Welcome to our dedicated page for Cellectar Biosciences news (Ticker: CLRB), a resource for investors and traders seeking the latest updates and insights on Cellectar Biosciences stock.
About Cellectar Biosciences Inc.
Cellectar Biosciences Inc. (NASDAQ: CLRB) is a late-stage clinical biopharmaceutical company dedicated to advancing the treatment of cancer through its proprietary Phospholipid Drug Conjugate™ (PDC) platform. This innovative technology is designed to deliver therapeutic payloads directly to cancer cells, offering enhanced efficacy and reduced off-target effects. By leveraging its PDC platform, the company aims to address significant unmet medical needs in oncology while improving patient outcomes.
Core Technology: The PDC Platform
Cellectar’s PDC platform is based on proprietary phospholipid ether analogs, which demonstrate highly selective uptake and retention in cancer cells. This precision-targeting capability enables the development of therapies that minimize damage to healthy tissue, making it a promising approach for both therapeutic and diagnostic applications. The platform supports the delivery of various oncologic payloads, including radioisotopes, chemotherapeutics, and other therapeutic agents.
Pipeline and Lead Product Candidates
The company’s product pipeline includes a diverse range of assets designed to target hematologic malignancies and solid tumors:
- Iopofosine I 131: A small-molecule PDC utilizing iodine-131, a cytotoxic radioisotope, to target and destroy cancer cells. This lead asset is under evaluation in clinical trials for multiple indications, including Waldenstrom’s macroglobulinemia (WM), multiple myeloma, and central nervous system lymphoma. It has received Orphan Drug and Fast Track Designations from the U.S. FDA for various cancer indications.
- CLR 121225: An actinium-225-based alpha-emitting radioconjugate targeting solid tumors such as pancreatic and triple-negative breast cancers. This program aims to leverage the precision of alpha emitters for enhanced efficacy in difficult-to-treat cancers.
- CLR 121125: An iodine-125 Auger-emitting radioconjugate with applications in triple-negative breast, lung, and colorectal cancers. Auger emitters offer unparalleled precision, delivering therapeutic effects at the subcellular level.
Strategic Focus and Market Position
Cellectar’s strategy combines internal drug development with external collaborations to maximize the potential of its PDC platform. By partnering with other biopharmaceutical companies, Cellectar expands the applicability of its technology while diversifying its revenue streams. The company’s focus on radiopharmaceuticals positions it within a niche but growing segment of the oncology market, where demand for targeted therapies is increasing.
Industry Challenges and Opportunities
Operating in the competitive oncology sector, Cellectar faces challenges such as regulatory approvals, supply chain complexities for rare isotopes, and significant capital requirements for clinical development. However, its proprietary platform, coupled with a robust pipeline and strategic collaborations, provides a strong foundation for addressing these challenges. The company’s focus on unmet medical needs and orphan drug markets further enhances its growth potential.
Commitment to Innovation
With a mission to revolutionize cancer treatment, Cellectar continues to advance its pipeline and explore new applications for its PDC platform. Its dedication to innovation, combined with a strategic approach to development and commercialization, underscores its potential to make a lasting impact in oncology.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company specializing in cancer treatment drug development, has scheduled its full year 2024 financial results announcement and corporate update for March 13, 2025, at 8:30 a.m. Eastern Time. The company will make a replay of the conference call available through their Investor Relations website's Events section.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company specializing in cancer treatment drug development, has announced its participation in the upcoming Oppenheimer 35th Annual Healthcare Life Sciences Conference. The company's management team will deliver a corporate presentation on Wednesday, February 12, 2025, at 12:00 PM Eastern Time.
The conference will be held virtually, and interested parties can access the presentation through a provided webcast link. Following the live presentation, a replay will be made available in the Events section of Cellectar's investor relations website.
Cellectar Biosciences (NASDAQ: CLRB) announced its 2025 strategic initiatives, highlighting significant progress with its cancer treatment drug Iopofosine I 131. The company reported impressive Phase 2 CLOVER-WaM study results, achieving an 83.6% overall response rate and exceeding primary endpoints in treating Waldenstrom's Macroglobulinemia.
The company is finalizing its confirmatory study for FDA accelerated approval and EMA authorization, expecting to enroll 40-60 patients per arm with completion projected within 18 months. Cellectar's cash runway extends into Q4 2025, and they're exploring various approaches to commercialize Iopofosine.
