Fusion Pharmaceuticals and AstraZeneca’s FPI-2068 shows anti-tumor efficacy

Fusion Pharmaceuticals (FUSN) announced the presentation of preclinical data for FPI-2068, a clinical stage bispecific IgG-based targeted alpha therapy designed to deliver actinium-225 to various solid tumors that co-express EGFR-cMET. Fusion is jointly developing FPI-2068 with AstraZeneca (AZN) under the companies’ multi-asset collaboration agreement. In the preclinical study, FPI-2068 demonstrated anti-tumor efficacy in colorectal and lung tumor xenograft mouse models, and single dose administration of FPI-2068 led to prolonged tumor regression. Further, FPI-2068 caused activation of the DNA damage response pathway as well as apoptosis, suggesting an inability of the cellular machinery to repair the DNA damage induced by the alpha radiation, consistent with the proposed primary mechanism of action. These data provide further evidence supporting the clinical development of FPI-2068, which is expected to enter a Phase 1 study for the treatment of solid tumors co-expressing EGFR-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.