[64Cu]Cu-AKY-2519

[64Cu]Cu-AKY-2519 is an investigational diagnostic radiopharmaceutical developed by Aktis Oncology for the imaging of solid tumors, specifically those expressing B7-H3 (CD276), such as prostate and lung cancers. The agent is a miniprotein radioconjugate consisting of a high-affinity miniprotein binder specific to B7-H3, labeled with the radioactive isotope copper-64 (64Cu). It is designed for use with PET/CT imaging to visualize tumor lesions and evaluate the biodistribution of the targeting moiety. [64Cu]Cu-AKY-2519 serves as a companion diagnostic for the therapeutic alpha-radiopharmaceutical [225Ac]Ac-AKY-2519, enabling patient selection and dosimetry before treatment. In March 2026, the FDA cleared the IND for a Phase 1b clinical trial of this agent.

Other names

[64Cu]-AKY-251964Cu-AKY-2519Copper-64 AKY-2519Copper64 AKY-2519Copper 64 AKY-2519