FORE Biotherapeutics, a registration-stage biotherapeutics company focused on developing targeted therapies to treat cancer patients, announced a $38 million Series D-2 financing. For this initial close of the Series D-2, leading healthcare-dedicated investors participated, such as SR One, Medicxi, OrbiMed, HBM Healthcare Investments, Wellington Management, Novartis Venture Fund, Cormorant Asset Management, and 3B Future Health Fund.
This $38 million added to the $75 million raised as part of the earlier Series D and D-1 financings, for an aggregate total of $113 million for this Series D financing.
Fore Bio is anticipating interim analyses to happen this year across three monotherapy indications being evaluated in the FORTE Master Protocol:
1.) BRAF V600 Primary Recurrent CNS Tumors – For this cohort, up to about 50 patients with BRAF V600 primary recurrent CNS tumors will be treated with plixorafenib. And the study’s primary endpoints are overall response rate (ORR) and median duration of response (mDOR). 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. In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated a 67% ORR and a mDOR of 13.9 months, along with a favorable tolerability profile.
2.) Rare BRAF V600 Mutated Solid Tumors – Up to approximately 75 patients with rare BRAF V600 mutated solid tumors will be treated with plixorafenib for this cohort. The study’s primary endpoints are ORR and median duration of response mDOR. And an interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. In a previously conducted Phase 1/2 study of patients with MAPK inhibitor naïve BRAF V600 mutated solid tumors (n=24), plixorafenib monotherapy demonstrated a 42% ORR and a mDOR of 17.8 months, along with a favorable tolerability profile.
3.) Advanced Solid Tumors with BRAF Fusions – For this cohort, up to about 75 patients with advanced solid tumors with non-V600 BRAF fusions will be treated with plixorafenib. The study’s primary endpoints are ORR and median duration of response mDOR. For interim efficacy analysis from the first 25 evaluable patients is anticipated to be conducted in the fourth quarter of 2025. 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 seven stable disease, along with a favorable tolerability profile.
**What the funding will be used for: **The 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. 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.
KEY QUOTES:
“At SR One, our mission is to invest in companies that we believe have the ability to innovate and advance transformational new therapies in areas of high unmet medical need. Fore Bio is focused on resetting the standard in BRAF driven tumors with a potential first in class paradox breaker with compelling early clinical data that support the potential of plixorafenib monotherapy to address the well-known treatment gaps oncologists face with first- and second-generation BRAF inhibitors. We are impressed with the team’s progress to date, excited about the multiple near term data readouts, and are proud to support the continued advancement of plixorafenib.”
Simeon George, M.D., Chief Executive Officer and Managing Partner at SR One
“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. We are grateful for the continued support of this highly regarded investor syndicate and their confidence in both the Fore Bio team and plixorafenib. 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.”
William Hinshaw, Chief Executive Officer of Fore
