FORE Biotherapeutics has completed target enrolment in the primary central nervous system (CNS) tumour cohort of its registrational Phase 2 FORTE study evaluating plixorafenib for BRAF V600E-positive cancers.

The company also announced a $67.4 million extension to its Series D-2 financing, which will support late-stage clinical development of plixorafenib, regulatory activities and additional clinical programmes.

FORE said approximately 50 patients have now been enrolled in the BRAF V600E primary CNS tumour basket of the FORTE study, with topline data expected around the end of 2026. If successful, the company plans to submit a New Drug Application to the FDA through the Accelerated Approval pathway during 2027.

The milestone follows the recent award of FDA Breakthrough Therapy Designation for plixorafenib in BRAF V600E primary CNS tumours.

Alongside completion of enrolment, the company announced several protocol updates designed to improve the patient experience during the study.

Following review by the Independent Data Monitoring Committee, the minimum enrolment age has been lowered from 10 years to eight years to better reflect the patient population affected by low-grade gliomas and other primary CNS tumours.

FORE has also updated the dosing regimen following food-effect studies. Patients will now take plixorafenib with food, while cobicistat, previously used to boost drug exposure, has been removed from the treatment regimen.

The company said these changes were supported by pharmacokinetic and clinical data demonstrating robust drug exposure and anti-tumour activity with plixorafenib alone.

William Hinshaw, chief executive officer of FORE Biotherapeutics, said: “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.”

He added: “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.”

The FORTE study is a global, registration-intended Phase 2 basket trial evaluating plixorafenib across several tumour types driven by BRAF alterations. In addition to recurrent or progressive primary CNS tumours, the study is investigating rare BRAF V600-mutated solid tumours and advanced solid tumours containing BRAF fusions.

Plixorafenib is a next-generation BRAF inhibitor designed to overcome limitations associated with earlier therapies by targeting both V600 and non-V600 BRAF alterations.

The latest financing brings FORE’s total Series D-2 funding to $110 million and will support continued development of plixorafenib through multiple anticipated clinical and regulatory milestones over the next two years.