Drug intelligence / Profile preview

ITM-94

Development stage
Phase 2
Lead developer
ITM Isotope Technologies Munich
Modality
Antibody-Radionuclide Conjugates → Antibody Conjugates → Antibody-Based Therapeutics, Peptides
Administration
Intravenous
01

Overview

ITM-94 is a Gallium-68 (⁶⁸Ga)-labeled PET imaging radiopharmaceutical agent designed to identify patients whose cancers overexpress Carbonic Anhydrase IX (CAIX). It is part of a theranostic pair with ITM-91, where ITM-94 serves as the diagnostic component to detect CAIX-expressing tumors, particularly clear cell renal cell carcinoma (ccRCC). The imaging agent has demonstrated exceptional tumor imaging characteristics with high tumor-to-background ratios and favorable tolerability profiles. ITM-94 may be used independently as a diagnostic tool and is designed to help guide treatment decisions by identifying patients suitable for targeted radiopharmaceutical therapy. Originally discovered by 3B Pharmaceuticals and licensed to Debiopharm, ITM secured exclusive global development and commercial rights in September 2024. The agent is being evaluated in a five-part Phase 1/2 clinical trial for its effectiveness in detecting CAIX-expressing solid tumors, with particular focus on distinguishing ccRCC from non-cancerous renal masses.

Other names
ITM-94DITM94DITM 94DDebio 0328Debio0328Debio-0328
02

Targets

CA9 (Carbonic anhydrase IX)

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