ITM and Radiopharm Ink Lutetium-177 Supply Deal

GARCHING / MUNICH, Germany and SYDNEY, May 19, 2025 – ITM Isotope Technologies Munich SE (ITM), a prominent biotech company in the field of radiopharmaceuticals, has finalized a supply agreement with Radiopharm Theranostics. Radiopharm, recognized for its pioneering platform of radiopharmaceutical products, will now have access to ITM’s non-carrier-added Lutetium-177 (n.c.a. 177Lu). This radioisotope is fundamental to Radiopharm’s clinical endeavors and potential future commercial exploits involving molecules derived from 177Lu.

The agreement stipulates that Radiopharm will deploy ITM's n.c.a. 177Lu across its clinical projects. This includes critical programs such as RAD 204, which targets PD-L1 nanobodies and is in Phase 1; RAD 202, focused on HER2-targeting nanobodies also in Phase 1; and RV01, a B7-H3-targeting monoclonal antibody currently at the preclinical stage. These initiatives aim to combat solid tumors. By coupling ITM’s n.c.a. 177Lu with targeting molecules that direct the radioisotope to tumor sites, it emits beta radiation intended to obliterate malignant cells with precision.

Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics, emphasized the significance of securing key isotopes to further their clinical programs. He noted, “Lutetium-177 is essential for three of our leading assets, and partnering with ITM ensures quality and reliability in our clinical development plans.”

ITM’s n.c.a. 177Lu is a highly pure form of the beta-emitting radioisotope Lutetium-177. It can be conjugated with tumor-specific targeting molecules, offering a treatment method for various cancers. This radioisotope has already been utilized successfully in numerous clinical and commercial radiopharmaceutical cancer therapies. ITM possesses a U.S. Drug Master File (DMF) with the FDA for n.c.a. 177Lu and holds marketing approval in the EU under the brand name EndolucinBeta®.

Andrew Cavey, CEO of ITM, remarked on their commitment to supplying global partners with medical radioisotopes while advancing their therapeutic candidates. He stated, “Supporting Radiopharm reflects our shared dedication to improving treatment options for cancer patients.”

ITM Isotope Technologies Munich SE is at the forefront of developing radiopharmaceutical therapeutics and diagnostics aimed at challenging tumors. Their mission focuses on enhancing patient care through excellence in development, production, and global distribution. ITM's precision oncology pipeline includes several Phase 3 studies that integrate their high-quality radioisotopes with various targeting molecules, driven by a commitment to improving patient outcomes and quality of life.

Radiopharm Theranostics, meanwhile, is a clinical-stage company dedicated to creating a platform of innovative radiopharmaceutical products for both diagnostic and therapeutic applications. Their pipeline features diverse technologies, including peptides, small molecules, and monoclonal antibodies targeted at cancer treatment. Radiopharm’s clinical programs encompass one Phase 2 trial and three Phase 1 trials across various solid tumor types, including lung, breast, and brain cancers.

The collaboration between ITM and Radiopharm represents a significant stride in the development of targeted cancer therapies, showcasing the potential of radiopharmaceutical products in advancing cancer treatment.