Cellectar Biosciences and SpectronRx Partner to Manufacture Novel Phospholipid Radioconjugate for the Treatment of Cancer
Rhea-AI Summary
Cellectar Biosciences (NASDAQ: CLRB) and SpectronRx have signed a commercial supply agreement for manufacturing iopofosine I 131, a first-in-class cancer therapy. SpectronRx will produce the treatment at facilities in Indiana and Belgium, supporting Cellectar's planned 2025 commercialization. The drug has shown promising results in the CLOVER-WaM pivotal study for Waldenstrom's macroglobulinemia and is being evaluated in Phase 2 studies for multiple myeloma and CNS lymphoma, as well as a Phase 1b study for pediatric high-grade gliomas. The partnership strengthens Cellectar's global manufacturing network and distribution capabilities.
Positive
- Strategic expansion of manufacturing capabilities through partnership with established radiopharmaceutical manufacturer
- Planned commercialization timeline set for 2025
- Drug has surpassed primary and secondary endpoints in CLOVER-WaM pivotal study
- Multiple ongoing clinical trials expanding potential market opportunities
Negative
- Product still requires FDA approval before commercialization
- Manufacturing dependent on third-party partnership
Insights
The commercial supply agreement with SpectronRx represents a significant strategic milestone in Cellectar's commercialization roadmap. The dual-facility manufacturing capability in Indiana and Belgium provides important geographic diversification and supply chain resilience, essential for global market distribution of radiopharmaceuticals with short half-lives.
The timing aligns with Cellectar's anticipated 2025 commercialization timeline for iopofosine I 131, particularly following strong clinical results in Waldenstrom's macroglobulinemia. The multi-sourced supply strategy reduces manufacturing risks and positions the company to meet potential market demand across multiple regions.
This partnership strengthens Cellectar's commercial preparedness ahead of their planned New Drug Application, while SpectronRx's expertise in radiopharmaceutical manufacturing adds credibility to their production capabilities.
The strategic placement of manufacturing facilities in both the US and Europe creates an optimal logistics framework for a radiopharmaceutical product. This is particularly important given the time-sensitive nature of radioactive materials and their specific handling requirements. The dual-location strategy will significantly reduce delivery times and transportation complexities while ensuring consistent supply to major markets.
The multi-sourced approach provides essential redundancy in the supply chain, protecting against potential disruptions and regulatory challenges in either region. This infrastructure investment signals strong confidence in the commercial prospects of iopofosine I 131 and demonstrates mature supply chain planning ahead of potential market approval.
Cellectar broadens global manufacturing network in preparation for potential commercialization of Iopofosine I 131 in 2025
INDIANAPOLIS and FLORHAM PARK, N.J., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpectronRx, a leading radiopharmaceutical contract developer and manufacturer, and 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, have signed a commercial supply agreement for the manufacture of Cellectar’s first-in-class cancer therapy, iopofosine I 131.
"We continue strengthening our supply network, ensuring patients with advanced cancers in need of novel therapeutic options gain access to what we believe is a best-in-class treatment for Waldenstrom's macroglobulinemia (WM). This partnership is part of our multi-sourced global supply strategy, which is key for Cellectar’s commercialization plans for iopofosine I 131," said James Caruso, president and CEO of Cellectar. "SpectronRx's expertise and strategically located facilities offer significant logistical benefits for global market distribution while expanding our manufacturing capabilities for iopofosine I 131.”
SpectronRx will utilize its state-of-the-art facilities in Indiana and Belgium to produce iopofosine I 131, a promising therapeutic that has shown impressive efficacy, surpassing primary and secondary endpoints in the CLOVER-WaM pivotal study for patients with relapsed or refractory WM with a planned New Drug Application submission in the near term. Furthermore, iopofosine I 131 is under evaluation in Phase 2 studies for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, alongside the CLOVER-2 Phase 1b study, targeting pediatric patients with high-grade gliomas.
John Zehner, CEO of SpectronRx, expressed enthusiasm about the collaboration, stating, "Our partnership with Cellectar aligns with our commitment to support innovative radiopharmaceutical developers in delivering life-changing treatments globally. By integrating our advanced manufacturing capabilities with Cellectar's groundbreaking therapies, we are poised to address the unmet needs of cancer patients worldwide."
Iopofosine I-131 is still investigational and not yet approved. The FDA has granted it Orphan Drug and Fast Track Designations for various cancer indications.
For more information about Cellectar, please visit Cellectar.com. To learn more about SpectronRx, visit SpectronRx.com.
About SpectronRx
SpectronRx is a diagnostic and therapeutic radiopharmaceutical developer and manufacturer with three distinct specialties: Radiopharmaceutical Contract Development (RCDMO), Radiopharmaceutical Contract Manufacturing (RCMO), and Isotope Production. The company performs all scales of development, from initial conjugations through scale-up and commercial distribution. It also has the capacity to run clinical trials. Additionally, SpectronRx's deep industry knowledge, technical prowess and state-of-the-art facilities enable the company to significantly condense the timeline for bringing new medicines to market, which has the dual benefit of saving lives and driving greater profitability for clients.
With a large staff of radiochemists, radiopharmacists, scientists and engineers, dozens of qualified clean rooms, and over 200,000 sq. ft. of production space in Indiana, with additional facilities in Danbury, Connecticut and Europe, SpectronRx now supplies therapeutic and diagnostic radiopharmaceuticals to 29 countries. The company has been EMA and FDA inspected and can produce and procure any currently used radioisotopes, including actinium-225. For more information visit SpectronRx.com, or follow the company on LinkedIn.
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 ConjugateTM (PDCTM) 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
When does Cellectar Biosciences (CLRB) plan to commercialize iopofosine I 131?
What is the manufacturing agreement between SpectronRx and Cellectar (CLRB)?
What clinical trials is iopofosine I 131 currently involved in for Cellectar (CLRB)?
