U.S. FDA Grants Fast Track Designation to ITM’s ITM-94, a Diagnostic Agent for Clear Cell Renal Cell Carcinoma

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  • ITM-94, along with ITM-91, is designed to target carbonic anhydrase IX (CAIX) in clear cell renal cell carcinoma as a theranostic pair

Garching / Munich, Germany, November 17, 2025 – ITM, a prominent radiopharmaceutical biotech company, announced today that the FDA has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) for use as a diagnostic agent in detecting clear cell renal cell carcinoma (ccRCC). The designation was awarded based on ITM-94’s potential to be a more effective, non-invasive diagnostic tool that could improve outcomes for individuals with ccRCC, a condition with significant unmet medical needs1.

“The FDA’s Fast Track designation acknowledges ITM-94’s potential to assist in the non-invasive diagnosis of renal cell carcinoma,” said Dr. Celine Wilke, chief medical officer of ITM. “Our ongoing clinical trial has yielded promising data suggesting that ITM-94 could transform how clinicians diagnose and stage patients across the ccRCC spectrum, potentially aiding in clinical decisions for uncertain renal masses. This announcement underscores the innovation within our pipeline and the crucial role of an effective diagnostic in cancer treatment.”

ITM-94 is a gallium-68-labeled PET imaging agent that, together with the radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), constitutes a first-in-class, peptide-based theranostic pair. This pair targets carbonic anhydrase IX (CAIX), a cell surface protein important in the tumor microenvironment, which promotes tumor growth, survival, invasion, and metastasis. ITM-94 is currently being assessed in Part D of a Phase 1/2 clinical trial to determine its effectiveness in accurately detecting ccRCC in patients with indeterminate renal masses (IDRM) compared to CT/MRI imaging, confirmed by histopathological diagnosis. Secondary endpoints include evaluating the imaging agent’s sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) against histology.

The FDA’s Fast Track designation aims to accelerate the development and review of new diagnostics and treatments for serious or life-threatening conditions that address unmet medical needs. Programs with this designation benefit from more frequent communication with the FDA during clinical development and may qualify for accelerated approval and/or priority review if the criteria are met.

About the Phase 1/2 ITM-91/ITM-94 Trial
This multi-part clinical trial is designed to evaluate the safety, tolerability, imaging characteristics, and efficacy of the ITM-91/ITM-94 theranostic pair in patients with unresectable, locally advanced, or metastatic solid tumors. In the first-in-human part of the trial (Part A), ITM-94 showed excellent tumor imaging characteristics, with a high tumor-to-background ratio and good tolerability in patients with confirmed ccRCC1. Part B is currently evaluating increasing doses of the therapeutic agent, ITM-91, in ccRCC patients whose tumors express CAIX, as shown by ITM-94 uptake. Based on the dose and treatment schedule from Part B, Part C will assess the safety and preliminary efficacy of ITM-91 in ccRCC patients and potentially other CAIX-expressing tumor types. Part D is assessing ITM-94’s effectiveness in classifying indeterminate renal masses, including ccRCC.

About ITM Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is focused on developing innovative radiopharmaceutical therapeutics and diagnostics for challenging tumors. We strive to meet the needs of cancer patients, clinicians, and partners through excellence in the development, production, and global supply of medical radioisotopes. Driven by the goal of improving patient outcomes, ITM is advancing a broad precision oncology pipeline, with multiple phase 3 studies, combining high-quality radioisotopes with various targeting molecules. Leveraging two decades of radiopharma expertise, a central industry position, and an established global network, ITM aims to provide patients with more effective targeted treatments to improve clinical outcomes and quality of life.

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1 Hofman, M. S., B. Tran, D. R. Feldman, A. Pokorska-Bocci, S. Pichereau, J. Wessen, M. B. Haskali, R. B. Sparks, O. Vlasyuk, and I. Galetic. 2024. ‘First-in-Human Safety, Imaging, and Dosimetry of a Carbonic Anhydrase IX-Targeting Peptide, [(68)Ga]Ga-DPI-4452, in Patients with Clear Cell Renal Cell Carcinoma’, J Nucl Med, 65: 740-3.

 

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