Full Press Release Details
and Radiopharm Sign Supply Agreement for n.c.a. Lutetium-177
/ Munich, Germany and Sydney, Australia, May 19 2025 - ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical
biotech company, and Radiopharm Theranostics (ASX:RAD; NASDAQ: RADX "Radiopharm"), a developer of a world-class platform
of radiopharmaceutical products for both diagnostic and therapeutic uses, today announced the signing of a supply agreement that will
provide Radiopharm with ITM's medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu), to enable its usage
in the clinical and potential future commercial development of the 177Lu-based molecules in Radiopharm's development
the terms of the agreement, Radiopharm will use ITM's n.c.a. ¹ Lu across its clinical pipeline, including in
key programs such as RAD 204 (PD-L1-targeting nanobody, Phase 1), RAD 202 (HER2-targeting nanobody, Phase 1), and RV01 (B7-H3-targeting
monoclonal antibody, preclinical), for the treatment of solid tumors. Coupled with the targeting molecules that are designed to deliver
ITM's n.c.a. 177Lu directly to tumor sites, the radioisotope emits therapeutic beta radiation with the aim to destroy
malignant cells in a highly precise and localized manner.
supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs," said Riccardo
Canevari, CEO and Managing Director of Radiopharm Theranostics. "Lutetium-177 is required for three of our more advanced
assets and this supply agreement with a radiopharmaceutical leader like ITM is another important step to ensure quality, reliability,
and redundancy in our clinical development plans."
n.c.a. 177Lu is a market-approved, highly pure form of the beta-emitting radioisotope,
Lutetium-177, that can be linked to tumor-specific targeting molecules for the treatment of various cancers and has been successfully
used in numerous clinical and commercial radiopharmaceutical cancer treatments. ITM holds a U.S. Drug Master File (DMF) with the Food
and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta ).
the leading global manufacturer of non-carrier-added Lutetium-177, we are just as committed to supplying our global partners with high-quality
medical radioisotopes as we are to supplying our own pipeline," said Andrew Cavey, CEO of ITM. "Supporting
Radiopharm in the advancement of their therapeutic candidates reflects our shared dedication to delivering improved treatment options
to people living with cancer."
Isotope Technologies Munich SE
ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics
and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence
in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad
precision oncology pipeline, including multiple phase 3 studies, combining the company's high-quality radioisotopes with a range
of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established
global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcome and quality of life.
Radiopharm Theranostics
Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products
for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm is listed on ASX (RAD) and on NASDAQ (RADX).
The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal
antibodies for use in cancer. The clinical program includes one Phase 2 and three Phase 1 trials in a variety of solid tumor cancers
including lung, breast, and brain. Learn more at radiopharmtheranostics.com.
Authorised on behalf of the Radiopharm Theranostics board
of directors by Chairman Paul Hopper.
CEO & Managing Director
Corporate Communications
Kathleen Noonan/Julia Westermeir
Phone: +49 89 329 8986 1500
Phone: +49 89 329 8986 1009