What Fore Biotherapeutics does

Fore Biotherapeutics is a Philadelphia-based, privately held precision oncology company developing plixorafenib (formerly FORE8394/PLX8394), a next-generation, orally bioavailable small-molecule BRAF inhibitor designed to address limitations of first-generation RAF inhibitors. The drug is engineered with a dual mechanism: a paradox-breaker that avoids the paradoxical MAPK reactivation seen with vemurafenib/dabrafenib, and a BRAF-specific dimer-breaker that selectively inhibits constitutively active dimeric BRAF class II mutants, fusions, and splice variants — while sparing RAF signaling in normal cells. This architecture enables single-agent activity without the MEK-inhibitor co-administration that characterizes current standard of care, with a less-than-2% drug-related discontinuation rate and a median duration of response of 17.8 months in MAPKi-naïve BRAF V600 solid tumors.

The company's sole clinical program is the global, registration-intended Phase 2 FORTE Master Protocol (NCT05503797), which evaluates plixorafenib monotherapy across multiple basket sub-protocols targeting distinct BRAF-altered populations: recurrent primary CNS tumors (including high-grade glioma, the basis of the recent BTD), rare BRAF V600 solid tumors, and BRAF fusion-positive solid tumors, with thyroid cancer as an additional emerging indication. FDA has granted three concurrent designations to plixorafenib: Breakthrough Therapy Designation (April 2026, first ever for a targeted therapy in HGG), Fast Track Designation, and Orphan Drug Designation for CNS malignancies. The asset has shown an 85% reduction in V600E mutant allele frequency in ctDNA after one cycle and a 67% ORR in MAPK inhibitor-naïve BRAF V600 primary recurrent CNS tumors.

Fore operates as a virtual biotech with expertise distributed across the United States and an 11-50 employee base, backed by $113M in cumulative Series D financing from SR One, Medicxi, OrbiMed, HBM Healthcare Investments, Wellington Management, Novartis Venture Fund, Cormorant Asset Management, and 3B Future Health Fund. The company is pre-revenue and anticipates filing an NDA under the FDA's Accelerated Approval pathway pending positive Phase 2 topline results expected in 2H 2026. The 2024 installation of a commercial-experienced leadership team (CEO Hinshaw ex-Novartis US Oncology, CFO Byrnes ex-eFFECTOR, SVP Darouian ex-BMS) signals active preparation for either a direct launch or a partnership / acquisition transaction upon regulatory success.

Name

Fore Biotherapeutics

Legal name

Fore Biotherapeutics US Inc.

Website

https://fore.bio

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

Fore Biotherapeutics is a Philadelphia-based virtual biotech developing plixorafenib, a next-generation BRAF inhibitor for BRAF-altered cancers. The company is registration-stage, pre-revenue, and pursuing FDA Accelerated Approval for plixorafenib across CNS, rare solid tumor, and fusion-positive cancer indications.

Ownership category

akta.pro rank

Product category

Precision Oncology Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Drug Discovery (Target ID/Validation & Hit Discovery) (HLAIALAA)

Keywords

• Precision oncology therapeutics
• Targeted cancer therapy
• BRAF inhibitor development
• Oncology drug development
• Clinical-stage biotherapeutics

Headquarters

HQ city

Philadelphia

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. Plixorafenib commercialization: Pre-revenue company. Fore Biotherapeutics is a registration-stage biotherapeutics company developing plixorafenib for cancer treatment. The company anticipates submitting a New Drug Application (NDA) to the FDA under the Accelerated Approval pathway pending positive trial results. Revenue will be generated through pharmaceutical product sales upon regulatory approval.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Fore Biotherapeutics is developing plixorafenib, an investigational next-generation orally available small-molecule BRAF inhibitor designed to inhibit a wide range of BRAF gene alterations in cancer cells, including V600 and non-V600 mutations, class II mutants, fusions, and splice variants. The drug is being advanced through the global FORTE Master Protocol Phase 2 registration-intended clinical trial for patients with BRAF-altered solid tumors who have exhausted prior therapies.

Product overview

Fore Biotherapeutics is a registration-stage precision oncology company developing targeted therapies for patients with hard-to-treat cancers. The company's sole product in development is plixorafenib (formerly FORE8394, PLX-8394), a next-generation BRAF inhibitor designed as a first-in-class paradox breaker and BRAF-specific dimer-breaker. Plixorafenib targets both V600 and non-V600 BRAF mutations, including Class I and II mutations, fusions, and splice variants. The drug is currently in a global Phase 2 registration-intended clinical trial called FORTE Master Protocol (NCT05503797) evaluating four sub-protocol baskets across distinct patient populations including BRAF V600 primary CNS tumors, rare BRAF V600 mutated solid tumors, and solid tumors with BRAF fusions.

