A Trial to Evaluate Deoxyribonucleic) in BRAF (V-raf Murine Sarcoma Viral Oncogene Homolog B1)-Altered Glioma During Treatment With Plixorafenib Alone or With Retifanlimab

The investigators will evaluate the sensitivity of ctDNA from plasma and CSF at baseline (defined as C1D1) and over time in response to treatment with plixorafenib alone or in combination with retifanlimab in patients with BRAF-V600E mutant glioma refractory to prior therapies.

Start Date07 Apr 2025

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+3]

NCT06385119

/ CompletedPhase 1

A Phase 1, Open-Label, 2-Part, Single Dose, Crossover Study to Examine the Effect of Food and Cobicistat Administration on the Pharmacokinetics and Safety of Plixorafenib in Healthy Participants.

The primary goal of this phase 1 study is to evaluate the effect of food and cobicistat on the pharmacokinetics of plixorafenib in healthy participants. Healthy male and female participants between the ages of 18 and 55 will be enrolled into this study. This study is looking to examine the following in two parts:
Part A
* The effect of food on the single dose PK of plixorafenib administered with cobicistat.
* The effect of cobicistat administration on the single dose PK of plixorafenib.
* The safety of plixorafenib administered alone and with cobicistat in a single dose regimen in healthy participants.
Part B
* To examine the effect of a high-fat and a low-fat meal versus fasted state on the single dose PK of plixorafenib administered alone.
* To examine the effect of a low-fat meal versus fasted state on the single dose PK of plixorafenib administered with cobicistat.
* To determine the safety of plixorafenib administered alone or with cobicistat (low-fat meal only) in a single dose regimen.

Start Date24 Apr 2024

Sponsor / Collaborator

Fore Biotherapeutics, Inc.

NCT05503797

/ RecruitingPhase 2

A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394, an Inhibitor of BRAF Class 1 and Class 2 Alterations, in Participants With Cancer Harboring BRAF Alterations

The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive primary central nervous system (CNS) tumors, including rare BRAF V600E-mutated solid tumors, including anaplastic thyroid, ovarian, cholangiocarcinoma or other rare cancers.

Start Date21 Feb 2023

Sponsor / Collaborator

Fore Biotherapeutics, Inc.

100 Clinical Results associated with Plixorafenib

100 Translational Medicine associated with Plixorafenib

100 Patents (Medical) associated with Plixorafenib

Literatures (Medical) associated with Plixorafenib

01 Mar 2026·NEOPLASIA

Inhibition of fatty acid synthase enhances therapeutic efficacy and delays acquired resistance to BRAF-targeted therapy in colorectal cancer

Article

Author: Kolesar, Jill M ; Baca, Yasmine ; Rock, Stephanie ; Wang, Chi ; Tessmann, Josiane W ; Zaytseva, Yekaterina Y ; Beswick, Ellen J ; Kelson, Courtney O ; He, Daheng ; Geisen, Mariah E ; Faisal, Abu Saleh Mosa

The presence of BRAF^V600E mutations is associated with poor prognosis in colorectal cancer (CRC). Although the FDA-approved combination of encorafenib and cetuximab provides clinical benefit in this population, only 22% of patients respond and most eventually develop resistance. This study investigated the mechanisms of resistance to PLX8394, a second-generation BRAF inhibitor. Using primary and established BRAF^V600E CRC cells, we show that the development of resistance to PLX8394 results in cross-resistance of cells to encorafenib. Moreover, the acquired resistance is associated with increased proliferation, invasion, and upregulation of lipid metabolism, including increased expression of fatty acid synthase (FASN), a key enzyme of lipid synthesis. Yet, the combination of PLX8394 and FASN inhibitor TVB3664 has a synergistic effect on cell viability and colony formation in parental CRC cells, but not in PLX-resistant cells. Importantly, we demonstrate that addition of TVB3664 to the PLX8394 or encorafenib regimen significantly postpones development of resistance to BRAF-targeted therapy by inhibiting the cell cycle progression via a decrease in pRb (Ser780) and downregulation of E2F transcription factor and Cyclin D1 expression. Consistently, clinical data show that patients with BRAF^V600E CRC who have high FASN expression in tumor tissues have higher expression of cell cycle-associated genes, including CDKs, E2F, CCDN1 (Cyclin D1), survivin, and MKI67. Collectively, these findings identify FASN-driven lipid metabolism as a critical mediator of resistance to BRAF-targeted therapy and suggest that incorporation of FASN inhibitors may enhance therapeutic efficacy and delay acquired resistance in BRAF^V600E CRC.

