NorthStar Medical Radioisotopes Executes Supply Agreement With Cellectar Biosciences for Therapeutic Radioisotope Actinium-225 (Ac-225)

Rhea-AI Summary

NorthStar Medical Radioisotopes has signed a Master Supply Agreement with Cellectar Biosciences (NASDAQ: CLRB) to provide non-carrier added actinium-225 (n.c.a Ac-225) for Cellectar's radiotherapeutic development programs. The agreement will support Cellectar's CLR 121225, an actinium-labeled phospholipid ether (PLE) therapy, which has shown promising preclinical results in pancreatic, triple negative breast, and other solid tumors. The company plans to initiate Phase 1 clinical trials for CLR 121225 in pancreatic cancer in 2025. This partnership aims to address the scarcity of Ac-225 supply in radiotherapy development.

Positive

• Secured strategic supply agreement for critical Ac-225 radioisotope
• CLR 121225 showed promising preclinical results in multiple tumor types
• Phase 1 clinical trials planned for 2025 in pancreatic cancer

Negative

• Clinical trials not starting until 2025
• Product still in preclinical stage with no human data available

Insights

Biotech Research Analyst

This supply agreement marks a significant milestone for Cellectar's radiopharmaceutical development program. Securing a reliable source of n.c.a Ac-225 is important for advancing CLR 121225, their alpha-emitter program targeting pancreatic cancer and other solid tumors. The deal addresses a critical industry bottleneck, as Ac-225 scarcity has historically hindered radiotherapeutic development.

The partnership strengthens Cellectar's clinical development pipeline, particularly supporting their planned Phase 1 trial in 2025. Their PLE delivery platform's ability to optimize radioisotope delivery for specific tumor types, combined with NorthStar's high-purity Ac-225 supply, positions them competitively in the growing targeted alpha therapy (TAT) market.

Notably, preclinical results in pancreatic and triple-negative breast cancers have shown promise, justifying clinical progression. This agreement reduces execution risk for Cellectar's development programs and enhances their ability to advance potential first-in-class radiotherapeutics.

• NorthStar to provide non-carrier added actinium-225 (n.c.a Ac-225) to Cellectar for use in its expanded portfolio of clinical programs
• This includes CLR 121225 an actinium-labeled phospholipid ether (PLE), expected to enter a Phase 1 study in pancreatic cancer in 2025

BELOIT, Wis.--(BUSINESS WIRE)-- NorthStar Medical Radioisotopes, LLC today announced the signing of a strategic Master Supply Agreement with Cellectar Biosciences, Inc. (NASDAQ: CLRB) under which Cellectar will acquire and integrate NorthStar’s n.c.a. Ac-225 into Cellectar’s proprietary Phospholipid Ethers (PLE) delivery platform to expand the platform’s capability to produce a diverse range of radiotherapeutic molecules.

NorthStar is a global innovator in the development, production, and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging. Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer.

“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.”

“Cellectar’s novel TAT compounds, including CLR 121225 and others, have demonstrated their potential in devastating diseases like pancreatic cancer, that for too long have had no highly effective treatments,” said Frank Scholz, president and CEO of NorthStar. “Recent years have seen an increased interest in alpha-emitting radiotherapies like Cellectar’s compound which is expected to enter a Phase 1 first-in-human study next year,” he continued, “but developments have been hampered by the relative scarcity of Ac-225 supply. At 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.“

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241121427542/en/

For NorthStar Medical Radioisotopes, LLC

Corporate:

Alison Hess

Vice President, Chief of Staff

608-295-9806

ahess@northstarnm.com

Investor Relations:

Paul Estrem

Executive Vice President and Chief Financial Officer

608-987-8318

pestrem@northstarnm.com

Source: NorthStar Medical Radioisotopes, LLC

FAQ

What is the purpose of NorthStar's supply agreement with Cellectar Biosciences (CLRB)?

NorthStar will provide non-carrier added actinium-225 (n.c.a Ac-225) to Cellectar for use in its radiotherapeutic development programs, including CLR 121225.

When will Cellectar (CLRB) begin Phase 1 trials for CLR 121225?

Cellectar plans to begin Phase 1 clinical trials for CLR 121225 in pancreatic cancer in 2025.

What types of cancers has Cellectar's (CLRB) CLR 121225 shown promise in treating?

CLR 121225 has demonstrated promising preclinical results in pancreatic cancer, triple negative breast cancer, and other solid tumors.