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Cellectar Biosciences to Report Third Quarter Financial Results and Host a Conference Call on Thursday, November 13, 2025
Globenewswire· 2025-11-06 13:05
Core Insights - Cellectar Biosciences, Inc. will report its financial results for Q3 2025 and provide a corporate update on November 13, 2025, at 8:30 a.m. Eastern Time [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical radiopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [3] Product Pipeline - The company's lead assets include: - **Iopofosine I 131**: A PDC for targeted delivery of iodine-131, aimed at treating hematologic and solid tumors, including Waldenstrom's macroglobulinemia and pediatric high-grade gliomas - **CLR 121125**: An iodine-125 Auger-emitting program targeting solid tumors such as triple-negative breast, lung, and colorectal cancers - **CLR 121225**: An actinium-225 based program targeting solid tumors with significant unmet needs, including pancreatic cancer - Additional proprietary preclinical PDC chemotherapeutic programs and partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has undergone Phase 2b trials for various cancers and is part of the CLOVER-2 Phase 1b study for pediatric patients with high-grade gliomas. The FDA has granted multiple designations for this drug, including Breakthrough Therapy and Orphan Drug status [5]
Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma
Globenewswire· 2025-10-27 12:30
Core Insights - Cellectar Biosciences announced that the FDA granted Rare Pediatric Drug Designation for iopofosine I 131, a treatment for inoperable relapsed or refractory pediatric high-grade glioma, highlighting its potential to address a critical need in pediatric oncology [1][3][15] - Interim results from the CLOVER-2 Phase 1b trial showed significant improvements in progression-free survival (PFS) and overall survival (OS) for patients treated with iopofosine I 131, indicating its promise as a novel therapeutic option [5][6][12] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ delivery platform [13][14] - The company aims to provide targeted cancer therapies that improve efficacy and safety, with iopofosine I 131 being a key asset in its pipeline [14] Clinical Study Insights - The CLOVER-2 trial involves children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas, assessing the safety and tolerability of iopofosine I 131 [12] - Interim data revealed that patients receiving a minimum of 55 mCi total administered dose experienced an average PFS of 5.4 months and OS of 8.6 months, with some patients achieving even longer survival rates [6][9] Safety Profile - Iopofosine I 131 demonstrated a favorable safety profile, with no significant cardiovascular, renal, or liver toxicities reported, and manageable hematologic adverse events [9][10] - The treatment's selective targeting resulted in clinically negligible off-target effects, reinforcing its potential as a safe therapeutic option for pediatric patients [9] Case Studies - Two case studies presented in the trial showed promising results: a 25-year-old male with a target lesion reduction of over 50% and a PFS of 10.9 months, and a 15-year-old female with a target lesion reduction and a PFS of 11.2 months [7][8]
Cellectar Biosciences Presented Promising Preclinical Data in Poster Presentation at the American Association for Cancer Research (AACR) Special Conference on Pancreatic Cancer Research
Globenewswire· 2025-10-14 12:30
Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 121225 (CLR 225), an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential for treating pancreatic ductal adenocarcinoma (PDAC) [1][2] - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 clinical trials [1][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, leveraging its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [6][7] - The company's product pipeline includes CLR 121225 targeting pancreatic cancer, iopofosine I 131 for hematologic and solid tumors, and other preclinical PDC chemotherapeutic programs [7] Preclinical Data Highlights - CLR 225 demonstrated robust anti-tumor activity and selective biodistribution in three pancreatic cancer xenograft models, showing meaningful tumor growth inhibition and potential survival benefits [2][3] - The compound was well-tolerated across all dosing levels, with no adverse effects noted in body weight or animal health [2] Mechanism of Action - CLR 225 targets lipid rafts to deliver treatment directly to tumor cells, addressing the dense extracellular matrix characteristic of pancreatic cancer, which is a significant barrier to effective treatment [2][5] Market Context - PDAC is a severe disease with less than 10% survival after five years, accounting for approximately 90% of the 67,500 new pancreatic cancer cases in the U.S. annually [4]
Cellectar Biosciences, Inc. Enters Into Agreements to Raise $5.8 Million
Globenewswire· 2025-10-07 12:30
Core Viewpoint - Cellectar Biosciences, Inc. has entered into an agreement with institutional investors to exercise existing warrants, generating approximately $5.8 million in gross proceeds for the company [1][2]. Group 1: Financial Details - The company will receive gross proceeds of approximately $5.8 million from the exercise of 1,048,094 existing warrants at an exercise price of $5.25 each [1][2]. - The new warrants issued will include 1,048,094 Series I and 1,048,094 Series II warrants, with an exercise price of $6.00 per share [3]. - The Series I warrants have a five-year term, while the Series II warrants have an 18-month term from the date of initial exercise [3]. Group 2: Use of Proceeds - The net proceeds from this offering will be utilized for working capital, general corporate purposes, and specifically for the Phase 1b clinical study of CLR 121125 in triple-negative breast cancer [4]. Group 3: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate™ (PDC) delivery platform [7]. - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors and designed to improve efficacy and safety [8].
