Cellectar Biosciences and ITM Enter Supply Agreement for GMP-Grade Actinium-225
Cellectar Biosciences (NASDAQ:CLRB) has entered into a supply agreement with ITM Isotope Technologies Munich SE for Actinium-225 (Ac-225), a crucial isotope for targeted cancer therapies. The agreement will support the clinical development of Cellectar's CLR 121225, a Phase 1-ready compound for treating solid tumors, particularly pancreatic cancer.
The partnership addresses the critical challenge of Ac-225 scarcity in radiopharmaceutical development. ITM, through its joint venture Actineer with Canadian Nuclear Laboratories, will provide Cellectar with medical-grade Ac-225. CLR 121225 has shown promising anti-tumor effects in preclinical studies, utilizing Cellectar's proprietary phospholipid ether (PLE) delivery platform for selective cancer cell targeting.
Cellectar Biosciences (NASDAQ:CLRB) ha sottoscritto un accordo di fornitura con ITM Isotope Technologies Munich SE per l'Actinio-225 (Ac-225), un isotopo fondamentale per terapie mirate contro il cancro. L'intesa supporterà lo sviluppo clinico di CLR 121225 di Cellectar, un composto pronto per la Fase 1 per il trattamento dei tumori solidi, con particolare attenzione al cancro del pancreas.
La collaborazione affronta la delicata questione della scarsità di Ac-225 nello sviluppo dei radiofarmaci. ITM, tramite la joint venture Actineer con i Canadian Nuclear Laboratories, fornirà a Cellectar Ac-225 di grado medico. CLR 121225 ha mostrato effetti antitumorali promettenti negli studi preclinici, sfruttando la piattaforma proprietaria di Cellectar basata su eteri fosfolipidici (PLE) per il rilascio selettivo verso le cellule tumorali.
Cellectar Biosciences (NASDAQ:CLRB) ha firmado un acuerdo de suministro con ITM Isotope Technologies Munich SE para el Actinio-225 (Ac-225), un isótopo clave en terapias oncológicas dirigidas. El acuerdo respaldará el desarrollo clínico de CLR 121225 de Cellectar, un compuesto listo para Fase 1 destinado al tratamiento de tumores sólidos, especialmente el cáncer de páncreas.
La asociación responde al problema crítico de la escasez de Ac-225 en el desarrollo de radiofármacos. ITM, a través de su joint venture Actineer con Canadian Nuclear Laboratories, proporcionará a Cellectar Ac-225 de grado médico. CLR 121225 ha mostrado efectos antitumorales prometedores en estudios preclínicos, utilizando la plataforma de entrega propietaria de Cellectar basada en éter fosfolípido (PLE) para dirigir selectivamente las células cancerosas.
Cellectar Biosciences (NASDAQ:CLRB)가 표적 항암 치료에 필수적인 동위원소인 아크티늄-225(Ac-225) 공급을 위해 ITM Isotope Technologies Munich SE와 공급 계약을 체결했습니다. 이번 계약은 고형 종양, 특히 췌장암 치료를 목표로 한 Cellectar의 Fase 1 준비 완료 물질 CLR 121225의 임상 개발을 지원합니다.
이번 파트너십은 방사성 의약품 개발에서 중요한 과제인 Ac-225 부족 문제를 해결합니다. ITM은 캐나다 원자력연구소(Canadian Nuclear Laboratories)와의 합작사 Actineer를 통해 의료용 등급의 Ac-225를 Cellectar에 공급할 예정입니다. CLR 121225는 전임상 연구에서 유망한 항종양 효과를 보였으며, Cellectar의 독자적 인지질 에테르(PLA) 전달 플랫폼을 활용해 암세포를 선택적으로 표적합니다.
Cellectar Biosciences (NASDAQ:CLRB) a conclu un accord d'approvisionnement avec ITM Isotope Technologies Munich SE pour l'actinium‑225 (Ac‑225), un isotope essentiel aux thérapies ciblées contre le cancer. Cet accord soutiendra le développement clinique de CLR 121225 de Cellectar, un composé prêt pour la phase 1 destiné au traitement des tumeurs solides, en particulier du cancer du pancréas.
Le partenariat répond au défi majeur de la pénurie d'Ac‑225 dans le développement des radiopharmaceutiques. ITM, via sa co‑entreprise Actineer avec Canadian Nuclear Laboratories, fournira à Cellectar de l'Ac‑225 de qualité médicale. CLR 121225 a montré des effets antitumoraux prometteurs en études précliniques, utilisant la plateforme propriétaire de délivrance par éther phospholipidique (PLE) de Cellectar pour cibler sélectivement les cellules cancéreuses.
Cellectar Biosciences (NASDAQ:CLRB) hat einen Liefervertrag mit ITM Isotope Technologies Munich SE über Actinium-225 (Ac-225) abgeschlossen, ein entscheidendes Isotop für zielgerichtete Krebstherapien. Der Vertrag soll die klinische Entwicklung von Cellectars CLR 121225 unterstützen, einem für Phase‑1 bereitstehenden Wirkstoff zur Behandlung solider Tumoren, insbesondere des Pankreaskarzinoms.
Die Partnerschaft adressiert die zentrale Herausforderung der Ac-225‑Knappheit in der Radiopharmazeutik. ITM wird über das Joint Venture Actineer mit den Canadian Nuclear Laboratories medizinisches Ac-225 an Cellectar liefern. CLR 121225 zeigte in präklinischen Studien vielversprechende antitumorale Effekte und nutzt Cellectars proprietäre Phospholipid‑Ether( PLE )‑Plattform für eine selektive Anreicherungs‑ und Abgabestrategie in Krebszellen.
