Betabart (RV-01) has received Investigational New Drug (IND) clearance from the FDA, enabling the initiation of a first-in-human Phase 1 clinical trial, expected to begin in the fourth quarter of 2025.

RV-01 is a pioneering radiopharmaceutical monoclonal antibody targeting the B7H3 immune checkpoint molecule, a protein notably overexpressed in multiple aggressive solid tumors but minimally present in healthy tissues. The molecule’s overexpression has been linked to increased tumor aggressiveness and poor clinical outcomes, making B7H3 a compelling target for innovative cancer treatments. RV-01 is conjugated with the radioactive isotope Lutetium-177, designed to deliver targeted radiation therapy directly to cancer cells, aiming to maximize tumor destruction while sparing healthy tissues.

Preclinical studies have demonstrated promising results, including tumor shrinkage and prolonged survival in animal models, underscoring its potential efficacy against solid tumors.

One unique aspect of RV-01 is its clearance pathway through the liver, which is more radio-resistant compared to the kidneys, common clearance organs for similar therapies. This hepatic clearance may reduce side effects such as kidney toxicity, which is frequently associated with radiopharmaceuticals eliminated renally.

Importantly, RV-01’s targeting of B7H3 is highly relevant to prostate cancer treatment. B7H3 is overexpressed in prostate tumors, particularly in aggressive and treatment-resistant forms such as castration-resistant prostate cancer.

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