PHILADELPHIA, PA — FORE Biotherapeutics recently completed a $38 million Series D-2 financing round, bringing the total raised as part of the Series D to an impressive $113 million. This latest funding round was backed by leading healthcare investors, including SR One, Medicxi, OrbiMed, HBM Healthcare Investments, and Novartis Venture Fund, reflecting strong confidence in the company’s innovative approach to cancer treatment.
The proceeds will primarily support the advancement of plixorafenib, FORE’s groundbreaking BRAF inhibitor, as part of its registration-focused FORTE Master Protocol. Designed for patients with high unmet medical needs, the Phase 2 global clinical trial evaluates plixorafenib across three monotherapy indications, paving the way for potential FDA submissions under the Accelerated Approval pathway.
“At SR One, our mission is to invest in companies capable of advancing transformational therapies,” said Simeon George, M.D., CEO and Managing Partner at SR One. “Plixorafenib shows compelling clinical potential to address significant treatment gaps in BRAF-driven tumors, and we are proud to support FORE as it works toward redefining care standards.”
FORE’s CEO, William Hinshaw, emphasized the importance of this milestone in driving their strategic goals. “This financing is a testament to the hard work of our team in developing plixorafenib as a differentiated, rationally designed BRAF inhibitor for both V600 and non-V600 mutations,” he noted. “With such compelling early data, the potential of plixorafenib represents a multi-billion-dollar market opportunity. This investment enables us to accelerate execution of the FORTE Master Protocol and achieve critical milestones.”
Strategic plans for 2025 include interim analyses for three study cohorts addressing BRAF V600 recurrent CNS tumors, rare BRAF V600 solid tumors, and advanced tumors with non-V600 BRAF fusions. Based on positive data, the company aims to advance toward FDA submissions by late 2026. Key highlights from earlier trials demonstrated promising objective response rates (ORR), with plixorafenib showing a favorable tolerability profile.
FORE’s recent presentation at AACR 2025 further underscored the potential of plixorafenib, with findings supporting its novel mechanism of action and the viability of circulating tumor DNA as a disease monitoring marker. Additional insights will be shared in late May at the American Society of Clinical Oncology (ASCO) Annual Meeting.
With robust investor backing and a clear path to regulatory submissions, FORE Biotherapeutics is well-positioned to transform the landscape of targeted cancer treatments and deliver innovative solutions to patients worldwide.
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