Cellectar Biosciences: Radiotherapeutic Assets Poised for Growth in 2025

Cellectar Biosciences, Inc. (NASDAQ: CLRB) is set to highlight its strategic initiatives for 2025 at the upcoming Biotech Showcase during the JP Morgan Healthcare Conference. The company's focus on radiotherapeutic assets, including iopofosine I 131, CLR 121225, and CLR 121125, positions it well for growth and value creation in the coming year.

Iopofosine I 131, a potential first-in-class cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy, has demonstrated remarkable results in the Phase 2 CLOVER-WaM study for relapsed/refractory Waldenstrom's Macroglobulinemia (WM). The drug achieved an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2%, exceeding the agreed-upon primary endpoint of a 20% MRR. These impressive data were presented as a podium presentation during the 66th Annual American Society of Hematology Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic.

Cellectar Biosciences is committed to bringing iopofosine to WM patients, who have limited treatment options for this incurable disease. The company believes there is a path forward for conditional U.S. market approval as part of the accelerated approval process, aligning with feedback provided by the European Medicines Agency for conditional EU market authorization. Cellectar is harmonizing recommendations from both agencies for a global approval strategy.

The company expects the confirmatory study to be a comparator, randomized controlled study with 40-60 patients per arm, with full patient enrollment projected within 18 months of the first patient admitted to the study. Cellectar anticipates alignment with the FDA in the first half of 2025, which will help guide the confirmatory study design and timeline. With a current cash runway extending into the fourth quarter of 2025, the company is assessing a variety of approaches to bring iopofosine to patients, including internal development, strategic partnerships, and other options.

Beyond iopofosine, Cellectar Biosciences is focused on advancing its radioconjugate Phospholipid Drug Conjugate™ (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225, the company's lead alpha-emitting actinium-225 radioconjugate PRC, has demonstrated activity and has been well tolerated in multiple solid tumor animal models, including pancreatic, colorectal, and breast cancer. It has also shown excellent biodistribution and uptake into tumors. In animal models of pancreatic adenocarcinoma, the single lowest dose tested provided tumor stasis, and the highest dose provided tumor volume reduction. The Company plans to file an Investigational New Drug (IND) application in the first quarter of 2025, which will enable the initiation of Phase 1 clinical studies in solid tumor cancers.

Cellectar's lead Auger-emitting (iodine-125) PRC, CLR 121125, has demonstrated tolerability and activity in multiple animal models, including triple-negative breast cancer. Auger-emitters provide the greatest precision in targeted radiotherapy as the emissions only travel a few nanometers, making intracellular delivery necessary. The Company's novel PDC platform uniquely provides the required targeted delivery. CLR121125 has received IND clearance, and a Phase 1b/2a dose finding study in triple-negative breast cancer is planned.



Cellectar Biosciences' strategic initiatives for 2025 present a compelling opportunity for investors seeking exposure to the growing radiotherapeutic assets market. The company's focus on iopofosine I 131, CLR 121225, and CLR 121125 positions it well to capitalize on the market potential of these assets. As the company continues to advance its radioconjugate PDC programs, investors can expect to see further progress and value creation in the coming year.



In conclusion, Cellectar Biosciences' strategic initiatives for 2025, centered around its radiotherapeutic assets, present a promising opportunity for investors. The company's focus on iopofosine I 131, CLR 121225, and CLR 121125, along with its strong clinical data and market potential, positions it well for growth and value creation in the coming year. As the company continues to advance its radioconjugate PDC programs, investors can expect to see further progress and potential returns on their investments.