Differentiator

Problem solved

Functional benefit

Brands

• Plixorafenib: Lead program - an investigational, next-generation BRAF inhibitor designed to inhibit a wide range of BRAF gene alterations in cancer cells. Also known as FORE8394 and PLX8394. FDA has granted Orphan Drug designation for primary brain and CNS malignancies, Fast Track designation for BRAF Class 1 (V600) and Class 2 (including fusions) alterations, and Breakthrough Therapy Designation for BRAF V600E-mutated high-grade glioma.
• FORTE Master Protocol

Products and services

• Plixorafenib (FORE8394, formerly PLX8394) Plixorafenib is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It is a paradox-breaker and BRAF-specific dimer-breaker designed to inhibit a wide range of BRAF gene alterations in cancer cells, including V600 monomers, non-V600 mutations, class II mutants, fusions, and splice variants, while sparing wild-type RAF function in normal cells. The drug is intended for patients with BRAF-altered solid tumors who have exhausted prior therapies.
• Expanded Access Program (Compassionate Use) Fore Biotherapeutics may consider providing plixorafenib through an Expanded Access (compassionate use) program for patients with BRAF-mutated tumors who are not eligible to participate in clinical trials and have no other treatment options, administered under physician supervision.

Quantifiable outcome

• 67% overall response rate (ORR) in MAPK inhibitor-naïve BRAF V600 primary recurrent CNS tumors (n=9)
• +4 more outcomes

Named customers1 record

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core and key.

• Memorial Sloan Kettering Cancer CentercoreStrategic or Co-development PartnerKey clinical trial site and collaboration. Eric Sherman, M.D. from Memorial Sloan Kettering serves as Principal Investigator and Head and Neck Medical Oncologist for the FORTE Phase 2 plixorafenib study. Dr. David Solit from MSKCC serves on Fore's Scientific Advisory Board.
• University of Miami Sylvester Comprehensive Cancer CentercoreStrategic or Co-development PartnerKey clinical trial site. Macarena De La Fuente, M.D., Chief of Neuro-Oncology, serves as Lead CNS Investigator for the Phase 1/2a and FORTE Phase 2 plixorafenib clinical studies.
• Dana-Farber Cancer InstitutekeyStrategic or Co-development PartnerKey opinion leader collaboration. Patrick Y. Wen, M.D., Director, Center for Neuro-Oncology, participated in Fore's KOL roundtable discussion on plixorafenib's potential.
• Johns Hopkins University Sidney Kimmel Comprehensive Cancer CenterkeyStrategic or Co-development PartnerClinical trial site. Karisa Schreck, M.D., Ph.D. from Johns Hopkins presented the FORTE Master Protocol design at ASCO 2025.

Scale indicators5 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Day One Biopharmaceuticals: Day One markets tovorafenib (Ojemda), an FDA-approved BRAF inhibitor for pediatric BRAF-altered low-grade glioma. Most directly comparable peer given shared BRAF-targeted oncology focus and CNS-tumor positioning; Fore's BTD in high-grade glioma is a logical expansion adjacency to Day One's pediatric franchise.
• Black Diamond Therapeutics: Precision oncology company developing small-molecule targeted therapies against allosteric and oncogenic mutations, including BRAF and MAPK-pathway programs. Closely comparable on therapeutic area, mutation-agnostic discovery approach, and clinical-stage modality.
• Erasca: Clinical-stage precision oncology company focused exclusively on the MAPK pathway, with a pipeline of inhibitors targeting RAF, MEK, ERK, and SHP2. Highly comparable business model as a single-pathway-focused precision oncology company targeting BRAF/MEK/ERK escape mechanisms.

Emerging players

• Relay Therapeutics: Clinical-stage precision oncology company using motion-based drug design to develop targeted therapies, including MAPK-pathway programs. Comparable on precision-oncology positioning and clinical-stage targeted modality.
• Cogent Biosciences: Clinical-stage precision oncology company developing targeted therapies for genomically defined cancers. Comparable as a small-cap, mutation-targeted oncology peer with a single dominant asset advancing through pivotal trials.
• PMV Pharmaceuticals: Clinical-stage precision oncology company developing small-molecule reactivators of mutant p53. Comparable as a small-cap, clinical-stage targeted oncology peer advancing a single dominant mechanism.

Broad incumbents

• Pfizer: Acquired Array BioPharma (developer of BRAF/MEK inhibitor combinations) and recently gained tovorafenib through Day One. A core BRAF competitive incumbent and likely M&A counterparty given history of acquiring next-generation BRAF assets.
• Novartis: Sells dabrafenib (Tafinlar), the leading first-generation BRAF inhibitor, typically combined with trametinib. Fore's CEO previously led Novartis U.S. Oncology, and Novartis Venture Fund is a Fore investor, underscoring the competitive and strategic relationship.
• Roche (Genentech): Markets vemurafenib (Zelboraf), the first FDA-approved BRAF V600E inhibitor for melanoma. A direct therapeutic-area competitor with entrenched market position and large commercial reach that Fore's next-generation compound would have to displace.

Others

• Plexxikon (Daiichi Sankyo): Originated PLX8394 (now plixorafenib/FORE8394), the asset Fore in-licensed and developed. The historical developer of vemurafenib and a related chemistry platform; an enabling technology antecedent rather than active commercial competitor.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key highlights6 records

Customer concentration

• Xx.com/forebiotx
• LinkedInlinkedin.com/company/forebiotherapeutics

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds11 records

Investors20 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fore Biotherapeutics