ITM Isotope Technologies Munich SE announced that the U.S. Food and Drug Administration has granted Fast Track designation to ITM-94 ([68Ga]Ga-DPI-4452) as a diagnostic agent for detecting clear cell renal cell carcinoma (ccRCC). The designation was granted based on ITM-94's potential as a more effective, non-invasive diagnostic agent designed to improve outcomes for people living with ccRCC, a condition with high unmet medical need.
"The FDA's Fast Track designation is a validation of ITM-94's potential to aid in the non-invasive diagnosis of renal cell carcinoma," said Dr. Celine Wilke, chief medical officer of ITM. "We have seen promising data in our ongoing clinical trial that suggest ITM-94 could change how clinicians diagnose and stage patients across the broader ccRCC disease landscape, with potential utility in supporting clinical decision-making for indeterminate renal masses as well."
Novel Theranostic Approach
ITM-94 is a gallium-68-radiolabeled PET imaging agent that, together with radiotherapeutic compound ITM-91 ([177Lu]Lu-DPI-4452), comprises a first-in-class, peptide-based theranostic pair. The theranostic pair targets carbonic anhydrase IX (CAIX), a cell surface protein that plays a key role in the tumor microenvironment, promoting tumor growth, survival, invasion and metastasis.
ITM-94 is currently being evaluated in Part D of the ongoing Phase 1/2 clinical trial for its effectiveness to accurately detect ccRCC in patients with indeterminate renal masses (IDRM) when compared to CT/MRI imaging, with histopathological confirmation of diagnosis. Secondary endpoints include assessments of the imaging agent's sensitivity, specificity and Positive Predictive Value (PPV) and Negative Predictive Value (NPV) compared to histology.
Clinical Trial Progress
The multi-part clinical trial (NCT05706129) is designed to assess the safety and tolerability, imaging characteristics, and efficacy of the theranostic pair ITM-91/ITM-94 in patients with unresectable, locally advanced or metastatic solid tumors. In the first-in-human part of the trial (Part A), ITM-94 has demonstrated exceptional tumor imaging characteristics, with a high tumor-to-background ratio and a favorable tolerability profile in patients with confirmed ccRCC.
Part B is currently assessing increasing doses of the therapeutic agent, ITM-91, in ccRCC patients whose tumors show CAIX expression as evidenced by uptake of the imaging tracer, ITM-94. Based on the recommended dose and treatment schedule obtained from Part B, expansion Part C of the trial will evaluate the safety and preliminary efficacy of ITM-91 in patients with ccRCC, and potentially other CAIX-expressing tumor types. Part D is evaluating the effectiveness of ITM-94 in classifying indeterminate renal masses, such as ccRCC.
Regulatory Advantages
FDA Fast Track designation is designed to facilitate the development and expedite the review of new diagnostics and therapies that are intended to treat serious or life-threatening conditions and have the potential to address an unmet medical need. Programs granted this designation are eligible for more frequent communications with the FDA during clinical development and for accelerated approval and/or priority review over standard reviews if relevant criteria are met.
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. The company advances a broad precision oncology pipeline, including multiple phase 3 studies, combining high-quality radioisotopes with a range of targeting molecules.
