Fusion Pharmaceuticals receives IND clearance for Alpha therapy FPI-2068

Fusion Pharmaceuticals (FUSN) announced the clearance of investigational new drug – IND – applications for FPI-2068 and corresponding imaging analogue FPI-2107 to the FDA. Fusion is jointly developing FPI-2068 with AstraZeneca (AZN) under the companies’ multi-asset collaboration agreement. FPI-2068 is a targeted alpha therapy – TAT – designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening in order to better predict the cadence of patient enrollment. FPI-2068 will be the first program to enter clinical development under the company’s collaboration agreement with AstraZeneca, which includes joint discovery, development and the option to co-commercialize novel TATs leveraging Fusion’s proprietary Fast-Clear linker technology platform with antibodies from AstraZeneca’s oncology portfolio, as well as exploration of potential combination strategies involving existing assets in their respective portfolios. Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.