Cellectar Biosciences, Inc., a late-stage clinical biopharmaceutical company, has announced that new data from its open-label Phase 2 CLOVER-WaM study of iopofosine I 131 as a potential treatment for Waldenstrom’s macroglobulinemia (WM) will be highlighted in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition (ASH 2024). The meeting is scheduled to take place from December 7–10, 2024, in San Diego, California.
Iopofosine I 131, Cellectar’s lead product candidate, is a novel cancer targeting agent that utilizes a phospholipid ether as a radioconjugate. It is an investigational agent and has not been approved for use in any country for any indication. WM, a B-cell malignancy, remains incurable with available therapies, highlighting the urgent need for new treatments with novel mechanisms of action.
The CLOVER-WaM trial assessed the efficacy and safety of iopofosine I 131 in relapsed and refractory patients with WM who had received at least two prior therapies. The presentation at ASH 2024 will be delivered by Dr. Sikander Ailawadhi, a professor of medicine at the Mayo Clinic, and will cover the efficacy and safety results from this international, multicenter, open-label Phase 2 study.
James Caruso, president and CEO of Cellectar, expressed the company's honor in having the positive results from the CLOVER-WaM trial selected for oral presentation at ASH 2024. He emphasized the potential of iopofosine I 131 to establish itself as the standard-of-care for relapsed/refractory patients and mentioned plans to submit a New Drug Application with the U.S. Food and Drug Administration in the coming months, seeking priority review given the limited effective therapeutic alternatives available for WM patients.
Waldenstrom’s Macroglobulinemia is characterized by bone marrow infiltration with clonal lymphoplasmacytic cells that produce a monoclonal immunoglobulin M (IgM). With a prevalence of approximately 26,000 in the US and 1,500–1,900 new diagnoses annually, there is a significant unmet need for new FDA-approved treatments like Iopofosine I-131 that offer a novel mechanism of action, increased deep durable responses, and time-limited treatment, especially in heavily pretreated WM patients.
Cellectar Biosciences is focused on the discovery and development of proprietary drugs for the treatment of cancer, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC™) delivery platform to develop next-generation cancer cell-targeting treatments. The company’s product pipeline includes iopofosine I 131, among other preclinical PDC chemotherapeutic programs and partnered PDC assets.
