Fusion Pharma Begins Phase 2 Dosing in AlphaBreak Trial for Metastatic Castration-Resistant Prostate Cancer

Fusion Pharmaceuticals Inc., a clinical-stage oncology company, has announced the dosing of the first patient in the Phase 2 segment of the AlphaBreak trial. This study investigates FPI-2265, an actinium-225 based PSMA targeting radioconjugate (RC), in individuals with metastatic castration-resistant prostate cancer (mCRPC).

The AlphaBreak trial is a Phase 2/3, randomized, open-label, multicenter study designed to evaluate the safety and efficacy of FPI-2265 in patients who have previously undergone 177Lu-PSMA radiotherapy. The Phase 2 portion aims to determine if there are additional safety and efficacy benefits from two alternative dosing regimens compared to the previously studied dose of 100 kBq/kg every eight weeks. The goal is to enroll around 60 patients by the end of 2024. Upon completion and analysis of the Phase 2 data, a Phase 3 global registration trial will commence, enrolling approximately 550 patients in 2025.

Dr. Dmitri Bobilev, the Chief Medical Officer at Fusion, highlighted the promise of actinium-based PSMA targeting RCs, underscoring positive safety and clinical activity data from the Phase 2 TATCIST trial presented at the AACR Annual Meeting. Dr. Luke Nordquist, an investigator in the study, emphasized the urgent need for new treatment options for mCRPC patients, particularly those who have progressed after lutetium-based radiotherapy. He noted that FPI-2265's promising clinical activity and safety profile could fill this gap.

FPI-2265 operates by harnessing the abilities of actinium-225, an alpha particle-emitting isotope. Due to its potential for delivering high radiation doses over short distances, actinium-225 targets cancer cells more effectively, reducing harm to surrounding healthy tissue.

Fusion Pharmaceuticals, the company behind this innovative treatment, focuses on developing next-generation RCs. Their approach involves conjugating alpha-emitting isotopes to various targeting molecules to deliver these payloads directly to tumors. Fusion's developmental pipeline includes FPI-2265 and other novel RCs aimed at treating solid tumors. The company has established a state-of-the-art, GMP-compliant radiopharmaceutical manufacturing facility to meet the supply demands of their growing RC pipeline. Additionally, Fusion has strategic actinium supply agreements with Niowave, Inc. and BWXT Medical.

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