FORE Biotherapeutics has successfully raised $67.4 million to support the development of its lead targeted anti-cancer drug, plaxiorafenib. This funding round was co-led by SR One, Medicxi, and SymBiosis, and also attracted new investors, including TaiAx, LG Technology Ventures, Primer Ventures, and Axil.
Previous Investor Participation
Previously invested companies such as OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung, and 3B Capital also participated in the deal. Thanks to this new round, the total capital raised in Series D-2 reached $110 million. The Philadelphia-based firm focuses on developing targeted treatments for patients with types of cancer that are often difficult to treat.
Plans for Fund Utilization
President and CEO William Hinshaw stated that the additional funds will allow the company to successfully pass key clinical and regulatory milestones over the next few years to advance plaxiorafenib to more advanced stages of development. The funds are planned to be directed towards continuing the late-stage development of plaxiorafenib, also known as FORE8394.
Research and Regulatory Goals
The company has completed patient enrollment in the global FORTE study, which covers recurrent or progressive central nervous system tumors with the BRAF V600E mutation. Preliminary results from this study are expected by the end of 2026, and if favorable, the company aims to file for accelerated approval with the FDA in 2027. Previously, the FDA granted plaxiorafenib Breakthrough Therapy designation in April 2026.
Expansion of Clinical Program
The therapy is being evaluated in patients with BRAF-altered tumors, including certain types of brain and spinal cord cancer. Furthermore, the company continues to develop monotherapies in additional indications, targeting rare solid tumors with the BRAF V600 mutation and common solid tumors with BRAF fusions. The FORTE study is a global Phase 2 trial designed to evaluate plaxiorafenib in various patient groups. The company recently received approval to include patients aged eight and older in the study, expanding access for children and young adults with specific BRAF-altered CNS tumors. The dosing regimen was also updated to allow plaxiorafenib to be taken with food, eliminating the need for an additional pharmacokinetic boost previously used in the trial. According to the company, drug-related discontinuation remained below 2% across all tumor types.
Prospects and Oncology Market
Earlier studies have demonstrated encouraging activity of the drug. In a Phase 1/2 study with patients having recurrent primary CNS tumors with BRAF V600 who had not previously received MAPK inhibitors, plaxiorafenib showed significant response rates and a favorable safety profile. FORE Biotherapeutics positions plaxiorafenib as a next-generation BRAF inhibitor designed to address limitations associated with earlier treatment methods. The company asserts that its approach can reduce recurrence rates and decrease the need for combination therapies used with older BRAF drugs. This deal reflects sustained interest in the growing market of precision oncology—treatments tailored to individuals with specific genetic mutations. BRAF mutations occur in several types of cancer and remain a focus for drug manufacturers.