Radiopharm Theranostics (ASX: RAD) has announced that the US FDA has granted clearance of its Investigational New Drug (IND) application for Betabart (RV-01), its Lu177-B7H3 monoclonal antibody.
B7-H3 is an immune checkpoint molecule that is overexpressed across several tumour types and has emerged as a target for antibody-based cancer immunotherapy. Deregulated B7-H3 expression is consistently correlated with enhanced tumour aggressiveness and poor clinical outcomes. Targeting the 4 Ig isoform of B7-H3 with a selective radioligand therapy may offer a novel strategy for treating refractory or high-risk tumours.
“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, Radiopharm 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 tumours. We are excited to advance this program into the clinic and anticipate dosing the first patients later this year.”
“Recent reported preclinical studies demonstrated that RV-01 exhibits hepatic clearance, allowing the isotope sufficient time to effectively target tumours while potentially minimising adverse effects such as haematological toxicities. Unlike peptides or small molecules, monoclonal antibodies are primarily cleared by the liver—an organ known for its radio-resistance. This characteristic, combined with the shortened half-life of RV-01 and the strong affinity for the target make this agent stand out and may offer a significant advantage not just over other monoclonal antibodies but also targeted radiotherapeutics with renal excretion pathway, the latter of which are often associated with higher risk of radiopharmaceutical-induced kidney toxicity,” said Dr Dimitris Voliotis, Radiopharm's Chief Medical Officer.