Radiopharm Theranostics (ASX: RAD), a company focused on developing radiopharmaceutical products for both diagnostic and therapeutic uses, has secured investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) for its therapeutic candidate, Betabart (RV-01). RV-01 targets the B7H3 immune checkpoint molecule, which plays a significant role in cancer development and progression. The FDA clearance paves the way for Radiopharm to initiate a first-in-human Phase 1 clinical trial of RV-01, developed in collaboration with the MD Anderson Cancer Centre at the University of Texas.
Radiopharm’s managing director, Riccardo Canevari, expressed optimism about RV-01, citing promising results from animal studies that demonstrated tumour shrinkage and prolonged survival. Canevari highlighted that RV-01 is the first monoclonal antibody developed through their collaboration with MD Anderson Cancer Centre and believes it has the potential to become a highly differentiated radiopharmaceutical for patients with aggressive solid tumours. The company believes RV-01’s characteristics, including liver clearance and strong affinity for BH73, may offer an advantage over other targeted radiotherapeutics.
In other company news, Radiopharm appointed Dr Oliver Sartor, a medical oncologist specialising in prostate cancer and radiopharmaceutical therapies, to its scientific advisory board. Dr Sartor’s extensive experience, including authoring over 500 peer-reviewed publications and leading multiple Phase 3 trials, is expected to provide valuable insights as Radiopharm advances its therapeutic pipeline. Furthermore, Radiopharm received a research and development (R&D) tax refund of $4.48 million, including interest, which will be used for the continued development of its radiopharmaceutical portfolio.
