Fusion Pharma receives clearance from FDA to begin tumor treatment trial
- Fusion Pharma (NASDAQ:FUSN) said it had received clearance for its investigational new drug (IND) applications for FPI-2068 and corresponding imaging analogue FPI-2107 to the U.S. Food and Drug Administration (FDA).
- Fusion is jointly developing FPI-2068, a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET, with AstraZeneca (AZN) under the companies' multi-asset collaboration agreement.
- 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.
- EGFR and cMET are both 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.