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Strengthens Protection Around Broad Portfolio of Cancer-Targeting Drug Conjugates and Enabling Technologies
Provides Key Coverage Across Europe Ahead of Planned 3Q26 Filing for Conditional Marketing Approval with the European Medicines Agency (EMA) for Iopofosine I 131 as a Treatment for Waldenström Macroglobulinemia
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced a broad expansion of its global intellectual property (IP) estate, including newly issued patents across Europe, Asia-Pacific, the Middle East, and the Americas. These additions strengthen the company's protection around iopofosine I 131, its proprietary radiotherapeutic, as well as its broader portfolio, including CLR 125, the company's Auger-emitting radiopharmaceutical in development as a treatment for triple negative breast cancer.
"We are seeing meaningful and timely momentum across our global IP estate at a truly pivotal moment for the company," said James Caruso, president and CEO of Cellectar Biosciences. "Securing these patents in major international markets reinforces the uniqueness of our technology and provides critical intellectual property fortification. Following guidance from the EMA's Scientific Advice Working Party (SAWP) we are advancing our planned filing for conditional marketing authorization of iopofosine I 131 for Waldenström macroglobulinemia in Europe. This strengthened global protection is essential to our long-term commercial strategy—and, more importantly, it supports our commitment to delivering new, desperately needed therapeutic options to patients who continue to face limited treatment choices."
The expanded IP coverage spans multiple patent families critical to the company's therapeutic and platform strategies:
- Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging Cancer Stem Cells
- Covers iopofosine I 131 and CLR-125 for both therapeutic use and imaging/detection of primary tumors and cancer stem cells.
- Newly issued in Europe, China, Israel, Eurasia, and New Zealand.
- Fractionated Dosing of a Phospholipid Ether Analog for the Treatment of Cancer
- Covers proprietary iopofosine I 131 dosing regimens.
- Newly issued in Eurasia, Israel, Turkey, Mexico, and Canada.
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); CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal, and is currently being evaluated in a Phase 1b study for TNBC; CLR 121225 (CLR 225), an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer, 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 granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIME.
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.
Forward Looking Statements 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 September 30, 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.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