Cellectar and Evestia Clinical Announce Partnership to Support Auger-Emitting Radiopharmaceutical Clinical Trial in Triple-Negative Breast Cancer (TNBC)
Globenewswire· 2025-09-24 12:30
Core Insights - Cellectar Biosciences intends to initiate a Phase 1b clinical trial for CLR 125, targeting triple-negative breast cancer (TNBC), at the Mayo Clinic in the fourth quarter of 2025 [1][3] - Evestia Clinical will provide comprehensive CRO services for this trial, leveraging its expanded capabilities following a merger with Atlantic Research Group [2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [7][8] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [8][9] Clinical Trial Details - The Phase 1b trial will evaluate CLR 125, an iodine-125 Auger-emitting drug candidate, specifically for TNBC, which is known for its aggressive nature and limited treatment options [1][4] - The trial will be led by Pooja Advani, MBBS, MD, at a Mayo Clinic Network site, ensuring high-quality clinical oversight [3] Industry Context - TNBC accounts for approximately 12% of breast cancer diagnoses in the U.S., with a high recurrence rate of about 25% (40,540 cases) after standard treatments [4] - There is a critical need for innovative therapies in TNBC due to its poor prognosis and rapid progression [4] Evestia Clinical Overview - Evestia Clinical is a global specialist CRO that partners with biotech companies to accelerate the development of life-saving therapies, offering a full suite of customized clinical development services [5][6] - The merger with Atlantic Research Group has enhanced Evestia's oncology expertise and expanded its U.S. presence [2][3]
Cellectar Biosciences to Participate in Multiple Upcoming Medical Meetings and Industry Conferences in September
Globenewswire· 2025-09-05 12:45
Core Insights - Cellectar Biosciences, Inc. is actively participating in multiple medical meetings and industry conferences in September 2025, showcasing its commitment to advancing cancer treatment [1][2][3][4][5][6]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, both independently and through collaborations [7]. - The company aims to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to create next-generation cancer cell-targeting treatments, enhancing efficacy and safety by reducing off-target effects [8]. Product Pipeline - The company's lead assets include: - Iopofosine I 131, a PDC designed for targeted delivery of iodine-131, currently studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric high-grade gliomas [9][10]. - CLR 121225, an actinium-225 based program targeting solid tumors with significant unmet needs, such as pancreatic cancer [9]. - CLR 121125, an iodine-125 Auger-emitting program aimed at other solid tumors, including triple-negative breast, lung, and colorectal cancers [9]. Regulatory Designations - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications, indicating its potential significance in the oncology market [10].
Cellectar Biosciences to Present Data in Oral Session and Panel Discussions at the American Association for Cancer Research Special Conference on Discovery and Innovation in Pediatric Cancer
Globenewswire· 2025-08-27 12:05
Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation at the AACR Special Conference on Pediatric Cancer, focusing on interim data from the CLOVER-2 Phase 1b study of iopofosine I 131 in pediatric high-grade glioma patients [1][2] Group 1: Presentation Details - The oral presentation titled "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment" is scheduled for September 26, 2025, at 2:50 pm Eastern time [3] - Jarrod Longcor, the chief operating officer of Cellectar, will present the findings during the plenary session [3] Group 2: Background on Pediatric High-Grade Gliomas - Pediatric high-grade gliomas are aggressive tumors affecting the brain and central nervous system, with poor median progression-free survival (PFS) of approximately 2.25 months and overall survival (OS) of about 5.6 months for relapsed cases [4] Group 3: CLOVER-2 Trial Overview - The ongoing Phase 1b trial of iopofosine I 131 includes children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas across multiple sites in the U.S. and Canada [5] - The study evaluates the safety and tolerability of two dosing cohorts, with one cohort receiving 20 mCi/m² and the other 10 mCi/m², both separated by 14 days [5] - The trial aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction [5] Group 4: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [6] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [7][8] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [9]
Cellectar Biosciences to Report Second Quarter Financial Results and Host a Conference Call on Thursday, August 14, 2025
Globenewswire· 2025-08-07 12:05
Core Insights - Cellectar Biosciences, Inc. is set to report its financial results for Q2 2025 and provide a corporate update on August 14, 2025, at 8:30 a.m. Eastern Time [1] - The company focuses on the discovery, development, and commercialization of cancer treatment drugs, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company dedicated to developing proprietary drugs for cancer treatment, both independently and through collaborations [3] - The company's primary goal is to enhance cancer treatment efficacy and safety by minimizing off-target effects through its PDC delivery platform [3] Product Pipeline - The product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, designed for targeted delivery of iodine-131 [4] - CLR 121225 targets solid tumors with high unmet needs, such as pancreatic cancer, using actinium-225 [4] - CLR 121125 focuses on iodine-125 Auger-emitting treatments for various solid tumors, including triple-negative breast cancer, lung cancer, and colorectal cancer [4] - The company also has proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets [4] Clinical Trials and Designations - Iopofosine I 131 has been evaluated in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and in a Phase 1b study for pediatric patients with high-grade gliomas [5] - The FDA has granted iopofosine I 131 six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations for various cancer indications [5]
Cellectar Biosciences Enters into Common Stock Agreements to Raise $2.5 Million Priced at Market Under Nasdaq Rules
Globenewswire· 2025-06-05 13:00
Core Viewpoint - Cellectar Biosciences, Inc. has entered into definitive agreements to raise $2.5 million through the sale of common stock, with the closing expected around June 6, 2025, pending customary conditions [1] Group 1: Financial Details - The company will raise $2.5 million from the sale of shares priced at-market for Nasdaq purposes [1] - The agreements include the immediate exercise of existing warrants for a total of 8,301,322 shares at a reduced exercise price of $0.3041 per share, expected to generate approximately $2.5 million in gross proceeds [3] - The net proceeds will be used for general corporate purposes, including working capital and operating expenses [3] Group 2: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [5] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various cancers with significant unmet needs [6] Group 3: Product Development and Designations - Iopofosine I 131 has received Breakthrough Therapy Designation from the FDA and has been studied in Phase 2b trials for multiple myeloma and CNS lymphoma [7] - The product has also received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [7]