On January 12, 2025 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, reported plans to highlight the Company’s 2025 strategic initiatives at Biotech Showcase, taking place January 13-15, 2025 in San Francisco during the 43rd Annual JP Morgan Healthcare Conference (Press release, Cellectar Biosciences, JAN 12, 2025, View Source [SID1234649702]). James Caruso, president and CEO of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 am Pacific Time.
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Iopofosine I 131 (iopofosine) is a potential first-in-class, novel cancer targeting agent utilizing a phospholipid ether as a radioconjugate monotherapy. The CLOVER-WaM study (NCT02952508) results demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% (95% CI, 0.42 to 0.67), which exceeded the agreed-upon primary endpoint of a 20% MRR. These data were presented as a podium presentation during the 66th Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Conference in December 2024 by Sikander Ailawadhi, M.D., Professor of Medicine, Mayo Clinic.
"We remain committed to bringing iopofosine to WM patients, who have limited treatment options for this incurable disease," said James Caruso, president and CEO of Cellectar. "We believe our ongoing communications with the U.S. Food and Drug Administration (FDA) indicate there is a path forward for a conditional U.S. market approval as part of the accelerated approval process. This aligns with our understanding of feedback provided by the European Medicines Agency for conditional EU market authorization, and we are 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 and full patient enrollment projected within 18 months of the first patient admitted to the study. The Company anticipates alignment with the FDA in the first half of 2025. 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.
Mr. Caruso continued, "We believe iopofosine represents a compelling partnership opportunity for many reasons including the results observed from our clinical studies. The commercial work we conducted in WM provides strong evidence that iopofosine possesses a substantial market opportunity based upon patient outcomes, convenient fixed dosing, off-the-shelf global distribution, and orphan pricing. Cellectar’s goal to bring lifesaving radioconjugates, such as iopofosine, CLR 121225, and CLR 121125, to patients remains steadfast and we look forward to advancing our objectives throughout 2025."
Beyond iopofosine, the Company is focused on the development of its radioconjugate Phospholipid Drug ConjugateTM (PDC) programs, also known as phospholipid radioconjugates or PRCs. CLR 121225 is Cellectar’s lead alpha-emitting actinium-225 radioconjugate PRC. It 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.
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, therefore it is necessary for the isotope to be delivered intracellularly. 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.
The Company is evaluating the timing of study initiation for both CLR 121225 and CLR 121125.
Biotech Showcase
A live webcast and a replay of Mr. Caruso’s presentation at Biotech Showcase will be available on the Company’s investor relations website.