Core Insights - Cellectar Biosciences presented positive preclinical data for CLR 225, an actinium-based radio conjugate, at the AACR Special Conference on Pancreatic Cancer Research, indicating its potential to inhibit tumor growth and improve survival in pancreatic cancer models [1][2] 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] Product Development - CLR 225 has completed IND-enabling studies and is positioned to advance into Phase 1 studies, demonstrating robust anti-tumor activity and selective biodistribution in preclinical models [1][3] - The studies involved three pancreatic cancer xenograft models (PANC-1, MIA PaCa-2, and BxPC-3), showing meaningful inhibition of tumor growth and potential survival benefits [2][3] 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 - Pancreatic ductal adenocarcinoma (PDAC) is a severe disease with less than 10% five-year survival rate, accounting for approximately 90% of pancreatic cancer cases in the U.S. [4]

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]

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].

Core Viewpoint - Cellectar Biosciences is preparing to submit a Conditional Marketing Authorization (CMA) application for iopofosine I 131 as a treatment for refractory Waldenstrom macroglobulinemia (WM), with potential European approval and commercial launch expected in 2027 [1][4]. Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing drugs for cancer treatment, utilizing its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform [14][15]. Product Details - Iopofosine I 131 is a novel cancer-targeting agent designed for post-BTKi refractory WM patients, having received PRIME designation from the EMA for patients who have undergone at least two prior lines of therapy [2][11]. - The drug has demonstrated an overall response rate (ORR) of 83.6% and a major response rate (MRR) of 58.2% in the CLOVER WaM Phase 2 study [4][6]. Regulatory Pathway - The decision to file for CMA follows advice from the Scientific Advice Working Party (SAWP) of the EMA, which indicated that the data supports the eligibility for CMA submission for the specified patient population [3][8]. - CMA allows for earlier access to medicines addressing unmet medical needs, permitting approval based on less comprehensive clinical data [8]. Market Opportunity - There is a significant unmet medical need for WM treatment in Europe, affecting an estimated 35,000 to 45,000 patients [3][12]. - The company believes that iopofosine I 131 presents a substantial market opportunity due to its compelling patient outcomes and regulatory designations [5][12]. Future Plans - The company plans to pursue worldwide approval, including a New Drug Application (NDA) with the U.S. FDA under an accelerated approval pathway, contingent upon obtaining additional funding for a confirmatory study [4][6]. - The U.S. NDA will be supported by data from the Phase 2b CLOVER WaM clinical trial, which includes FDA-requested follow-up results [6][7].

Core Insights - Cellectar Biosciences announced promising interim results from the CLOVER-2 Phase 1b clinical study of iopofosine I 131, showing extended progression-free survival (PFS) and overall survival (OS) in pediatric patients with relapsed or refractory high-grade gliomas [1][3][4] Study Details - The CLOVER-2 trial involves children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas, focusing on safety, tolerability, and therapeutic activity of iopofosine I 131 [10] - Patients in the study experienced an average PFS of 5.4 months and OS of 8.6 months, with those receiving additional dosing cycles showing even better outcomes [4][7] Patient Outcomes - Two case studies highlighted significant tumor volume reduction and extended survival in patients treated with iopofosine I 131, with one patient achieving a PFS of 10.9 months and ongoing survival exceeding 18 months [5][6] - The safety profile of iopofosine I 131 was consistent with previous data, showing no severe toxicities and manageable hematologic adverse events [7] Regulatory Designations - The FDA has granted iopofosine I 131 several designations, including Rare Pediatric Drug and Orphan Drug status, indicating its potential as a significant treatment option for pediatric high-grade gliomas [2][13] Company Overview - Cellectar Biosciences focuses on developing proprietary drugs for cancer treatment, leveraging its Phospholipid Drug Conjugate delivery platform to enhance efficacy and safety [11][12]

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]

Core Viewpoint - Cellectar Biosciences and ITM Isotope Technologies Munich have entered a supply agreement for Actinium-225 to support the clinical development of Cellectar's CLR 121225, a novel radiopharmaceutical for treating solid tumors, including pancreatic cancer [1][2][3] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate delivery platform [5] - ITM Isotope Technologies Munich SE specializes in radiopharmaceuticals and aims to provide innovative therapeutics and diagnostics for hard-to-treat tumors, leveraging over two decades of expertise in medical isotope manufacturing [9] Product Pipeline - Cellectar's product pipeline includes iopofosine I 131, which has received Breakthrough Therapy Designation from the FDA, and CLR 121225, targeting solid tumors with significant unmet needs, such as pancreatic cancer [6][7] - CLR 121225 is designed to selectively target and eradicate cancer cells using a proprietary PLE delivery platform [2][6] Strategic Partnership - The agreement between Cellectar and ITM ensures a continuous, high-quality supply of Actinium-225, which is crucial for advancing Cellectar's pipeline candidates and exploring the benefits of targeted alpha therapy for cancer patients [3][4] - ITM's joint venture, Actineer, is dedicated to advancing Ac-225 technologies and aims to meet the growing global demand for this critical isotope [10] Market Context - The scarcity of high-quality Ac-225 has hindered the development of Ac-225 based programs, prompting Cellectar to establish a network of suppliers to ensure sufficient access [3][4] - The partnership reflects a strategic commitment to enhancing global access to radiopharmaceuticals and improving patient outcomes through innovative therapies [4]

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].

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for a poster presentation at the AACR Special Conference on Pancreatic Cancer Research, highlighting preclinical data for CLR 121225, an actinium-based radio conjugate for treating hypoxic pancreatic ductal adenocarcinoma [1][2] Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on discovering and developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform to enhance efficacy and safety [3][4] Product Pipeline - The company's product pipeline includes lead assets such as iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs, including pancreatic cancer and triple-negative breast cancer [4][5] Clinical Trials and Designations - Iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma and CNS lymphoma, and is eligible for a Pediatric Review Voucher from the FDA upon approval, having received multiple designations for various cancer indications [5]

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]