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[68Ga]Ga-AKY-2519 is a gallium-68-labeled diagnostic radiopharmaceutical developed by Aktis Oncology. It consists of a novel miniprotein binder that specifically targets B7-H3 (CD276), a cell-surface antigen frequently overexpressed in various solid tumors, including metastatic castration-resistant prostate cancer (mCRPC). As a PET/CT imaging agent, it is used to evaluate biodistribution and tumor uptake, serving as a companion diagnostic surrogate for therapeutic radioconjugates targeting the same antigen, such as [177Lu]Lu-AKY-2519 and [225Ac]Ac-AKY-2519. Early clinical data from first-in-human studies demonstrate robust tumor uptake across multiple metastatic sites with favorable dosimetry and safety profiles.
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