- None.
- Current scarcity of high-quality Ac-225 could impact development timeline
- Early-stage development status (Phase 1-ready) indicates long path to commercialization
Insights
Cellectar secures crucial Actinium-225 supply for its cancer pipeline, addressing a key development constraint in targeted alpha therapy advancement.
Cellectar's supply agreement with ITM for Actinium-225 (Ac-225) represents a significant operational milestone in the company's radiopharmaceutical development program. This partnership addresses a critical industry bottleneck - the scarcity of high-quality Ac-225 has been a major limiting factor for companies developing alpha-emitting radiotherapeutics. By securing this supply, Cellectar removes a key impediment to advancing its CLR 121225 program for solid tumors, particularly pancreatic cancer.
The agreement enhances Cellectar's competitive positioning in the rapidly evolving radiopharmaceutical landscape. Actinium-225 is particularly valuable in cancer therapeutics because it emits powerful alpha particles that can effectively destroy cancer cells while minimizing damage to surrounding healthy tissue due to their short tissue penetration range. This makes it ideal for targeting micrometastases and difficult-to-treat solid tumors.
Importantly, Cellectar has strategically constructed a network of Ac-225 suppliers rather than relying on a single source, which mitigates supply chain risk for this rare isotope. The partnership with ITM, which brings two decades of isotope manufacturing experience through its Actineer joint venture with Canadian Nuclear Laboratories, provides Cellectar with access to one of the few reliable production sources globally.
For investors, this agreement reduces a significant execution risk in Cellectar's clinical development pathway, potentially accelerating the timeline for its Phase 1-ready compound CLR 121225. The company's phospholipid ether (PLE) delivery platform, combined with secured access to this scarce therapeutic isotope, strengthens its position in the competitive landscape of targeted radiotherapeutics for solid tumors.
Supports Clinical Development of CLR 121225, Actinium-Labeled Compound for the Treatment of Solid Tumors
FLORHAM PARK, N.J. and GARCHING, Germany and MUNICH, Germany, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (Nasdaq: CLRB, “Cellectar”), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, and ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced a supply agreement for Actinium-225 (Ac-225). The agreement will support the clinical development of Cellectar’s actinium-labeled phospholipid ether (PLE) radiopharmaceutical candidates, including its Phase 1-ready compound, CLR 121225, for the treatment of solid tumors.
CLR 121225 (225Ac-CLR 121225), a novel actinium-labeled PLE, is under investigation for the treatment of solid tumors, including pancreatic cancer. Cellectar’s proprietary PLE delivery platform allows for the design and development of novel radiopharmaceuticals that can selectively target and eradicate cancer cells. ITM is leveraging its two decades of medical isotope manufacturing to scale supplies of Ac-225 to ensure rapid, reliable isotope delivery.
“Our lead alpha-emitting program, CLR 121225, has demonstrated excellent anti-tumor effects in preclinical studies, especially in pancreatic cancer,” said James Caruso, chief executive officer of Cellectar. “Our agreement with ITM supports our strategic approach to ensure a continuous, high-quality supply of Actinium-225 required to advance our pipeline candidates and to fully explore the potential benefits of this targeted alpha therapy for cancer patients.”
Ac-225 is an important isotope for the development of next-generation radiopharmaceuticals, serving as a powerful alpha-emitting isotope used in targeted cancer therapies. The scarcity of high-quality Ac-225 has slowed the advancement of research and development of Ac-225 based programs. To overcome this challenge and support the timely advancement of its pipeline, Cellectar has constructed a network of Ac-225 suppliers ensuring access to a sufficient supply.
“This agreement reflects our strategic commitment to advancing global access to radiopharmaceuticals,” said Dr. Andrew Cavey, chief executive officer of ITM. “We value our partnership with Cellectar and our shared belief in the potential of innovative radiopharmaceutical therapies to significantly improve outcomes for patients with cancer. With more than two decades of leadership in the field, a fully vertically integrated model, and our joint venture, Actineer, ITM is uniquely positioned to meet the growing global demand for this critical isotope.”
Under the terms of the agreement, ITM will supply Cellectar with the required quantities to facilitate the clinical development of its therapeutic medical grade radioisotope, Ac-225, produced by Actineer™ Inc., the joint venture between ITM and Canadian Nuclear Laboratories. Reliable, scalable production sites are crucial to meet the growing demand for Ac-225, given limited supply and manufacturing complexities surrounding the isotope.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope), for which the FDA has granted Breakthrough Therapy Designation; CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.
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 Actineer, Inc.
Actineer™ Inc. is a joint venture company between Canadian Nuclear Laboratories (CNL) and ITM Isotope Technologies Munich SE (ITM) dedicated to advancing Ac-225 technologies, quickly securing supply, and producing industrial-scale quantities of this valuable, rare medical radioisotope for the treatment of cancer. Founded in October 2023, Actineer™ Inc. together with its strong supply chain collaborators seeks to progress Ac-225 development, production, and processing technologies. It has established short-term production capabilities that is expected to lead to significantly boosting international supplies, while working long-term towards the construction of a new Actinium Production Facility (APF) in Canada. The joint venture’s mission is to fulfil the unmet global manufacturing and production needs of this coveted radioisotope with significant potential in the fight against cancer.
Forward-Looking Statement Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarter ended March 31, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
Cellectar Biosciences Contact
Investors:
Anne Marie Fields
Precision AQ
Phone: +1 212-362-1200
Email: annemarie.fields@precisionaq.com
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 Cellectar's (CLRB) supply agreement with ITM?
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Why is the Actinium-225 supply agreement significant for CLRB?
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