Radiopharm Theranostics received US Food and Drug Administration Investigational New Drug Application approval for its V6 Integrin (RAD301) technology. The approval allows Radiopharm to begin a Phase 1 imaging trial in ambulatory patients with pancreatic cancer, targeting commencement at the end of First Quarter CY23 with an estimated close by Third Quarter CY23. Radiopharm is now proceeding with clinical site preparation for the trial, with the first subject expected to be dosed at Montefiore Einstein Cancer Center (MECC) in New York.

Pancreatic cancer presents a high unmet medical need with current imaging options having several limitations. RAD301 technology has already generated significant clinical data from 88 patients dosed to date in various geographies. Radiopharm Theranostics and TRIMT GmbH entered into an exclusive license agreement in August 2021 to develop radiopharmaceuticals including Ga68-Integrin (RAD301).