Full Press Release Details
Poster Presentation at the International Symposium on Pediatric Neuro-Oncology (ISPNO) Annual Meeting
results from the Phase 1 study of CLR 131 in children and adolescents with relapsed/refractory malignancies
N.J., August 4, 2020 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused
on the discovery, development and commercialization of drugs for the treatment of cancer, today announced a poster presentation
at the upcoming rescheduled International Symposium on Pediatric Neuro-Oncology (ISPNO) annual meeting taking place December 13-16
in Karuizawa, Japan.
investigators, Dr. Diane Puccetti, a faculty member of the University of Wisconsin School of Medicine and Public Health and Medical
Director of the American Family Children's Hospital will present the poster, entitled: "CLR 131 in patients with
relapsed or refractory pediatric malignancies," which highlights Phase 1 study data including subjects with various brain
(NCT03478462) is an open-label
dose escalation study of CLR 131 in children and adolescents with relapsed or refractory cancers, including malignant brain tumors,
neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma and lymphomas (including Hodgkin's lymphoma). Patients
in the study have received infusions of CLR 131 in escalating dose levels. To date, all doses have been deemed safe and tolerated
by the independent Data Monitoring Committee, including the 60mCi/m2 dose level.
presentation materials can be accessed on the Events and Presentations section of the Cellectar website once the presentation
small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to
cancer cells, while limiting exposure to healthy cells unlike many traditional on-market treatment options. CLR 131 is the company's
lead product candidate and is currently being evaluated in a Phase 2 study in B-cell lymphomas, and a Phase 1 dose-escalating clinical
study in pediatric solid tumors and lymphomas. The company recently completed a Phase 1 dose-escalation clinical study in relapsed/refractory
(r/r) multiple myeloma. The FDA granted CLR 131 Fast Track Designation for both r/r multiple myeloma and r/r diffuse large b-cell
lymphoma and Orphan Drug Designation (ODD) for the treatment of multiple myeloma, lymphoplasmacytic lymphoma/Waldenstrom's
macroglobulinemia, neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. CLR 131 was also granted Rare Pediatric
Disease Designations for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. Most recently,
the European Commission granted an ODD for r/r multiple myeloma.
Cellectar Biosciences is focused on the
discovery, development and commercialization 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 lead PDC therapeutic,
CLR 131, is currently in two clinical studies. The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion, conducted
in relapsed/refractory (r/r) B-cell malignancies, and is now enrolling in the Part B expansion cohorts evaluating a two cycle dosing
regimen that provides approximately 100mCi total body dose of CLR 131 in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic
lymphoma/Waldenstrom's macroglobulinemia (LPL/WM). The data from the Part A portion was announced on February 19, 2020.
The Phase 1 pediatric study will be an
open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of CLR 131 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 7 leading pediatric cancer centers.
The company's product pipeline includes
one preclinical PDC chemotherapeutic program (CLR 1900) and multiple partnered PDC assets.
For more information, please visit www.cellectar.com
or join the conversation by liking and following us on the company's social media channels: Twitter, LinkedIn,
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 recent
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 CLR 131, 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 CLR
131, 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, 2019 and our Form 10-Q for the quarter ended March 31, 2020.
These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking
statements. These forward looking statements are made only as of the date hereof, and we disclaim any obligation to update any
such forward-looking statements.