ITM and Radiopharm Sign Supply Agreement for n.c.a. Lutetium-177
ITM Isotope Technologies Munich and Radiopharm Theranostics (NASDAQ: RADX) have signed a supply agreement for non-carrier-added Lutetium-177 (n.c.a. 177Lu). Under the agreement, Radiopharm will use ITM's n.c.a. 177Lu across its clinical pipeline, including RAD 204 (PD-L1-targeting nanobody, Phase 1), RAD 202 (HER2-targeting nanobody, Phase 1), and RV01 (B7-H3-targeting monoclonal antibody, preclinical) for solid tumor treatment.
ITM's n.c.a. 177Lu is a market-approved radioisotope that can be linked to tumor-specific targeting molecules. The company holds a U.S. Drug Master File with the FDA and has EU marketing authorization under the brand name EndolucinBeta®.
ITM Isotope Technologies Munich e Radiopharm Theranostics (NASDAQ: RADX) hanno firmato un accordo di fornitura per il Lutetio-177 non carrier-added (n.c.a. 177Lu). Secondo l'accordo, Radiopharm utilizzerà il n.c.a. 177Lu di ITM in tutta la sua pipeline clinica, includendo RAD 204 (nanocorpo che mira a PD-L1, Fase 1), RAD 202 (nanocorpo che mira a HER2, Fase 1) e RV01 (anticorpo monoclonale che mira a B7-H3, preclinico) per il trattamento di tumori solidi.
Il n.c.a. 177Lu di ITM è un radioisotopo approvato sul mercato che può essere coniugato a molecole specifiche per il targeting tumorale. L'azienda possiede un Drug Master File negli Stati Uniti presso la FDA e ha l'autorizzazione alla commercializzazione nell'UE con il nome commerciale EndolucinBeta®.
ITM Isotope Technologies Munich y Radiopharm Theranostics (NASDAQ: RADX) han firmado un acuerdo de suministro para Lutecio-177 sin portador añadido (n.c.a. 177Lu). Según el acuerdo, Radiopharm utilizará el n.c.a. 177Lu de ITM en toda su cartera clínica, incluyendo RAD 204 (nanocuerpo dirigido a PD-L1, Fase 1), RAD 202 (nanocuerpo dirigido a HER2, Fase 1) y RV01 (anticuerpo monoclonal dirigido a B7-H3, preclínico) para el tratamiento de tumores sólidos.
El n.c.a. 177Lu de ITM es un radioisótopo aprobado en el mercado que puede unirse a moléculas específicas para el targeting tumoral. La compañía posee un Drug Master File en EE.UU. con la FDA y cuenta con autorización de comercialización en la UE bajo el nombre comercial EndolucinBeta®.
ITM Isotope Technologies Munich와 Radiopharm Theranostics (NASDAQ: RADX)가 비운반체 첨가 루테튬-177(n.c.a. 177Lu) 공급 계약을 체결했습니다. 이 계약에 따라 Radiopharm은 ITM의 n.c.a. 177Lu를 임상 파이프라인 전반에 걸쳐 사용하며, 여기에는 고형암 치료를 위한 RAD 204(PD-L1 표적 나노바디, 1상), RAD 202(HER2 표적 나노바디, 1상), RV01(B7-H3 표적 단클론 항체, 전임상)이 포함됩니다.
ITM의 n.c.a. 177Lu는 종양 특이적 표적 분자에 결합할 수 있는 시장 승인된 방사성 동위원소입니다. 회사는 FDA에 미국용 Drug Master File을 보유하고 있으며, EndolucinBeta®라는 브랜드명으로 EU 마케팅 허가를 받았습니다.
ITM Isotope Technologies Munich et Radiopharm Theranostics (NASDAQ : RADX) ont signé un accord de fourniture pour le Lutétium-177 sans porteur ajouté (n.c.a. 177Lu). Selon cet accord, Radiopharm utilisera le n.c.a. 177Lu d’ITM dans l’ensemble de son pipeline clinique, incluant RAD 204 (nanocorps ciblant PD-L1, phase 1), RAD 202 (nanocorps ciblant HER2, phase 1) et RV01 (anticorps monoclonal ciblant B7-H3, préclinique) pour le traitement des tumeurs solides.
