Cellectar Biosciences to present interim data on iopofosine I 131 for pediatric high-grade glioma at AACR conference.
Quiver AI Summary
Cellectar Biosciences, Inc. announced that an abstract concerning their treatment, iopofosine I 131, has been accepted for oral presentation at the AACR Special Conference on Pediatric Cancer, scheduled for September 25-28, 2025, in Boston. The presentation will focus on interim data from their Phase 1b study targeting inoperable relapsed or refractory pediatric high-grade glioma. Cellectar's COO, Jarrod Longcor, expressed pride in the selection and optimism about the initial findings from the CLOVER-2 trial, which aims to provide new treatment options for this aggressive cancer type. The study is evaluating the safety and efficacy of various dosing regimens of iopofosine I 131 in young patients. The company's drug development efforts include multiple innovative cancer therapies, supported by several FDA designations.
Potential Positives
- Acceptance of an abstract for an oral presentation at the prestigious AACR Special Conference, indicating recognition by peers in the field.
- Highlighting interim data from the CLOVER-2 trial for iopofosine I 131 in pediatric high-grade gliomas, showcasing the potential promise of this treatment.
- Potential eligibility for a Pediatric Review Voucher from the FDA upon approval, which could enhance the commercial prospects of iopofosine I 131.
- Demonstrates Cellectar's commitment to addressing significant unmet medical needs in pediatric oncology, potentially strengthening its position in the biopharmaceutical sector.
Potential Negatives
- The press release highlights a small sample size (n=14) in the CLOVER-2 trial, which could raise concerns about the reliability and generalizability of the interim data presented.
- The extremely poor median progression-free survival (PFS) and overall survival (OS) rates reported for pediatric high-grade glioma (approximately 2.25 months and 5.6 months, respectively) may reflect poorly on the effectiveness of treatments currently being explored, potentially impacting investor confidence.
- The mention of known and unknown risks and uncertainties associated with drug discovery and development in the forward-looking statements emphasizes a high degree of risk that could deter potential investors or partners.
FAQ
What is the AACR Special Conference on Pediatric Cancer?
The AACR Special Conference focuses on the latest research and developments in pediatric cancer, featuring expert discussions and presentations.
When will the oral presentation by Cellectar take place?
The oral presentation is scheduled for September 26, 2025, at 2:50 p.m. Eastern time.
What is the focus of Cellectar's CLOVER-2 trial?
The CLOVER-2 trial focuses on the safety and efficacy of iopofosine I 131 in treating pediatric high-grade gliomas.
What are pediatric high-grade gliomas?
Pediatric high-grade gliomas are aggressive brain tumors that primarily affect children and young adults, with poor survival rates.
What designations has iopofosine I 131 received from the FDA?
iopofosine I 131 has received six Orphan Drug, four Rare Pediatric Drug, and two Fast Track Designations from the FDA.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
FLORHAM PARK, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the acceptance of an abstract for oral presentation followed by a 55-minute panel discussion with other experts in this area at the American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer taking place September 25-28 in Boston, Massachusetts. The oral presentation will highlight interim data from the Phase 1b dose and regimen optimization study of iopofosine I 131 in inoperable relapsed or refractory pediatric high-grade glioma (r/r pHGG).
“We are honored that the AACR peer review process has led to the selection of our abstract for a plenary session presentation regarding the treatment of pediatric high-grade glioma patients with iopofosine I 131,” said Jarrod Longcor, chief operating officer of Cellectar. “We are highly encouraged with these initial findings from the CLOVER-2 trial in pediatric patients and believe this outcome further validates the clinical potential of iopofosine I 131 to treat aggressive cancers for patients with limited treatment options.”
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Details of the poster presentation are as follows:
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| Title: | “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” | |
| Session: | Plenary Session 3: From Targets to Trials: Rethinking How We Design Child-First Medicine | |
| Track: | Scientific Presentations: Navigating the landscape of paediatric oncology modalities | |
| Date/Time: | September 26, 2025, 2:50 pm Eastern time | |
| Presenter: | Jarrod Longcor | |
About Pediatric High-Grade Gliomas
Pediatric high-grade gliomas are a collection of aggressive tumors affecting the brain and central nervous system. The patients enrolled in CLOVER-2 with pHGG (n=14) were diagnosed with diffuse midline gliomas (DMG), ependymomas, diffuse intrinsic pontine gliomas (DIPG), diffuse hemispheric gliomas (DHG) and anaplastic ependymomas. As reported in the literature, median progression free survival (PFS) and overall survival (OS) for patients with relapsed pHGG is poor; approximately 2.25 months and 5.6 months, respectively. While MRI measures of tumor volume change can be helpful and are used as a surrogate in clinical trials, they often fail to predict survival.
About the CLOVER-2 Trial
The ongoing Phase 1b trial of iopofosine I 131 consists of children, adolescents and young adults with r/r pHGG at multiple sites in the United States and Canada. The study is designed to evaluate the safety and tolerability of iopofosine I 131 in two dosing cohorts, one cohort receiving two doses at 20mCi/m2 each separated by 14 days for two cycles with a third optional cycle. Patients in the second cohort will receive 10 mCi/m2 each, separated by 14 days for three cycles with a fourth optional cycle. The study will also determine therapeutic activity defined as progression free survival (PFS) and overall survival, antitumor activity defined as the reduction in tumor volume and identify the recommended Phase 2/3 dose of iopofosine I 131 in children, adolescents and young adults with r/r pHGG.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes its lead assets: iopofosine I 131, a PDC designed to provide targeted delivery of iodine-131 (radioisotope); CLR 121225, an actinium-225 based program being targeted to several solid tumors with significant unmet need, such as pancreatic cancer; and CLR 121125, an iodine-125 Auger-emitting program targeted in other solid tumors, such as triple negative breast, lung and colorectal, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
In addition, iopofosine I 131 has been studied in Phase 2b trials for relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma, and the CLOVER-2 Phase 1b 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 Rare Pediatric Drug and two Fast Track Designations for various cancer indications.
For more information, please visit www.cellectar.com or join the conversation by liking and following us on the company’s social media channels: X , LinkedIn , and Facebook .
Forward Looking Statements Disclaimer
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the FDA and EMA regulatory pathways, ability to execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2024, and our Form 10-Q for the quarterly period ending June 30, 2025. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
[email protected]
