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Cu-AKY-2519 (also known as [64Cu]Cu-AKY-2519) is a clinical-stage miniprotein radioconjugate targeting B7-H3 (CD276), developed by Aktis Oncology. It is designed as a diagnostic imaging agent utilizing the positron-emitting radioisotope copper-64 (64Cu) for PET imaging and dosimetry, forming a theranostic pair with the therapeutic actinium-225-labeled counterpart, [225Ac]Ac-AKY-2519. The miniprotein scaffold of AKY-2519 is engineered for high tumor penetration, rapid internalization, and prolonged retention in B7-H3-expressing cancer cells, coupled with rapid renal clearance to minimize normal tissue exposure. Cu-AKY-2519 is currently being evaluated in Phase 1b clinical trials for the imaging and dosimetry of patients with B7-H3-expressing solid tumors, including metastatic castration-resistant prostate cancer (mCRPC) and non-small cell lung cancer (NSCLC).
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