Radiopharm receives IND approval from US FDA to initiate study of RV-01

Radiopharm (RADX) Theranostics announced that the U.S. Food and Drug Administration, FDA, has provided clearance of the Company’s Investigational New Drug, IND, application for Betabart, its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7H3 that is highly expressed in tumors and not in healthy tissues. “FDA clearance to initiate our first-in-human Phase 1 clinical trial of RV-01 represents a major milestone for Radiopharm Theranostics and our joint venture with MD Anderson Cancer Center,” said Riccardo Canevari, CEO and Managing Director. “RV-01 is the first monoclonal antibody developed through this collaboration, and we believe it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumors. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.”