Cellectar broadens global manufacturing network in preparation for potential commercialization of Iopofosine I 131 in 2025
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.