01 Oct 2025·JCO Precision Oncology

Sustained Response to Pan-BRAF Inhibitor Plixorafenib (FORE8394, PLX8394) in a Young Adult With Neurodegenerative Langerhans Cell Histiocytosis

Article

Author: Shepherd, Stacie Peacock ; Zinn, Daniel ; Scull, Brooks ; McClain, Kenneth ; Armstrong, Terry ; Velazquez, Jessica ; Desai, Nilesh ; Yi, Joanna S. ; Allen, Carl ; Mazur, Kate ; Kudlaty, Rebecca ; McCarthy, Kathleen S.

29 May 2025·SCIENCE

BRAF oncogenic mutants evade autoinhibition through a common mechanism

Article

Author: Sahmi, Malha ; Lavoie, Hugo ; Hwa Jo, Chang ; Jin, Ting ; Tripathy, Sasmita ; Gendron, Patrick ; Maisonneuve, Pierre ; Rice, William J. ; Marinier, Anne ; Wang, Bing ; Decossas, Marion ; Therrien, Marc ; Lajoie, Driss ; Schuetz, Doris A. ; Beaulieu, Pierre ; Weber, Sandra ; Schriemer, David C. ; Arseneault, Geneviève ; Filandr, Frantisek

Uncontrolled activation of the rat sarcoma (RAS)–extracellular signal–regulated kinase (ERK) pathway drives tumor growth, often because of oncogenic BRAF mutations. BRAF regulation, involving monomeric autoinhibition and activation by dimerization, has been intensely scrutinized, but mechanisms enabling oncogenic mutants to evade regulation remain unclear. By using cryo–electron microscopy, we solved the three-dimensional structures of the three oncogenic BRAF mutant classes, including the common V600E variant. These mutations disrupted wild-type BRAF's autoinhibited state, mediated by interactions between the cysteine-rich domain and kinase domain, thereby shifting the kinase domain into a preactivated conformation. This structural change likely results from helix αC displacement. PLX8394, a BRAF inhibitor that stabilizes helix αC in an inactive conformation, restored the autoinhibited conformation of oncogenic BRAF, explaining the properties of this class of compounds.

News (Medical) associated with Plixorafenib

08 Jul 2026

·firstwordpharma.com

Biopharma bites: Job cuts at Novartis, fresh funding for MeiraGTx and Fore, plus Boehringer's latest deal