Additionally, Cellectar is advancing two other radiotherapeutic assets: CLR 121225, an alpha-emitting radioconjugate showing promising results in solid tumor models, with IND filing planned for Q1 2025, and CLR 121125, an Auger-emitting PRC with IND clearance for triple-negative breast cancer trials.
Cellectar Biosciences (NASDAQ: CLRB) announces strategic changes, including pursuing options for iopofosine I 131 development following FDA communications regarding confirmatory study requirements. The company will shift focus to advancing its alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies.
The FDA indicated that accelerated approval would require major response rate data from CLOVER-WaM study and enrollment in a randomized controlled confirmatory study for progression-free survival data. The company plans to file Investigational New Drug applications for CLR-121225 and CLR-121125 in first half of 2025.
As part of restructuring, Cellectar will reduce headcount by approximately 60% by end of Q4 2024, extending cash runway into Q3 2025.
NorthStar Medical Radioisotopes has signed a Master Supply Agreement with Cellectar Biosciences (NASDAQ: CLRB) to provide non-carrier added actinium-225 (n.c.a Ac-225) for Cellectar's radiotherapeutic development programs. The agreement will support Cellectar's CLR 121225, an actinium-labeled phospholipid ether (PLE) therapy, which has shown promising preclinical results in pancreatic, triple negative breast, and other solid tumors. The company plans to initiate Phase 1 clinical trials for CLR 121225 in pancreatic cancer in 2025. This partnership aims to address the scarcity of Ac-225 supply in radiotherapy development.
Cellectar Biosciences reported Q3 2024 financial results and corporate updates. The company reported positive results from Phase 2 CLOVER-WaM pivotal study for iopofosine I 131 in Waldenstrom's macroglobulinemia treatment. The company raised $19.4 million through warrant exercises with potential for additional $73.3 million. Cash position stood at $34.3 million as of September 30, 2024. R&D expenses decreased to $5.5 million from $7.0 million year-over-year, while G&A expenses increased to $7.8 million from $2.4 million. The company plans to file NDA submission in the coming months.
Cellectar Biosciences (NASDAQ: CLRB) has signed a strategic 10-year supply agreement with NorthStar Medical Radioisotopes for non-carrier-added Actinium-225 (Ac-225), a rare radioisotope essential for cancer treatment. The agreement supports Cellectar's CLR 121225 development program, which combines their Phospholipid Ether delivery platform with Ac-225 for solid tumor treatment.
The company plans to begin human clinical trials in 2025, following promising preclinical results in pancreatic, triple negative breast, and other solid tumors. This partnership addresses the critical challenge of Ac-225 scarcity in clinical development and commercialization, securing a reliable supply source for Cellectar's radiotherapeutic development strategy.
Cellectar Biosciences (NASDAQ: CLRB) and SpectronRx have signed a commercial supply agreement for manufacturing iopofosine I 131, a first-in-class cancer therapy. SpectronRx will produce the treatment at facilities in Indiana and Belgium, supporting Cellectar's planned 2025 commercialization. The drug has shown promising results in the CLOVER-WaM pivotal study for Waldenstrom's macroglobulinemia and is being evaluated in Phase 2 studies for multiple myeloma and CNS lymphoma, as well as a Phase 1b study for pediatric high-grade gliomas. The partnership strengthens Cellectar's global manufacturing network and distribution capabilities.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on cancer treatment, has scheduled its third quarter 2024 financial results announcement and corporate update for November 18, 2024, at 8:30 a.m. ET. The company will host a conference call accessible via toll-free number 1-800-717-1738 with conference ID 80659, and a webcast will be available. A replay of the call will be accessible through the company's investor relations website.
Cellectar Biosciences (NASDAQ: CLRB) announced that new data from their Phase 2 CLOVER-WaM study of iopofosine I 131 for Waldenstrom's macroglobulinemia (WM) treatment will be presented at ASH 2024. The study focuses on relapsed and refractory WM patients who received at least 2 prior therapies. The company plans to submit a New Drug Application to the FDA in the coming months and will seek priority review. Dr. Sikander Ailawadhi from Mayo Clinic will present the efficacy and safety results during an oral session on December 9, 2024, at the Marriott Marquis San Diego Marina.
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