Cellectar Biosciences, Inc. (NASDAQ: CLRB) announced positive topline results from its Phase 2 CLOVER-WaM pivotal study evaluating iopofosine I 131 for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia (WM). The company is preparing to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval. These results mark a significant step forward for patients with WM, a rare form of non-Hodgkin's lymphoma, who have limited treatment options after relapse.
CLOVER-WaM Study Results
The CLOVER-WaM study is an international, multi-center, open-label Phase 2 trial assessing the efficacy and safety of iopofosine I 131 in previously treated patients with WM. The study's positive results will be presented in an oral session at the 66th Annual American Society of Hematology (ASH) Meeting and Exposition. The abstract, titled "Iopofosine I 131 in Previously Treated Patients with Waldenström Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM™)," highlights the potential of iopofosine I 131 as a targeted radiotherapeutic for WM.
Iopofosine I 131: A Potential First-in-Class Radiotherapeutic
Iopofosine I 131 is Cellectar's lead asset, a small-molecule Phospholipid Drug Conjugate (PDC) designed for targeted delivery of iodine-131 (radioisotope) to cancer cells. The PDC platform aims to improve efficacy and reduce off-target effects, potentially leading to better safety profiles compared to traditional cancer treatments. The company believes iopofosine I 131 could be a first-in-class therapeutic option for WM patients.
Commercialization and Financial Update
Cellectar has been actively preparing for the potential commercialization of iopofosine I 131, including partnering with key national and regional community cancer networks to understand the WM disease landscape. The company has also established a collaboration with the City of Hope Cancer Center to evaluate iopofosine I 131 in mycosis fungoides, a cutaneous T-cell lymphoma.
In addition to clinical advancements, Cellectar has strengthened its supply network through agreements with SpectronRx for commercial finished product supply and Northstar Medical Radioisotopes for alpha-emitting actinium 225 isotope supply. The company also raised $19.4 million through warrant exercises, with the potential to raise an additional $73.3 million, to support commercialization plans and future clinical development.
Financial Position
As of September 30, 2024, Cellectar had $34.3 million in cash and cash equivalents. The company believes its current cash balance is sufficient to fund basic budgeted operations into the second quarter of 2025.
