Cellectar and SpectronRx to Produce New Phospholipid Radioconjugate for Cancer Therapy

SpectronRx and Cellectar Biosciences have officially announced a commercial supply agreement for the production of Cellectar’s innovative cancer treatment, iopofosine I 131. The collaboration aims to strengthen Cellectar’s global manufacturing network in anticipation of the drug's potential market launch in 2025. SpectronRx, a prominent contract developer and manufacturer specializing in radiopharmaceuticals, will leverage its advanced facilities in Indiana and Belgium for the production of iopofosine I 131. This agreement is a strategic effort to ensure a robust and diverse global supply chain for the therapy which primarily targets advanced cancer patients.

James Caruso, the President and CEO of Cellectar, highlighted the significance of this partnership. He emphasized that SpectronRx’s expertise and well-placed facilities would facilitate the global distribution of iopofosine I 131, thereby enhancing the company’s manufacturing capabilities. This collaboration is a critical component of Cellectar’s broader commercial strategy to make the treatment accessible to patients suffering from advanced cancers, particularly those with Waldenstrom's macroglobulinemia (WM).

iopofosine I 131 has demonstrated significant efficacy, meeting both primary and secondary endpoints in the pivotal CLOVER-WaM study for relapsed or refractory WM. The drug is also undergoing Phase 2 evaluations for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. Moreover, it is being tested in a Phase 1b study, CLOVER-2, which focuses on pediatric patients with high-grade gliomas.

John Zehner, CEO of SpectronRx, expressed his excitement about the collaboration. He stated that the partnership aligns with SpectronRx’s mission to support innovative radiopharmaceutical companies in delivering transformative treatments worldwide. By combining SpectronRx’s advanced manufacturing capabilities with Cellectar’s groundbreaking therapies, both companies aim to address the unmet medical needs of cancer patients globally.

It is important to note that iopofosine I 131 is still an investigational drug and has not yet received approval. However, the FDA has granted it Orphan Drug and Fast Track Designations for various cancer indications, recognizing its potential benefit to patients with rare and serious conditions.

SpectronRx is a comprehensive developer and manufacturer of diagnostic and therapeutic radiopharmaceuticals. The company offers a wide range of services from initial drug conjugation and development to large-scale production and commercial distribution. With extensive facilities in Indiana, additional sites in Connecticut and Europe, and an expert team of radiochemists, radiopharmacists, scientists, and engineers, SpectronRx is well-equipped to expedite the development and market entry of new radiopharmaceuticals. The company serves 29 countries and has been inspected by both the EMA and FDA, demonstrating its capability to produce and supply various radioisotopes, including actinium-225.

Cellectar Biosciences is a late-stage clinical biopharmaceutical company dedicated to discovering, developing, and commercializing innovative cancer treatments. Utilizing its proprietary Phospholipid Drug Conjugate™ (PDC™) technology, Cellectar aims to create next-generation cancer therapies that offer targeted delivery and improved safety profiles. The company’s lead product, iopofosine I 131, is designed to deliver targeted radiotherapy to cancer cells, minimizing off-target effects and enhancing treatment efficacy. Cellectar’s product pipeline also includes preclinical PDC chemotherapeutic programs and multiple partnered PDC assets, underscoring its commitment to advancing cancer treatment.

In summary, the partnership between SpectronRx and Cellectar marks a significant step towards the potential commercialization of iopofosine I 131, promising to bring a novel cancer therapy to patients with urgent medical needs. The collaboration underscores both companies' commitment to developing and delivering innovative treatments that could significantly impact the lives of cancer patients worldwide.