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Highlights
- Radiopharm has signed a supply a with ITM for high-purity non-carrier-added Lutetium-177 (n.c.a.¹⁷⁷Lu).
- The agreement has secured a critical radioisotope supply for Radiopharm’s clinical and preclinical cancer programs.
- ITM’s n.c.a.¹⁷⁷Lu is FDA-registered and EU-approved under the brand EndolucinBeta®.
- Radiopharm’s CEO, Riccardo Canevari, described the agreement as a major step toward ensuring clinical reliability and accelerating development timelines.
- RAD shares up 5% after the update.
Radiopharm Theranostics Ltd (ASX: RAD; NASDAQ: RADX), a clinical-stage radiotherapeutics company, has announced a significant milestone through a newly signed supply agreement with ITM Isotope Technologies Munich SE (ITM), a global leader in radiopharmaceutical biotechnology. Under this deal, Radiopharm will gain access to ITM’s medical radioisotope, non-carrier-added Lutetium-177 (n.c.a. 177Lu), a critical isotope used in targeted cancer therapies.
Key Isotope to be Integrated Across Lead Programs
The agreement marks a crucial step in the advancement of Radiopharm’s pipeline of radiopharmaceutical products. ITM’s n.c.a.¹⁷⁷Lu will be integrated into multiple Radiopharm’s clinical and preclinical programs, including RAD 204 (a PD-L1-targeting nanobody in Phase 1), RAD 202 (a HER2-targeting nanobody, also in Phase 1), and RV01 (a B7-H3-targeting monoclonal antibody in preclinical development). Coupled with the targeting molecules that are designed to deliver ITM’s n.c.a. 177Lu directly to tumour sites, the radioisotope emits therapeutic beta radiation with the aim to destroy malignant cells in a highly precise and localised manner.
About Lutetium-177 and ITM’s Supply
Lutetium-177 is a beta-emitting radioisotope that has shown promising therapeutic efficacy in various cancer indications. ITM’s n.c.a.¹⁷⁷Lu is recognised for its high purity and clinical-grade quality, with regulatory approvals in both the U.S. and EU (marketed as EndolucinBeta®). ITM holds a U.S. Drug Master File (DMF) with the FDA for n.c.a. 177Lu and has marketing authorization in the EU. The radioisotope has ability to bind with tumour-specific molecules and emit targeted radiation.
“Ensuring supply of key isotopes continues to be a priority for our team, allowing us to accelerate our clinical programs. 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,” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics.
Radiopharm’s stock traded at AUD 0.023, up 4.55%, at the time of writing on 19 May 2025.
