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Drug intelligence / Profile preview
Ga-DPI-4452 (also known as ITM-94 or Debio 0328) is a first-in-class, gallium-68-radiolabeled cyclic peptide (peptidomimetic) that acts as a diagnostic positron emission tomography (PET) imaging agent. It targets Carbonic Anhydrase IX (CAIX), a cell-surface glycoprotein that is highly overexpressed in hypoxic tumors and clear cell renal cell carcinoma (ccRCC) but has restricted expression in healthy tissues. Ga-DPI-4452 forms a theranostic pair with its therapeutic counterpart, [177Lu]Lu-DPI-4452 (ITM-91), which is radiolabeled with lutetium-177 for targeted radionuclide therapy. Originally discovered by 3B Pharmaceuticals, the theranostic pair was licensed to Debiopharm and subsequently exclusively licensed to ITM Isotope Technologies Munich in September 2024. Ga-DPI-4452 is currently in Phase 1/2 clinical development for the detection and staging of ccRCC, indeterminate renal masses, and other CAIX-expressing solid tumors, including colorectal cancer and pancreatic ductal adenocarcinoma.
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