Novartis adds 322 jobs to NJ layoff tallyMeiraGTx gets $400M infusion for gene therapy trioFore fields a further $67.4M in series D funding Boehringer inks cancer vaccine licensing deal Novartis adds 322 jobs to NJ layoff tallyNovartis is planning another round of job cuts at its US headquarters in East Hanover, New Jersey, which will eliminate 322 positions in October. The latest reduction, disclosed in a state Worker Adjustment and Retraining Notification (WARN) filing, is the company's fourth round of layoffs at the site this year — 114 cuts were posted in March, 60 in April and 76 in May — and brings the total number of announced East Hanover job cuts in 2026 to 572. All cuts will go into effect by year-end (see – Vital Signs: Largest layoffs of the first quarter)."Novartis continually evaluates opportunities to align our organisation with evolving patient, customer and business needs," a Novartis spokesperson told FirstWord in an email. "As part of this, we are making changes across our field sales, patient support and marketing organisations to enhance operational efficiency and ensure we are investing resources where they can have the greatest impact."The company recently announced plans to build a new facility in North Carolina focused on the manufacturing of active pharmaceutical ingredients. That marked the seventh and final site under its $23-billion commitment to expand its US footprint.-Anna BratulicMeiraGTx gets $400M infusion for gene therapy trioOberland Capital Management will invest up to $400 million in gene therapy developer MeiraGTx, comprising up to $375 million in non-dilutive cash and up to $25 million in equity. In exchange, Oberland will receive low single-digit capped royalties on a trio of gene therapies: botaretigene sparoparvovec (bota-vec), which has completed Phase III testing for X-linked retinitis pigmentosa; AAV2-hAQP1, a treatment for grade 2/3 late radiation-induced xerostomia in the pivotal Phase II AQUAx2 study; and AAV-AIPL1, a one-time therapy for the rare inherited retinal disorder Leber congenital amaurosis 4. While J&J had been developing bota-vec thanks to a 2023 deal, the pharma in April sold global rights to the programme back MeiraGTx for $25 million upfront. Meanwhile, Eli Lilly paid $75 million upfront for exclusive, worldwide rights to AAV-AIPL1."MeiraGTx is in the rare position of having three potentially approvable therapies within the next 12 to 24 months, two of which have significant commercial potential," said Michael Bloom, a partner at Oberland Capital. "Each of these would be first to market in areas of complete unmet need where there are a large number of patients waiting for these potential treatments. -Elizabeth EatonFore fields a further $67.4M in series D fundingFore Biotherapeutics raised $67.4 million in a series D-2 extension Tuesday, bringing the round's total to $110 million. The financing was co-led by SR One, Medicxi and SymBiosis, with participation from new investors TaiAx, LG Technology Ventures, Primer Ventures and Axil, as well as existing backers including OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung and 3B Capital. The capital will go towards the development of plixorafenib, a BRAF inhibitor in the Phase II FORTE basket study involving patients with BRAF V600E primary central nervous system (CNS) tumours, solid tumours with BRAF fusions, and rare BRAF V600 mutated solid tumours.Topline data from the CNS tumour basket are due by year-end, and if positive, Fore plans to file for accelerated FDA approval of plixorafenib in 2027. -Elizabeth EatonBoehringer inks cancer vaccine licensing dealBoehringer Ingelheim has struck a deal to tap into Prime Vector Technologies' Orf virus (ORFV) platform, giving the German drugmaker access to a viral vector system that could support the next generation of off-the-shelf cancer vaccines. Financial terms weren't disclosed, but Prime Vector said it is eligible for an upfront payment, as well as development, regulatory and commercial milestones, plus royalties on future product sales.The agreement includes the assignment of certain patents and an exclusive license to use the ORFV platform. Boehringer plans to evaluate the technology both as a standalone cancer vaccine and in combination with assets from its existing oncology pipeline.Prime Vector was founded in 2019 as a spin-off from the University of Tübingen. "Having successfully advanced the platform from preclinical research through GMP manufacturing and Phase I/IIa clinical evaluation in infectious diseases, we are excited to further explore its potential in oncology," stated CEO Ralf Amann.-Anna Bratulic

VaccineLicense out/inPhase 2Phase 3

07 Jul 2026

·www.businesswire.com

FORE Biotherapeutics Announces Closing of Upsized $67.4 Million Series D-2 Extension Financing and Highlights Recent Plixorafenib Achievements

PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics, a registration stage company dedicated to developing targeted therapies to treat patients with cancer, today announced the closing of an upsized Series D-2 extension financing of $67.4 million, bringing the total Series D-2 amount raised to $110 million. The financing was co-led by SR One, Medicxi, and SymBiosis and supported by a syndicate of new investors, including TaiAx, LG Technology Ventures, Primer Ventures and Axil, and all existing investors, including OrbiMed Advisors, HBM Healthcare Investments, Wellington Management, Cormorant Capital, Novartis Venture Fund, Windham Life Science Partners, Samsung and 3B Capital. Proceeds from the financing will be used to support the ongoing late-stage development of plixorafenib, including delivering on the topline data from the recurrent or progressive BRAF V600E primary CNS tumor basket of the FORTE study around the end of 2026, a subsequent regulatory submission, and continued development in additional distinct monotherapy indications including rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions. “We are pleased with the progress at Fore this year, which allowed us to expand our investor base with new, quality healthcare investors and are grateful for the continued support from all our existing investors, which reflects their confidence in the potential for plixorafenib to disrupt the BRAF market,” said William Hinshaw, Chief Executive Officer of Fore. “With target enrollment now complete in the primary CNS tumor basket, we look forward to reporting topline data from this basket around the end of 2026. With the recent Breakthrough Therapy Designation granted to plixorafenib, we continue to progress towards a planned regulatory submission in 2027 for BRAF V600E CNS tumors and bringing this novel mechanism and differentiated profile to patients who are in need of improved therapeutic options.” Plixorafenib Updates Fore Bio also announced several positive program updates for its ongoing FORTE study demonstrating continued timely execution as well as notable patient-friendly improvements to the protocol: Target enrollment of approximately 50 patients has been reached in the BRAF V600E CNS tumor basket of the FORTE study, and topline data from the study is now anticipated around the end of 2026. This basket previously met the pre-specified interim analysis, with the Independent Data Monitoring Committee (IDMC) supporting that the study may continue as planned based on responses assessed by blinded independent central review (BICR), in addition to the IDMC’s ongoing oversight for safety. The company anticipates that the primary analysis of data from this basket, if positive, would enable the submission of a New Drug Application to the U.S. Food and Drug Administration under the Accelerated Approval pathway. Based upon the protocol-specified decision rule and available safety and PK data, clearance from the IDMC has been received to enroll patients as young as 8 years of age, compared to a prior age range starting at 10 years old, to align more closely with the observed BRAF-altered patient population including children and young adults in which low-grade gliomas (LGG) and other primary CNS tumors more commonly occur. Fore Bio has implemented an improvement to the dosing regimen in the FORTE study to administer plixorafenib with food, on the basis of a recent food effect study. On the basis of this data, and the supportive data from clinical studies showing robust exposures and anti-tumor activity with plixorafenib alone, cobicistat, an approved CYP3A inhibitor designed to serve as a PK booster, will no longer be administered with plixorafenib. Mr. Hinshaw concluded, “With several key clinical and regulatory catalysts on the horizon, we believe plixorafenib has the potential to meaningfully improve upon the current treatment paradigm, representing a significant opportunity across several BRAF-altered CNS tumor types including high and low grade glial and glioneuronal brain and spinal cord tumors, glioblastomas, and others, in addition to the distinct patient populations currently being evaluated in the FORTE study.” The company is currently evaluating plixorafenib in two additional monotherapy baskets in the FORTE study, in rare BRAF V600 mutated solid tumors and advanced solid tumors with BRAF fusions, respectively. The company anticipates advancing through multiple clinical and regulatory milestones across the plixorafenib development program throughout 2026 and into 2027. About the Global Phase 2 FORTE Basket Study The registration-intended FORTE Master Protocol is 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 recurrent or progressive BRAF V600E primary CNS tumors, solid tumors with BRAF fusions and rare BRAF V600 mutated solid tumors. As part of the Bayesian adaptive design of the trial, interim efficacy analyses are conducted in each basket, for which the company reported a positive outcome from the BRAF V600 CNS basket in the third quarter of 2025. About Plixorafenib Plixorafenib is a novel BRAF inhibitor, with a unique mechanism of action that functions both as a dimer and paradox breaker, and that has demonstrated a differentiated and compelling monotherapy profile in clinical studies. Plixorafenib received Breakthrough Therapy Designation by the U.S. Food and Drug Administration in April 2026. In a previously conducted Phase 1/2 study in patients with MAPK inhibitor naïve BRAF V600 primary recurrent CNS tumors (n=9), plixorafenib monotherapy demonstrated an ORR of 67% and a clinical benefit rate of greater than 75%. In patients with V600 alterations who were MAPK inhibitor naïve, plixorafenib achieved a 42% response rate with prolonged duration of response (mDOR 17.8 months), with a clinical benefit rate of >70%. Plixorafenib also demonstrated a favorable safety and tolerability profile across tumor types, including relative to existing standard of care treatments for various BRAF altered tumors, with a discontinuation rate due to drug-related adverse events of less than 2%. Fore believes plixorafenib has the potential to overcome the limitations of currently available BRAF inhibitors through its unique mechanism of action targeting BRAF, while avoiding the limitations of the earlier generation BRAF inhibitors that led to rapid recurrence of disease and the need for combination with a MEK inhibitor. About FORE Biotherapeutics 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. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1st and 2nd generation BRAF inhibitors. For more information, please visit www.fore.bio or follow us on X and LinkedIn.

Phase 2Clinical ResultPhase 1Breakthrough Therapy

12 May 2026

·www.businesswire.com

FORE Biotherapeutics to Participate in Upcoming Investor Conferences

PHILADELPHIA--(BUSINESS WIRE)--FORE Biotherapeutics today announced that the Company will participate at the following investor conferences: Stifel 2026 Virtual Targeted Oncology Forum. The Company will attend on Tuesday, May 19, and will participate in a fireside chat at 12:30 p.m. ET. Jefferies 2026 Global Healthcare Conference. The Company will attend and participate in one-on-one meetings on Tuesday, June 2. Management will host and participate in one-on-one meetings. Please contact Argot Partners to schedule one-on-one meetings with the management team. About FORE Biotherapeutics 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. The Company’s lead asset plixorafenib (FORE8394; formerly PLX8394) is a V600 and non-V600 BRAF inhibitor rationally designed with a first-in-class mechanism to address treatment gaps from 1st and 2nd generation BRAF inhibitors. For more information, please visit www.fore.bio or follow us on X and LinkedIn.

