ITM Secures Global License from Debiopharm for CA IX-Targeted Radiopharmaceuticals for Solid Tumors

MUNICH & GARCHING, Germany & LAUSANNE, Switzerland I September 12, 2024 I ITM Isotope Technologies Munich SE (ITM), a prominent radiopharmaceutical biotech company, and Debiopharm, a Swiss-based global biopharmaceutical firm, announced a pivotal agreement. ITM has secured an exclusive global license for the clinical and commercial advancement of the peptide-based theranostic pair ITM-91/ITM-94D, formerly known as Debio 0228/0328. This pair targets the Carbonic Anhydrase IX (CA IX) surface protein, which is significant in the tumor microenvironment, aiding in tumor growth, survival, invasion, and metastasis.

ITM-91 (Debio 0228) is a Lutetium-177-labeled radioligand therapeutic compound, while ITM-94D (Debio 0328) is a Gallium-68-labeled imaging agent. These compounds are currently under investigation in the phase 1/2 GaLuCi™ clinical trial, focusing on patients with locally advanced ccRCC, PDAC, and CRC. Although further financial details weren't disclosed, this acquisition enhances ITM's radiopharmaceutical pipeline, demonstrating its commitment to developing innovative diagnostic and therapeutic solutions for global patient care.

Dr. Andrew Cavey, CEO of ITM, emphasized that acquiring this clinical-stage theranostic pairing aligns with ITM's mission to expand access to advanced radiopharmaceuticals worldwide. He expressed optimism about the potential for CA IX-targeted radiopharmaceutical therapies and the progress of the GaLuCi™ trial. Bertrand Ducrey, CEO of Debiopharm, echoed this sentiment, highlighting the promising trial data for their imaging radiotracer, which has shown high-quality images with significant tumor uptake and excellent tumor-to-background ratios. This has bolstered their confidence in the forthcoming evaluation of the therapeutic agent, Debio 0228.

Debiopharm's expertise in drug development, particularly in radioligand therapies, has enabled them to bridge innovative discoveries with leading pharmaceutical companies for commercialization. As a global leader in manufacturing n.c.a. Lutetium-177, ITM will leverage its production capabilities and clinical expertise to advance the development of this theranostic pair.

Prof. Michael Hofman from the Peter MacCallum Cancer Center in Melbourne, an investigator in the GaLuCi™ study, expressed hope that trials like GaLuCi™ would improve treatment options for patients with advanced renal cancer, particularly those with limited treatment alternatives following immune-oncology or tyrosine kinase inhibitor therapy. Darren R. Feldman, MD, from the Memorial Sloan Kettering Cancer Center, another investigator in the study, highlighted the potential of theranostic approaches to target specific surface proteins, offering improved outcomes for patients with hard-to-treat malignancies such as kidney cancer.

ITM-91/ITM-94D (Debio 0228/0328) is an investigational theranostic pair initially discovered by 3B Pharmaceuticals GmbH and now licensed to ITM. ITM-94D (Debio 0328) is a PET imaging agent designed to identify cancers overexpressing CA IX, while ITM-91 (Debio 0228) aims to deliver targeted radiation to destroy tumors from within.

The GaLuCi™ trial, a first-in-human, multicenter, non-randomized phase 1/2 clinical trial, is assessing the safety, tolerability, imaging characteristics, and efficacy of the ITM-91/ITM-94D pair in patients with unresectable, locally advanced, or metastatic solid tumors. The trial is conducted in three stages. Part A evaluates the imaging agent's safety and performance in detecting CA IX-expressing tumors. Part B will assess escalating doses of ITM-91 in patients with high tracer uptake. Finally, Part C will further evaluate the safety and preliminary efficacy of ITM-91 in ccRCC, PDAC, and CRC based on Part B's recommended dose.

ITM Isotope Technologies Munich SE is a leader in radiopharmaceutical biotechnology, dedicated to providing precision therapeutics and diagnostics for challenging tumors. With a strong focus on patient benefit, ITM advances a comprehensive precision oncology pipeline and aims to improve clinical outcomes and quality of life for patients globally.

Debiopharm is committed to developing innovative therapies targeting high unmet medical needs in oncology and bacterial infections, bridging the gap between discovery and patient access. The company identifies high-potential compounds, demonstrates their safety and efficacy, and partners with large pharmaceutical companies to maximize patient access worldwide.