Cellectar Biosciences to Present Compelling Efficacy Data from Phase 2 CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Refractory/Resistant to BTK Inhibitor Therapy at International Workshop for Waldenström Macroglobulinemia
Results in a heavily pretreated subgroup support Cellectar's planned confirmatory trial and potential U.S. application.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Cellectar Biosciences (CLRB) reported a 79.2% major response rate in a Phase 2 CLOVER-WaM subgroup treated with iopofosine I 131. The analysis covered patients with Waldenström macroglobulinemia who received the treatment immediately after BTK inhibitor therapy and had received at least two prior treatment lines. The overall response rate was 87.5%, and duration of response exceeded 16 months. The data are scheduled for presentation on October 15, 2026.
Cellectar plans to dose patients in a confirmatory Phase 3 trial in early 2027 and file a U.S. accelerated-approval application in the first half of 2027. The treatment has Breakthrough Therapy Designation. Cellectar expects a six-month review and sees potential approval by the end of 2027.
Positive
- Minor pointMajor response rate was 79.2% in the post-BTK inhibitor subgroup.
- Minor pointOverall response rate was 87.5% in the same subgroup.
- Minor pointDuration of response exceeded 16 months in the subgroup analysis.
- Minor point. Forward-looking: it has not happened yet and may not happen.Phase 3 patient dosing is targeted for early 2027.
- Minor pointBreakthrough Therapy Designation has been granted to iopofosine I 131.
Negative
- Minor point. Forward-looking: it has not happened yet and may not happen.U.S. accelerated approval remains potential; Cellectar plans to file its application in the first half of 2027.
Details
Market Reaction – CLRB
On Sep 29, the day this news came out, the latest delayed price for CLRB is 7.65% above the previous close. The latest delayed price is $1.97. Relative volume is exceptionally heavy at 6.3x the average.
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Key Figures
- Major response rate
- 79.2%
- Phase 2 CLOVER WaM subset analysis
- Overall response rate
- 87.5%
- Phase 2 CLOVER WaM subset analysis
- Duration of response
- Exceeding 16 months
- Phase 2 CLOVER WaM subset analysis
- Prior treatment lines
- At least 2
- Patients treated immediately following BTK inhibitor therapy
- Confirmatory trial dosing
- Early 2027
- Planned Phase 3 trial
- NDA filing
- First half of 2027
- Planned filing for accelerated approval
- Expected review duration
- Six months
- Company expectation following filing
- Potential approval timing
- By the end of 2027
- Company expectation
Historical Context
-
Earlier Phase 2b CLOVER WaM report gave matching response rates for patients treated after BTK inhibitors.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
btk inhibitor medical
waldenström macroglobulinemia medical
new drug application regulatory
accelerated approval regulatory
breakthrough therapy designation regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Demonstrated Major Response Rate of
Data Further Support Company’s Plans to Advance Iopofosine I 131 in Phase 3 Confirmatory Trial and Submit for U.S. Accelerated Market Approval in 1H27
FLORHAM PARK, N.J., Sept. 29, 2026 (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 that a subset analysis of data from the company’s Phase 2 CLOVER WaM clinical trial that support the potential of iopofosine I 131 as a potential treatment option for Waldenström Macroglobulinemia (WM) patients who are refractory or resistant to BTK inhibitor therapy will be highlighted in a presentation at the upcoming International Workshop for Waldenström Macroglobulinemia (IWWM) taking place October 14 - 16, 2026 in Palm Springs, California.
“We are pleased to present these data from the CLOVER-WaM study at IWWM and share additional evidence supporting the potential of iopofosine I 131 to address a significant unmet need for patients with WM. This analysis evaluated patients who received iopofosine I 131 immediately following BTK inhibitor therapy after at least two prior lines of treatment, representing a particularly challenging, heavily pretreated population,” said Jarrod Longcor, chief operating officer at Cellectar Biosciences. “We remain on-target to dose patients in the confirmatory Phase 3 clinical trial in early 2027 and to file our New Drug Application for accelerated approval in the first half of 2027. Given iopofosine I 131 has Breakthrough Therapy Designation, we expect a six-month review with a potential approval by the end of 2027.”
Details of the upcoming poster presentation are as follows:
| Title: | “Iopofosine I 131 After BTK Inhibitors in Waldenström Macroglobulinemia: CLOVER-WaM Subgroup Efficacy and Safety” |
| Session #: | 14 |
| Date/Time: | October 15, 2026, 4:00 PM |
| Location: | Sierra-Ventura Hall |
| Presenter: | Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences |
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 iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in 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 granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation.
Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth.
In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit https://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, 2025, and our Form 10-Q for the quarterly period ending June 30, 2026. 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
annemarie.fields@precisionaq.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Cellectar's CLOVER-WaM subgroup analysis show?
The subgroup had a 79.2% major response rate and an 87.5% overall response rate, with duration of response exceeding 16 months. It included patients treated with iopofosine I 131 immediately after BTK inhibitor therapy following at least two prior treatment lines.
When does Cellectar plan to seek accelerated approval for iopofosine I 131?
Cellectar plans to file a U.S. accelerated-approval application in the first half of 2027. It expects a six-month review and sees potential approval by the end of 2027; neither the filing nor approval has occurred.