Cellectar Biosciences and NorthStar Medical Radioisotopes Announce Partnership for Supply of Actinium-225
Cellectar Biosciences (NASDAQ: CLRB) has signed a strategic 10-year supply agreement with NorthStar Medical Radioisotopes for non-carrier-added Actinium-225 (Ac-225), a rare radioisotope essential for cancer treatment. The agreement supports Cellectar's CLR 121225 development program, which combines their Phospholipid Ether delivery platform with Ac-225 for solid tumor treatment.
The company plans to begin human clinical trials in 2025, following promising preclinical results in pancreatic, triple negative breast, and other solid tumors. This partnership addresses the critical challenge of Ac-225 scarcity in clinical development and commercialization, securing a reliable supply source for Cellectar's radiotherapeutic development strategy.
Cellectar Biosciences (NASDAQ: CLRB) ha firmato un accordo strategico di fornitura di 10 anni con NorthStar Medical Radioisotopes per l'Actinium-225 (Ac-225) non addizionato, un raro radioisotopo fondamentale per il trattamento del cancro. L'accordo supporta il programma di sviluppo CLR 121225 di Cellectar, che combina la loro piattaforma di consegna Phospholipid Ether con Ac-225 per il trattamento dei tumori solidi.
L'azienda prevede di avviare le sperimentazioni cliniche sugli esseri umani nel 2025, dopo risultati preclinici promettenti in tumori pancreatici, mammari tripli negativi e altri tumori solidi. Questa partnership affronta la sfida critica della scarsità di Ac-225 nello sviluppo clinico e nella commercializzazione, garantendo una fonte di fornitura affidabile per la strategia di sviluppo radioterapeutico di Cellectar.
Cellectar Biosciences (NASDAQ: CLRB) ha firmado un acuerdo estratégico de suministro de 10 años con NorthStar Medical Radioisotopes para el Actinio-225 (Ac-225) no añadido, un raro radioisótopo esencial para el tratamiento del cáncer. El acuerdo apoya el programa de desarrollo CLR 121225 de Cellectar, que combina su plataforma de entrega de Éter Fosfolipídico con Ac-225 para el tratamiento de tumores sólidos.
La empresa planea comenzar ensayos clínicos en humanos en 2025, después de resultados preclínicos prometedores en tumores pancreáticos, de mama triplemente negativos y otros tumores sólidos. Esta asociación aborda el desafío crítico de la escasez de Ac-225 en el desarrollo clínico y la comercialización, asegurando una fuente de suministro confiable para la estrategia de desarrollo radioterapéutico de Cellectar.
셀렉타 바이오사이언스(Cellectar Biosciences) (NASDAQ: CLRB)는 노스스타 메디컬 라디오아이소토프(NorthStar Medical Radioisotopes)와 비보조제로 추가된 아크티늄-225(Actinium-225, Ac-225)에 대해 10년 간의 전략적 공급 계약을 체결했습니다. 이 드문 방사성 동위원소는 암 치료에 필수적입니다. 이 계약은 셀렉타의 CLR 121225 개발 프로그램을 지원하며, 이는 그들의 인지질 에테르 전달 플랫폼과 Ac-225를 결합하여 고형 종양 치료에 사용됩니다.
회사는 췌장암, 삼중 음성 유방암 및 기타 고형 종양에서 유망한 전임상 결과를 바탕으로 2025년에 인간 임상 시험을 시작할 계획입니다. 이 파트너십은 임상 개발과 상용화 과정에서 Ac-225의 부족이라는 중대한 과제를 해결하며, 셀렉타의 방사선 치료 개발 전략을 위한 신뢰할 수 있는 공급원을 확보합니다.
Cellectar Biosciences (NASDAQ: CLRB) a signé un accord de fourniture stratégique de 10 ans avec NorthStar Medical Radioisotopes pour l'Actinium-225 (Ac-225) non additif, un radioisotope rare essentiel pour le traitement du cancer. Cet accord soutient le programme de développement CLR 121225 de Cellectar, qui combine leur plateforme de livraison d'Éther Phospholipidique avec l'Ac-225 pour le traitement des tumeurs solides.
L'entreprise prévoit de commencer les essais cliniques chez l'homme en 2025, suite à des résultats précliniques prometteurs dans les tumeurs pancréatiques, les cancers du sein triple négatif et d'autres tumeurs solides. Ce partenariat répond au défi critique de la rareté de l'Ac-225 dans le développement clinique et la commercialisation, garantissant une source d'approvisionnement fiable pour la stratégie de développement radiothérapeutique de Cellectar.
Cellectar Biosciences (NASDAQ: CLRB) hat einen strategischen Liefervertrag über 10 Jahre mit NorthStar Medical Radioisotopes für nicht-trägerspezifisches Actinium-225 (Ac-225) unterzeichnet, ein seltener Radioisotop, der für die Krebsbehandlung unerlässlich ist. Der Vertrag unterstützt das Entwicklungsprogramm CLR 121225 von Cellectar, das ihre Phospholipid-Ether-Lieferplattform mit Ac-225 für die Behandlung von soliden Tumoren kombiniert.
Das Unternehmen plant, 2025 mit klinischen Studien am Menschen zu beginnen, nachdem vielversprechende präklinische Ergebnisse bei Pankreastumoren, triple-negativen Brusttumoren und anderen soliden Tumoren erzielt wurden. Diese Partnerschaft geht die kritische Herausforderung des Mangels an Ac-225 in der klinischen Entwicklung und Kommerzialisierung an und sichert eine zuverlässige Versorgungsquelle für die radiotherapeutische Entwicklungsstrategie von Cellectar.