100 Deals associated with Plixorafenib

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
BRAF mutation Solid Tumors	Phase 2	United States	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Australia	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Canada	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	France	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Germany	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Italy	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Netherlands	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Norway	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	South Korea	Fore Biotherapeutics, Inc.	21 Feb 2023
BRAF mutation Solid Tumors	Phase 2	Spain	Fore Biotherapeutics, Inc.	21 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05503797 (FORTE, AACR2026)	Phase 2	BRAF mutation Solid Tumors BRAF fusions \| BRAF V600-mutated	100	Plixorafenib (BRAF fusions + Advanced solid and primary CNS tumors)	tekacsfrmq(urbavxbmuk) = diivsflxfo bvackhyiet (etjycjztrv )	Positive	21 Apr 2026
NCT02428712 (Company_Website) Manual	Phase 1/2	Papillary thyroid cancer \| BRAF mutated anaplastic thyroid cancer BRAF Fusion \| BRAF V600E	21	plixorafenib ± cobicistat (BRAF-altered PTC (n=16) and ATC (n=5))	-	Positive	12 Sep 2025
NCT02428712 (Company_Website) Manual	Phase 1/2		21	plixorafenib ± cobicistat (BRAF V600-mutated PTC + MAPK‑inhibitor naïve)	oetndprvaa(rgrmvonabx) = qqjiwhwviu llppotlymn (ecsqywhrwe ) View more	Positive	12 Sep 2025
NCT02428712 (Phase 1/2a study, AACR2025)	Phase 1/2	BRAF mutation Solid Tumors BRAF alterations \| V600E \| class 2 SNVs ... View more	71	Plixorafenib	avlxdgyfox(nazsalipky) = emjlmcwjho pgvkqdiaxk (douuasvwvh )	-	28 Apr 2025
NCT02428712 (CTNI-76, SNO2023)	Phase 1/2	Central Nervous System Neoplasms BRAF-altered \| BRAFV600+	113	Plixorafenib 900-3600 mg/day	vqqpyeikdf(btktzazwzo) = dnnjlmufda ftbnwylhpi (irbhskioiy )	Positive	10 Nov 2023
NCT02428712 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	BRAF-mutation brain cancer \| HR-positive/HER2-low Solid Tumors BRAF	110	Plixorafenib±cobicistat	qkxqmfahew(qvymlstwus) = Dose-limiting toxicities were only observed at doses ≥1500 mg/day + cobi: 1500-1800 mg/day (4) and 2700-3600 mg/day (1). mfromhioft (awanrekxfk )	Positive	31 May 2023
NCT02428712 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2	HR-positive/HER2-low Solid Tumors \| Central Nervous System Neoplasms	110	FORE8394	zrouwojbax(lskswvspcc) = ayzodfjqlg dooihtbgfa (mdtrnaexqi ) View more	Positive	26 May 2023
NCT02428712 (ASCO 12023 \| ASCO 22023) Manual	Phase 1/2		110	FORE8394 (pts with MAPKi-naïve, V600 mutant tumors (excluding colorectal cancer [CRC]))	sctnrfqdyj(dzdqxywlik) = vfwarnciww lzwjcthtur (uhpvhmqzgt )	Positive	26 May 2023
NCT02428712 (ESMO2020)	Phase 1/2	Advanced cancer	69	PLX8394	bjtdlcyssc(hlamrdmroj) = 4 pts qxfqziwwur (aftoffrswv ) View more	Positive	18 Sep 2020
NCT02428712 (ASCO 12018 \| ASCO 22018) Manual	Phase 1/2	BRAF mutation Solid Tumors BRAF Mutation	31	PLX8394+cobicistat	bpzfcpbiuu(xeaahzbuet) = rcgzouzhbf mbrrohrtqa (pdeiohktow )	Positive	04 Jun 2018
NCT02428712 (ASCO 12018 \| ASCO 22018) Manual	Phase 1/2	BRAF mutation Solid Tumors BRAF Mutation	31	PLX8394+cobicistat	txtqnsbhrz(fclgilbabg) = kgfxhmqadi bveedzwhoz (vpvpzwzaej ) View more	Positive	04 Jun 2018

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