- New study arm (Part D) is part of the broad clinical development plan of the ITM-91/ITM-94 theranostic program in patients with Carbonic Anhydrase IX (CAIX)-expressing tumors
- Part D builds on promising imaging data demonstrated in Part A of the study for ITM-94, a Gallium-68 (68Ga)-labeled PET imaging candidate, as a diagnostic agent for early-stage clear cell renal cell carcinoma (ccRCC)
- Together with ITM-91, a Lutetium-177 (177Lu)-labeled radiotherapeutic candidate, ITM-94 is a theranostic pair, which ITM licensed exclusively from Debiopharm for clinical and commercial development in September 2024
Garching / Munich, Germany, and Lausanne, Switzerland - June 23, 2025 - ITM Isotope Technologies Munich SE, a leading radiopharmaceutical biotech company and Debiopharm, a Swiss-based, global biopharmaceutical company aiming to establish tomorrow's standard-of-care to cure cancer and infectious diseases, today announced that the first patient was imaged in a new study arm of a five-part, Phase 1/2 clinical trialevaluating the theranostic pair ITM-94/ITM-91 for identification and treatment of patients who have unresectable, locally advanced or metastatic solid tumors. As a new component of a broad clinical development plan for ITM-91/ITM-94, Part D of the trial will evaluate the effectiveness of ITM-94 in classifying indeterminate renal mass as either ccRCC or non-cancerous.
ITM-91/ITM-94 is a first-in-class, peptide-based theranostic pair combining the radiotherapeutic compound ITM-91, ITM gained the exclusive worldwide license from Debiopharm for the development and commercial rights of ITM-91/ITM-94. The initiation of this study arm represents a significant advancement for ITM and Debiopharm following their licensing agreement.
In the now initiated Part D of the trial, ITM-94 is being evaluated for its effectiveness to accurately classify an indeterminate renal mass as ccRCC or non-cancerous, when compared to CT/MRI imaging and histopathology. Secondary endpoints include sensitivity, specificity, and the positive and predictive value of ITM-94 PET/CT imaging compared to histopathology. This study arm is expected to enroll approximately 36 patients at around 15 clinical sites across the EU, US and Australia.
"The early results from the Gallium-68 CAIX PET/CT diagnostic are remarkable to date. I believe ITM-94 has the potential to change the way urologists and oncologists diagnose and stage patients with clear cell renal cell carcinoma, improving accuracy and reducing the need for biopsies. I have not seen a tracer with a similar profile since the PSMA PET/CT was established," added Prof. Michael Hofman, Director, Prostate Cancer Theranostics and Imaging Centre of Excellence (ProSTIC), Peter MacCallum Cancer Centre, Melbourne, Australia.
"Clear cell renal cell carcinoma is the most common form of kidney cancer, with more than 90% of cases overexpressing the CAIX encoding gene. As survival rates are highly dependent on the stage of progression, rapid and precise diagnosis is essential to provide patients with the best possible treatment options and therapeutic outcomes. ITM-94 has already demonstrated potential exceptional imaging qualities, including high tumor-to-background ratios and detecting lesions not visible by CT scan with a potential favorable safety profile. We look forward to exploring the full potential of the theranostic pair ITM-91/ITM-94 across this trial to characterize and treat CAIX expressing cancer cells, advancing the efficacy of targeted radiopharmaceutical therapies," said Dr. Celine Wilke, Chief Medical Officer of ITM.
"With high-quality imaging and high tumor uptake, ITM-94 has already demonstrated potentially significant diagnostic capabilities in solid tumors. The data gathered in Part D of the trial will be instrumental to the further validation of this theranostic pair. We highly value our partnership with ITM, which will continue to advance the rapid progression of these novel radio-diagnostics and -therapeutics through the clinic," said Angela Zubel, Chief Development Officer, Research & DevelopmentatDebiopharm.
About the Phase 1/2 ITM-91/ITM-94 Trial
The five-part clinical trial. Part B, which is ongoing, is assessing escalating doses of the therapeutic agent, ITM-91, in patients whose tumors show high uptake of the imaging tracer. Based on the recommended dose from Part B, Part C of the trial will assess the safety and preliminary efficacy of ITM-91 in patients with ccRCC, pancreatic ductal adenocarcinoma, colorectal cancer, urothelial carcinoma and potentially other tumor types. In addition to the newly initiated Part D, Part E will assess ITM-94 uptake in other tumors. ITM will assume full sponsorship of the program from Debiopharm once the transfer is completed.
About ITM-91/ITM-94
Debiopharm's commitment to patients
Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit www.debiopharm.com.We are on X. Follow us @DebiopharmNews at http://twitter.com/DebiopharmNewsor on LinkedIn.
ITM Contact
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Email: communications@itm-radiopharma.com
Investor Relations
Ben Orzelek
Phone: +49 89 329 8986 1009
Email: investors@itm-radiopharma.com
Debiopharm Contact
Dawn Bonine - Head of Communications
dawn.bonine@debiopharm.com
Tel: +41 (0)21 321 01 11
Attachment
- 20250623_ITM and Debiopharm Announce First Patient Imaged in New Study Arm Evaluating ITM-94 as Diagnostic Agent for Clear Cell Renal Cell Carcinoma (https://ml-eu.globenewswire.com/Resource/Download/7903ee36-1b10-4a15-926b-af53774131b9)
