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Cellectar Reports Data on CLR 131 Phase 2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients 40% overall response rate (ORR) with a total administered dose of 60 mCi or greater

Key Takeaway: Cellectar Reports Data on CLR 131 Phase 2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients 40% overall response rate (ORR) with a total administered dose of 60 mCi or greater FLORHAM PARK, N.J., September 9, 2020 -- Cellectar Biosciences, Inc. (NASDAQ: CLR

Full Press Release Details

Cellectar Reports Data on CLR 131 Phase
2 CLOVER-1 Study in Triple Class Refractory Multiple Myeloma Patients
40% overall response rate (ORR) with
a total administered dose of 60 mCi or greater
FLORHAM PARK, N.J., September 9,
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 that a clinically meaningful 40% overall response rate
(ORR) was observed in the subset of refractory multiple myeloma patients deemed triple class refractory who received a total administered
dose of 60 mCi or greater. Triple class refractory is defined as patients refractory to immunomodulatory, proteasome inhibitors
and anti-CD38 antibody drug classes.
The 40% ORR (6/15 patients) represents
triple class refractory patients enrolled in Part A of Cellectar's CLOVER-1 study and additional patients enrolled in Part
B from March through May 2020. As a reminder, all patients being enrolled in Part B are required to be triple class refractory.
The additional six patients were heavily pre-treated with an average of 9 prior multi-drug regimens. Three patients received a
total administered dose of greater than 60 mCi and three received less than 60 mCi. Consistent with the data released in February
2020, patients receiving greater than 60 mCi exhibit strong responses. Patients continue to tolerate CLR 131 well, with the most
common and almost exclusive treatment emergent adverse events being cytopenias and importantly, no unexpected adverse events have
"We remain encouraged by the consistency
of CLR 131's efficacy and tolerability data in these extremely challenging to treat triple class refractory multiple myeloma
patients," said Dr. John Friend, CMO of Cellectar Biosciences. "A 40% ORR is a clinically meaningful outcome. For reference
purposes, two recently approved drugs received a 25% and 31% ORR in triple class refractory patients. We look forward to the further
development of CLR 131, a first in class phospholipid radio conjugate that may provide a significant benefit to patients and treatment
alternative for clinicians."
The Phase 2 CLOVER-1 study is an open-label
study designed to determine the efficacy and safety of CLR 131 in select B-cell malignancies. 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 60 mCi total body dose and 2 cycle doses as patients have demonstrated a clinically meaningful
response and predictable safety profile of CLR 131 in r/r multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom's
macroglobulinemia (LPL/WM). Patients with LPL/WM must have received at least two prior treatment regimens, unless ineligible to
receive standard agents, and have measurable disease, as defined by either a nodal lesion of >15 mm, an extranodal lesion of
>10 mm, or measurable IgM. Prior external beam radiation therapy was allowed. The median age of the four LPL/WM patients enrolled
in the study was 70 (range 54-81) and included 2 females and 2 males who had a median of two prior regimens (range 1-5). CLR 131
was administered intravenously, up to 30 minutes.
Cellectar was 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.
CLR 131 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 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. Earlier this year, the European Commission
granted an ODD for r/r multiple myeloma and most recently, the U.S. Food and Drug Administration granted Fast Track Designation
for CLR 131 in lymphoplasmacytic lymphoma (LPL)/Waldenstrom's macroglobulinemia (WM) in patients having received two prior
treatment regimens or more.
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 100 mCi total body dose of CLR 131 in 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 is 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 seven 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
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 quarters ended March
31, 2020 and June 30, 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.
Last updated: Sep 9, 2020