations tested. Reported Supportive Safety and Efficacy Data at International Symposium on Pediatric Neuro-Oncology (ISPNO 2024): Fore reported safety and efficacy data at ISPNO 2024 building on the existing evidence of plixorafenib in children and adults with BRAF-altered recurrent primary CNS tumors. Reported Supportive Safety and Efficacy Data in Ovarian Cancer at 15 th Biennial Ovarian Cancer Research Symposium (OCRS): Fore reported safety and efficacy data at OCRS 2024, including durable partial responses in three out of three patients with BRAF V600-mutated ovarian cancer, who were all heavily pre-treated. 2025 Strategic Objectives and Anticipated Milestones Continued Execution of the FORTE Master Protocol with Interim Analyses in Three Monotherapy Indications Anticipated in 2025 BRAF V600 Primary Recurrent Central Nervous System Tumors: An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the third quarter of 2025. Pending a positive recommendation from the data monitoring committee, topline data from this trial would be anticipated in the second half of 2026. The company anticipates that this trial, with sufficient demonstration of safety and efficacy, would enable the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) under the Accelerated Approval pathway. Rare BRAF V600 Mutated Solid Tumors: An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. Advanced Solid Tumors with BRAF Fusions: An interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. 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; formerly PLX8394) 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. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in FORTE, a global registrational basket trial to support three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn .

PHILADELPHIA--( BUSINESS WIRE )--FORE Biotherapeutics, a registration stage biotherapeutics company dedicated to developing targeted therapies to treat patients with cancer, today announced that William Hinshaw, Chief Executive Officer of Fore Biotherapeutics, will present at the 43 rd Annual J.P. Morgan Healthcare Conference. The presentation will take place on Tuesday, January 14, 2025, at 5:30 p.m. PT at the Westin St. Francis Hotel in San Francisco. Mr. Hinshaw will detail progress and anticipated milestones for Fore’s lead asset, plixorafenib, a novel, small-molecule, next generation, orally available selective inhibitor of mutated BRAF. Plixorafenib is currently being evaluated in a clinical trial with registrational intent in three distinct indications. Please contact Argot Partners to schedule one-on-one meetings with the management team. 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; formerly PLX8394) 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. Plixorafenib has demonstrated single-agent efficacy signals across a variety of tumor types with a manageable safety profile in a Phase 1/2a clinical trial of over 100 patients and is currently enrolling patients in a clinical trial with registrational intent in three distinct indications. For more information, please visit www.fore.bio or follow us on X and LinkedIn .