FORE Biotherapeutics Raises $38 Million in Series D-2 Financing
Summary
We are impressed with the teams progress to date, excited about the multiple near term data readouts, and are proud to support the continued advancement of plixorafenib.This financing is a testament to the hard work of our team in developing plixorafenib, a differentiated, rationally designed BRAF inhibitor for both V600 and non V600 mutations that has already generated compelling data to date. We believe plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors, representing a multi-billion-dollar market opportunity, said William Hinshaw, Chief Executive Officer of Fore. With their backing, we are well positioned to continue our capitally efficient execution and make significant strides in delivering the ongoing FORTE Master Protocol as we look to multiple anticipated interim analyses and clinical data supporting potential registration under the accelerated approval pathway with FDA submissions potentially at the end of next year.Proceeds from the financing will be used to advance the registration-intended FORTE Master Protocol, a global Phase 2 clinical trial which includes four sub-protocol baskets evaluating plixorafenib in distinct patient populations. In a previously conducted Phase 1/2 study of adults with advanced solid tumors with BRAF fusions (n=14), plixorafenib monotherapy results in one complete response (with a DOR of 67.4 months), one partial response and 7 stable disease, along with a favorable tolerability profile.AACR 2025: In April 2025, Fore presented new circulating tumor DNA (ctDNA) results from a previously completed plixorafenib clinical trial and presented the basket study design for the ongoing global Phase 2 FORTE clinical trial at the American Association for Cancer Research (AACR) Annual Meeting 2025. Compared to acquired mutations driving resistance to early generation BRAF inhibitors, no new mutations in MAPK pathway genes were found following plixorafenib treatment, supporting the dimerbreaker property and novel mechanism of action of plixorafenib from the early generation BRAF inhibitors.ASCO 2025: At the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 June 3 in Chicago, Fore will present the master protocol design of the ongoing global Phase 2 FORTE clinical trial.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.