Cellectar Biosciences will highlight strategic initiatives for 2025 at the upcoming Biotech Showcase during the JP Morgan Healthcare conference
An oral presentation presented at ASH 2024 showed that jopofosine I 131 achieved an 83.6% ORR and exceeded the primary and secondary efficacy endpoints in the phase 2 CLOVER-WaM study for relapsed/refractory Waldenstrom’s macroglobulinemia
Plans to advance Iopofosine I 131 internally, through strategic partnerships and other approaches; Completion of the confirmatory study and accelerated US FDA and EMA main marketing approval pathway
Advancement of radiotherapeutic agents including alpha- and snail-emitting radioconjugates in phase 1/2a solid tumor research
FLORHAM PARK, NJ, Jan. 12, 2025 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: NASDAQ: ), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces plans to highlighting the company’s strategic initiatives for 2025 at the Biotech Showcase taking place January 13-15, 2025 in San Francisco during 43rd JP Morgan Healthcare Annual Conference. James Caruso, president and chief executive officer of Cellectar, will present a corporate update on Tuesday, January 14, 2025, at 11:30 a.m. PT.
Iopofosine I 131 (iopofosine) is a potentially first-in-class, novel cancer targeting agent using a phospholipid ether as a radioconjugate monotherapy. Results from the CLOVER-WaM study (NCT02952508) showed 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 agreed primary endpoint of 20% MRR. These data were presented during the 66th Annual Conference of the American Society of Hematology in December 2024 by Sikander Ailawadhi, Ph.D. med., professor of medicine, Mayo Clinic.
We remain committed to bringing jopofosine to patients with WM, who have limited treatment options for this incurable disease, said James Caruso, president and CEO of Cellectar. We believe that our ongoing communication with the US Food and Drug Administration (FDA) indicates that there is a path forward for conditional approval for the US market as part of the accelerated approval process. This is consistent with our understanding of the feedback provided by the European Medicines Agency for the conditional authorization for the EU market and we are aligning the recommendations of both agencies for the global approval strategy.
The company expects the confirmatory study to be a comparative, randomized controlled trial with 40-60 patients per arm and full patient enrollment expected within 18 months of the first patient enrolled in the study. The company anticipates FDA compliance in the first half of 2025. With the current cash line extending into the fourth quarter of 2025, the company is evaluating different approaches to bring iopofosine to patients.
Mr. Caruso continued, We believe iopofosine represents a compelling partnership opportunity for many reasons, including the results observed in our clinical studies. The commercial work we have conducted at WM provides strong evidence that jopofosine possesses a significant market opportunity based on patient outcomes, appropriate fixed dosing, global distribution of the finished drug, and drug-drug pricing. Cellectar’s goal to bring life-saving radioconjugates such as jopofosine, CLR 121225 and CLR 121125 to patients remains steadfast, and we look forward to advancing our goals through 2025.
In addition to jopofosine, the company is focused on developing its Phospholipid Drug Conjugate™ (PDC) radioconjugate 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 is well tolerated in multiple animal models of solid tumors, including pancreatic, colon, and breast cancer. It also showed excellent biodistribution and tumor uptake. In animal models of pancreatic adenocarcinoma, the single lowest dose tested allowed tumor growth and the highest dose allowed tumor volume to decrease. The company plans to submit an investigational new drug (IND) application in the first quarter of 2025.
Cellectar’s flagship (iodine-125)-emitting PRC, CLR 121125, has demonstrated tolerability and activity in multiple animal models including triple-negative breast cancer. Auger emitters provide the highest precision in targeted radiotherapy since the emissions travel only a few nanometers, thus requiring the isotope to be delivered intracellularly. The company’s new PDC platform uniquely provides the targeted delivery required. CLR121125 has received IND approval and a phase 1b/2a dose-finding study in triple-negative breast cancer is planned.
The company is estimating the timing of study initiation for CLR 121225 and CLR 121125.
Biotechnology showcase
Live broadcast and replay of the presentation of Mr. Carusa at the Biotech Showcase will be available on the company’s Investor Relations website.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of proprietary cancer drugs, both independently and through collaborative research and development. The company’s primary goal is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop next-generation treatments that target cancer cells, providing improved efficacy and better safety as a result of fewer side effects.
The company’s product pipeline includes lead, iopofosine I 131, a PDC designed for targeted delivery of iodine-131 (a radioisotope), CLR 121225, an actinium-225-based program targeting several solid tumors with significant unmet need, such as pancreatic cancer, CLR 121125, a targeted program that emits iodine-125 Auger in other solid tumors, such as triple negative breast, lung and colorectal tumors, proprietary preclinical PDC chemotherapy programs and multiple partner PDC assets.
In addition, jopofosine I 131 was studied in phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the phase 1b CLOVER-2 study, targeting pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a pediatric review voucher from the FDA upon approval. The FDA has also granted iopofosine I 131 six Orphan Drug, four Orphan Pediatric and two Fast Track designations for various cancer indications.
For more information, visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn and Facebook (NASDAQ:).
Forward-Looking Statement Disclaimer
This press release contains forward-looking statements. You may recognize these statements by our use of words such as “may,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate,” “continue,” “plan” or their negatives or relatives. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that could cause actual future experiences and results to differ materially from the statements made. These statements are based on our current beliefs and expectations regarding such future outcomes. Drug discovery and development involves a high degree of risk. Factors that could cause such a material difference include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to disruptions at our sole supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, their successful preclinical development, enrollment patients and completion of clinical studies, FDA and EMA review processes and other government regulations, our ability to obtain regulatory exclusivity, availability of priority review vouchers, our ability to successfully develop and we commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party fees. A full description of the risks and uncertainties associated with our business is contained in our periodic reports filed with the Securities and Exchange Commission, including our Form 10-K/A for the year ended December 31, 2023 and our Form 10-Q for the quarter ended is September 30, 2024. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update such forward-looking statements.
Contact for investors:
Anne Marie Fields
Accuracy of AQ
212-362-1200
annemarie.fields@precisionaq.com