- Secured 10-year strategic supply agreement for rare Ac-225 radioisotope
- Promising preclinical results in multiple solid tumor types
- Clinical trials planned for 2025
- Product is still investigational and not approved by regulators
- Clinical trials haven't started yet, indicating long path to potential commercialization
Insights
This strategic partnership marks a significant development in radiopharmaceutical supply chain management. The 10-year agreement secures a reliable source of Actinium-225, a rare and important radioisotope for Cellectar's CLR 121225 program. This addresses a major industry bottleneck, as Ac-225 supply constraints have historically the development of alpha-emitting radiotherapeutics.
The deal strengthens Cellectar's position in developing targeted alpha therapies (TATs) for solid tumors, particularly in pancreatic and triple negative breast cancers. Their proprietary PLE delivery platform, combined with secured Ac-225 supply, provides a competitive advantage in the growing radiopharmaceutical market. The planned clinical trials in 2025 now have reduced supply chain risk, enhancing the program's execution probability.
The agreement represents a strategic solution to a critical supply chain challenge in the radiopharmaceutical industry. NorthStar's ability to provide non-carrier added (n.c.a.) Ac-225 through environmentally preferred production methods differentiates this partnership. The 10-year duration of the supply agreement provides long-term stability, supporting not only clinical development but potential commercialization phases.
This partnership mitigates a significant operational risk, as radioisotope supply chains are notoriously fragile and complex due to short half-lives and specialized handling requirements. For Cellectar, securing a dedicated supply line eliminates a major barrier to program advancement and potential market entry.
NorthStar to provide Cellectar with non-carrier-added Ac-225 for its expanded portfolio of clinical programs
FLORHAM PARK, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB) a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the signing of a strategic supply agreement with NorthStar Medical Radioisotopes, LLC, for the procurement of NorthStar’s non-carrier added (n.c.a.) Ac-225. The Company’s CLR 121225 development program combines its proprietary Phospholipid Ether (PLE) delivery platform and actinium 225 for the treatment of solid tumors.
Existing supply chains for medical radioisotopes are often strained, posing a challenge to patient care, clinical trials, and ongoing drug development. Actinium-225 (Ac-225) is considered a rare radioisotope and is in short supply for clinical development and commercialization.
“Our PLE platform provides a unique ability to optimize delivery of any radioisotope and can be designed for the treatment of specific tumor types. Our leading alpha emitter program, CLR 121225, utilizes Ac-225 and has demonstrated promising preclinical results in pancreatic, triple negative breast and other solid tumors, justifying the progression to clinical development,” said James Caruso, president and CEO of Cellectar. “We plan to advance CLR 121225 into human clinical trials in 2025 as part of a broader strategy to bring first-and best-in-class radiotherapeutics to market. This agreement with NorthStar provides a reliable source of Ac-225, which is a critical to our clinical development strategy.”
NorthStar is a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging including non-carrier added (n.c.a) Ac-225.
“Recent years have seen increased interest in alpha-emitting radiotherapies like Cellectar’s novel TAT compounds, including CLR 121225 and others, but development activities have been hampered by the relative scarcity of Ac-225 supply,” said Frank Scholz, president and CEO of NorthStar. “Our passion is to reduce technological and operational barriers to give companies like Cellectar a reliable source of environmentally preferred, high purity (n.c.a) Ac-225 that will help make these new therapies possible.”
The agreement provides supply of Ac-225 from NorthStar for 10 years, and initiation is expected to occur in 2025.
CLR 121225 is an investigational therapy and not yet approved by any regulatory authority.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage radiopharmaceutical company at the forefront of advancing patient care by utilizing novel technologies to produce commercial-scale radioisotopes that, once attached to a molecule, have the ability to detect and treat cancer and other serious diseases. NorthStar’s expanding industry-leading position in the emerging field of radiopharmaceutical therapy is supported by its unique capabilities in the sophisticated production of radioisotopes, proven management team, and state-of-the-art, environmentally preferable technologies. NorthStar routinely produces copper-67 (Cu-67) and is poised to be the first commercial-scale producer of non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s Radiopharmaceutical Contract Development and Manufacturing Organization (CDMO) services unit provides customized service offerings and specialized radiopharmaceutical expertise to help biopharmaceutical companies rapidly advance their development and commercial programs. For more information about NorthStar’s comprehensive portfolio and patient-focused services, visit: www.northstarnm.com.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of novel 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 lead asset iopofosine I 131, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.
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 including our expectations regarding the CLOVER WaM pivotal trial. 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 raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. 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/A for the year ended December 31, 2023, and our Form 10-Q for the quarter ended June 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
Contacts
MEDIA:
Christy Maginn
Bliss Bio Health
703-297-7194
cmaginn@blissbiohealth.com
INVESTORS:
Anne Marie Fields
Precision AQ (formerly Stern IR)
annemarie.fields@precisionaq.com
FAQ
What is the purpose of Cellectar's (CLRB) partnership with NorthStar Medical Radioisotopes?
When will Cellectar (CLRB) begin clinical trials for CLR 121225?
What types of cancer has Cellectar's (CLRB) CLR 121225 shown promising results for?
