Radiopharm Theranostics has received FDA Investigational New Drug (IND) application clearance for Betabart (RV-01), a Lu177-B7H3 monoclonal antibody targeting the 4Ig isoform of B7-H3, prevalent in solid tumors. This marks the first human trial for a drug developed through Radiopharm’s joint venture with MD Anderson Cancer Center, aiming to address unmet needs in oncology. The trial is expected to begin in the fourth quarter of 2025.
This IND clearance is a crucial step forward in the fight against aggressive solid tumors. RV-01’s unique targeting of the 4Ig B7-H3 isoform, coupled with its liver-based clearance, offers the potential for improved efficacy and reduced kidney toxicity, a common side effect of other radiopharmaceuticals. This targeted approach may lead to better outcomes for patients with refractory or high-risk tumors where current therapies are inadequate.
RV-01 is a first-in-class targeted radiopharmaceutical. Preclinical data suggest it exhibits hepatic clearance, allowing sufficient time for tumor targeting while potentially minimizing hematological toxicities. This mechanism differs from other targeted radiotherapeutics often associated with kidney toxicity. Furthermore, RV-01’s high affinity for the 4Ig B7-H3 isoform helps it bypass the soluble 2Ig isoform in the bloodstream, enhancing tumor targeting and avoiding immune complex formation.
This FDA clearance sets the stage for crucial clinical data on RV-01’s safety and efficacy. Positive results from the upcoming Phase 1 trial could validate the drug’s novel mechanism of action and its potential as a new treatment option for various solid tumors, potentially leading to further clinical development and eventual commercialization. This represents a significant advancement in targeted radiopharmaceutical therapy and offers renewed hope for patients with aggressive solid tumors.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
