Full Press Release Details
Announces Poster Presentation of Clinical Data at the American Association of Cancer Research (AACR) Annual Meeting
initial results of 100% overall response rate from ongoing Phase 2 trial in Relapsed or Refractory lymphoplasmacytic lymphoma (LPL)/Waldenstrom's
Macroglobulinemia (WM)
N.J., July 21, 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 American Association of Cancer Research (AACR) annual meeting being held virtually on August 17-19, 2020.
Poster presentation details:
presentation materials can be accessed on the Events and Presentations section of the
Cellectar website once the presentation has concluded.
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 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.
Phase 2 CLOVER-1 Study
a Phase 2 study of CLR 131 being conducted in 10 leading cancer centers in the United States in patients with relapsed/refractory
B-cell hematologic cancers. The hematologic cancers studied include multiple myeloma (MM), chronic lymphocytic leukemia/small lymphocytic
lymphoma (CLL/SLL), lymphoplasmacytic lymphoma/ Waldenstrom's macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), mantle
cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).
enroll up to 80 patients with its primary endpoint being clinical benefit response (CBR), which is defined as the proportion of
MM patients following infusion of CLR 131 with stringent complete response, complete response, very good partial response, partial
response and stable disease per International Myeloma Working Group criteria, or the proportion of lymphomas patients (CLL/SLL,
LPL, MZL, MCL, and DLBCL) following infusion of CLR 131 with CR, PR and SD per the Lugano classification CT-based response criteria
or International Waldenstrom's Macroglobulinemia Society criteria or the International Chronic Lymphocytic Leukemia criteria.
Additional endpoints include overall response rate (ORR), progression free survival (PFS), median overall survival (OS) and other
markers of efficacy. Patients were treated with three different doses (<60mCi single cycle, >60mCi single cycle and
>60 mCi multi-cycle total body dose).
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 in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom's
macroglobulinemia (LPL/WM). Part B is evaluating the two cycle dosing of CLR 131 in additional patients. Each cycle is defined
as two doses provided 14 days apart (+/- 1 day). Cycle 2 shall be given 8-weeks post the initial infusion. Additional cycles can
be considered following an additional 8-week period. The Part A portion of the study met its primary and secondary endpoints with
detailed data being announced on February 19, 2020.
awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the study. More
information about the study, including eligibility requirements, can be found at www.clinicaltrials.gov,
reference NCT02952508.
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
company is also conducting a two-part Phase 1 dose-escalation with expansion arms in pediatric solid tumors and lymphomas.
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, 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 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.