Fusion Pharmaceuticals provides clinical and manufacturing updates

Fusion Pharmaceuticals announced progress with its FPI-2265 development program, an update on FPI-1434 Phase 1 Cohort 2 data and the production of the first clinical doses at the company’s proprietary manufacturing facility. The company has aligned with the FDA on its submitted Phase 2/3 protocol for FPI-2265, a targeted alpha therapy targeting prostate specific membrane antigen for the treatment of patients with metastatic castration-resistant prostate cancer with progressive disease. The updated development plan includes a Phase 2 dose optimization lead-in, expected to complete enrollment by the end of 2024, and a Phase 3 registrational trial expected to begin in 2025. The Phase 2 trial is expected to initiate in Q2 with enrollment completed by year-end. The company will seek to hold an End of Phase 2 meeting with the FDA to determine the recommended Phase 3 dosing regimen based on analysis of the Phase 2 data. The company plans to initiate the Phase 3 trial in 2025. The company is also pursuing the opportunity to potentially move the therapy candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year. Fusion announced encouraging early findings from Cohort 2 in the ongoing FPI-1434 Phase 1 clinical trial. No dose limiting toxicities were observed to date in the 25 kBq/kg dose cohort. FPI-1434 was well tolerated, with no DLTs and transient Grade 1 or less thrombocytopenia at the 25 kBq/kg dose level. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024. Fusion has completed validation of its good manufacturing practice manufacturing facility and produced the first clinical dose of a TAT. Fusion’s facility is expected to be capable of producing up to 100,000 doses per year. As of September 30, 2023, Fusion’s cash, cash equivalents and investments were approximately $287M. Fusion expects its cash, cash equivalents and investments will now be sufficient to fund operating expenses and capital expenditure requirements into Q4 2025.