Le n.c.a. 177Lu d’ITM est un radioisotope approuvé sur le marché pouvant être lié à des molécules spécifiques ciblant les tumeurs. La société détient un Drug Master File aux États-Unis auprès de la FDA et bénéficie d’une autorisation de mise sur le marché en UE sous le nom commercial EndolucinBeta®.
ITM Isotope Technologies Munich und Radiopharm Theranostics (NASDAQ: RADX) haben eine Liefervereinbarung für nicht-trägergebundenes Lutetium-177 (n.c.a. 177Lu) unterzeichnet. Im Rahmen der Vereinbarung wird Radiopharm ITMs n.c.a. 177Lu in seiner klinischen Pipeline verwenden, einschließlich RAD 204 (nanobody, der PD-L1 anvisiert, Phase 1), RAD 202 (nanobody, der HER2 anvisiert, Phase 1) und RV01 (monoklonaler Antikörper, der B7-H3 anvisiert, präklinisch) zur Behandlung solider Tumore.
ITMs n.c.a. 177Lu ist ein marktzugelassener Radioisotop, das an tumorspezifische Zielmoleküle gekoppelt werden kann. Das Unternehmen besitzt ein US Drug Master File bei der FDA und hat eine EU-Marktzulassung unter dem Markennamen EndolucinBeta®.
- Agreement secures supply of crucial radioisotope for three advanced assets in Radiopharm's pipeline
- Partnership with a leading radiopharmaceutical manufacturer ensures quality and reliability
- ITM's Lutetium-177 is already market-approved with FDA Drug Master File and EU authorization
- Multiple pipeline products still in early development phases (Phase 1 or preclinical)
- Success depends on clinical trial outcomes of the therapeutic candidates
Insights
Radiopharm secures critical Lutetium-177 supply from ITM for three early-stage cancer programs, reducing development risk without immediate financial impact.
This supply agreement between Radiopharm Theranostics and ITM addresses a critical operational need in Radiopharm's clinical development pipeline. Non-carrier-added Lutetium-177 (n.c.a.
The agreement specifically covers three of Radiopharm's development programs:
- RAD 204 (PD-L1-targeting nanobody) - Phase 1
- RAD 202 (HER2-targeting nanobody) - Phase 1
- RV01 (B7-H3-targeting monoclonal antibody) - Preclinical
In radiopharmaceutical development, securing reliable isotope supply represents a fundamental requirement rather than a luxury. These specialized materials present unique supply chain challenges due to their limited half-lives, specialized handling requirements, and complex production processes. By partnering with ITM, which holds significant regulatory recognitions including an FDA Drug Master File and EU marketing authorization for EndolucinBeta®, Radiopharm effectively reduces a key operational risk in their development pathway.
The agreement demonstrates strategic foresight from Radiopharm's management to establish supply redundancy and reliability - aspects specifically highlighted by CEO Riccardo Canevari as priorities. For radiopharmaceutical developers, isotope supply constraints can severely impact clinical trial timelines, so this agreement represents an important de-risking event for Radiopharm's early-stage pipeline.
While financial terms and agreement duration remain undisclosed, this arrangement constitutes an important operational foundation rather than a transformative business development. Considering the early clinical stage of the relevant programs (Phase 1 and preclinical), any commercial impact remains distant and contingent on successful clinical development.
GARCHING / MUNICH, Germany and SYDNEY, May 19, 2025 (GLOBE NEWSWIRE) -- 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 pipeline.
Under the terms of the agreement, Radiopharm will use ITM’s n.c.a. 177Lu 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.
“Ensuring 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.”
ITM’s 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®).
“As 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.”
About ITM 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. www.itm-radiopharma.com
About Radiopharm Theranostics
Radiopharm 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.
For more information:
Riccardo Canevari
CEO & Managing Director
P: +1 862 309 0293
E: rc@radiopharmtheranostics.com
Paul Hopper
Executive Chairman
P: +61 406 671 515
E: paulhopper@lifescienceportfolio.com
Media
Matt Wright
NWR Communications
P: +61 451 896 420
E: matt@nwrcommunications.com.au
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
FAQ
What is the purpose of the supply agreement between ITM and Radiopharm Theranostics (RADX)?
Which clinical programs will use ITM's Lutetium-177 at Radiopharm Theranostics (RADX)?
What regulatory approvals does ITM's Lutetium-177 currently have?
How does Lutetium-177 work in cancer treatment?
