Cellectar Biosciences Announces Poster Presentation at the 63rd American Society for Hematology Annual Meeting and Exposition

Rhea-AI Summary

On December 8, 2021, Cellectar Biosciences (NASDAQ: CLRB) announced a poster presentation at the ASH Annual Meeting, showcasing data from the ongoing Phase 2 CLOVER-1 study of iopofosine I-131. The study focuses on eleven patients with triple-class refractory multiple myeloma, highlighting preliminary efficacy and safety results. The poster session will occur on December 11, 2021. Iopofosine is designed for targeted cancer treatment and is undergoing multiple clinical studies, including a pivotal trial for Waldenstrom's macroglobulinemia.

Positive

• Presentation at ASH Annual Meeting could enhance visibility and credibility of iopofosine I-131.
• Positive preliminary results from CLOVER-1 study may attract investor interest and confidence.

Negative

• Limited data from only eleven patients could raise concerns about the robustness of results.
• Dependence on successful outcomes of ongoing studies to secure market approval poses risks.

FLORHAM PARK, N.J., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced a poster presentation featuring data from the company’s ongoing Phase 2 CLOVER-1 study of iopofosine I-131 at the American Society of Hematology (ASH) Annual Meeting and Exposition being held virtually December 11-14, 2021.

The poster will highlight data from eleven multiple myeloma patients who were at least triple class refractory (immunomodulatory agent, proteasome inhibitor and monoclonal antibody) that were treated with iopofosine I-131 in the company’s Phase 2 CLOVER-1 study, with data current as of the end of May 2021.

Details for the poster presentation are as follows:

Title:	CLR 131 (Iopofosine I-131) Treatment in Triple Class Refractory and Beyond Multiple Myeloma Patients: Preliminary Efficacy and Safety Results from the Phase 2 CLOVER-1 Trial
Session/Title:	653/Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Abstract:	1652
Authors:	Sikander Ailawadhi; Patrick Stiff; Emad Ibrahim; Damian J. Green; Brea Lipe; Elizabeth H. Cull; Natalie S. Callander; John Friend; Jarrod Longcor, and Kate Oliver
Date/Time:	Saturday, December 11, 2021 at 5:30 pm – 7:30 pm

A copy of the poster will be available after the presentation on the News and Events section of the company’s website.

About iopofosine (also known as CLR 131)
Iopofosine is a small-molecule Phospholipid Drug Conjugate™ designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.

About Cellectar Biosciences, Inc.
Cellectar Biosciences is focused on the discovery and development of drugs for the treatment of cancer. The company is developing proprietary drugs 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 PDCs that specifically target cancer cells, delivering improved efficacy and better safety as a result of fewer off-target effects. The company’s PDC platform possesses the potential for the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development collaborations.

The company’s product pipeline includes iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), and proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the Phase 1 CLOVER-2 study.

The Phase 1 pediatric study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin’s lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.

For more information, please visit www.cellectar.com and www.wmclinicaltrial.com or join the conversation by liking and following us on the company’s social media channels: Twitter, LinkedIn, and Facebook.

Forward-Looking Statement 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 including our expectations of the impact of the COVID-19 pandemic. 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 ability to raise additional capital, uncertainties related to the disruptions at our sole source supplier of iopofosine, the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for iopofosine, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. 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, 2020, and our Form 10-Q for the quarter ended September 30, 2021. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.

Contacts

Investors:

Monique Kosse
Managing Director
LifeSci Advisors
212-915-3820
monique@lifesciadvisors.com

FAQ

What is the significance of the ASH Annual Meeting for Cellectar Biosciences (CLRB)?

The ASH Annual Meeting provides a platform for presenting significant findings from the Phase 2 CLOVER-1 study of iopofosine I-131.

What are the preliminary results shared by Cellectar Biosciences regarding iopofosine I-131?

Cellectar reported preliminary efficacy and safety results from eleven patients with triple-class refractory multiple myeloma in their CLOVER-1 study.

When was the poster presentation for the CLOVER-1 study scheduled?

The poster presentation is scheduled for December 11, 2021, at the ASH Annual Meeting.

What is iopofosine I-131 used for?

Iopofosine I-131 is being investigated for targeted treatment of multiple myeloma and other cancers through its Phospholipid Drug Conjugate™ technology.

What does the 'triple-class refractory' designation mean for patients in the CLOVER-1 study?

'Triple-class refractory' indicates that the patients have not responded to three different classes of treatment, highlighting the severity of their condition.