Full Press Release Details
Data from DLBCL Cohort of its Phase 2 CLOVER-1 Study at the European Society for Medical Oncology (ESMO) Congress
durable clinical responses, including a 33% overall response rate (ORR) and 16.6% complete response (CR)
N.J., September 30, 2019 -- 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 Jarrod
Longcor, chief business officer of Cellectar, presented data from the diffuse large B cell lymphoma (DLBCL) cohort in the company's
Phase 2 CLOVER-1 study of CLR 131 in relapsed or refractory select B-cell malignancies at the European Society for Medical Oncology
(ESMO) Congress 2019 being held from September 27 - October 1, 2019 in Barcelona, Spain.
The oral presentation,
entitled: "Interim Evaluation of a Targeted Radiotherapeutic, CLR 131, in Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Patients (R/R DLBCL)," featured data from 6 subjects who received a single 30-minute intravenous (IV) dose of 25mCi/m2
of CLR 131. Data showed durable responses, including a 33% overall response rate (ORR), a 16.6% complete response rate (CR) and
a 50% clinical benefit rate (CBR). All patients enrolled in the study received an average of 3 prior lines of systemic therapy,
5 of 6 patients were refractory to at least one prior line of therapy. Importantly, CLR 131 showed activity against both germinal
center and activated DLBCL. In a patient for whom cytogenetics was available, CLR 131 showed activity against c-Myc and BCL-2 mutation
(single & dual-hit) positive patients. As required by the Lugano Criteria for Response, the patient who experienced a CR had
a total reduction in tumor volume of greater than 99% and continues to be a CR at 510+ days post dosing. This patient was refractory
to two prior treatment lines, which included the combination regimen RICE.
showed that the disease control rate and progression free survival were markedly improved in patients receiving a dosing ratio
of 1.2% or greater (drug to tumor volume) versus those receiving below a 1.2% dosing ratio. Finally, the most frequent adverse
events (AE) in DLBCL patients were consistent with prior studies of CLR 131; the majority of AEs being hematologic in nature and
predominately Grades 1 and 2.
presented show an encouraging overall response rate including a complete response at the time of the interim assessment after a
single 30-minute IV dose of 25mCi/m2 of CLR 131. We remain optimistic that
CLR 131 has the potential to provide a meaningful treatment option for a variety of lymphoma patients and look forward to reporting
additional data from this Phase 2 CLOVER-1 study in 2019," said James Caruso, president and CEO of Cellectar. "The
study remains ongoing and, based on this cohort and additional data from an ongoing dose escalation Phase 1 study, patients in
the Phase 2 CLOVER-1 study are now receiving a higher 37.50 mCi/m2 fractionated dose administered in two 30-minute infusions
About the Phase 2 CLOVER-1 Trial
Phase 2 study of CLR 131 being conducted in approximately 10 leading cancer centers in the United States in patients with relapsed
or refractory B-cell hematologic cancers. The hematologic cancers being studied in the trial include multiple myeloma (MM), chronic
lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle
cell lymphoma (MCL), and diffuse large B-cell lymphoma (DLBCL).
enroll up to 80 patients. Its primary endpoint is clinical benefit response (CBR), with additional endpoints of overall response
rate (ORR), progression free survival (PFS), median overall survival (OS) and other markers of efficacy following a fractionated
dose of 37.575mCi/m2 of CLR 131 administered in two 30-minute infusions of 18.75mCi/m2 of CLR 131
administered on day 1 and day 8, with the option for a second dose cycle approximately 75-180 days later. The company expects to
report topline data in 2019.
awarded approximately $2 million in non-dilutive grant funding from the National Cancer Institute to help fund the trial. More
information about the trial, including eligibility requirements, can be found at www.clinicaltrials.gov, reference
CLR 131 is a small-molecule, cancer-targeting
radiotherapeutic Phospholipid Drug ConjugateTM (PDC) designed to deliver cytotoxic radiation directly and selectively
to cancer cells and cancer stem cells. CLR 131 is the company's lead therapeutic PDC product candidate and is currently being
evaluated in both Phase 2 and Phase 1 clinical studies. The FDA granted orphan drug designation for CLR 131 for the treatment of
multiple myeloma as well as orphan drug and rare pediatric disease designations for CLR 131 for the treatment of neuroblastoma,
rhabdomyosarcoma, Ewing's sarcoma and osteosarcoma. In addition to the ongoing Phase 1 dose-escalation study and the Phase
2 (CLOVER-1) trial, the company recently initiated a Phase 1 open-label, dose-escalating study in pediatric solid tumors and lymphoma
to evaluate the safety and tolerability of a single intravenous administration of CLR 131 in up to 30 children and adolescents
with cancers including neuroblastoma, sarcomas, lymphomas (including Hodgkin's lymphoma) and malignant brain tumors.
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 (R&D) collaborations. The company's core objective
is to leverage its proprietary Phospholipid Drug ConjugateTM (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.
lead PDC therapeutic, CLR 131, is currently in three clinical studies - a Phase 2 study, and two Phase 1 studies. The Phase
2 clinical study (CLOVER-1) is in relapsed/refractory (R/R) B-cell malignancies, including multiple myeloma (MM), chronic lymphocytic
leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL), marginal zone lymphoma (MZL), mantle cell lymphoma
(MCL), and diffuse large B-cell lymphoma (DLBCL). The company is also conducting a Phase 1 dose escalation study in patients with
R/R multiple myeloma (MM) and a Phase 1 study in pediatric solid tumors and lymphoma.
product pipeline also includes one preclinical PDC chemotherapeutic program (CLR 1900) and several partnered PDC assets.
For more information,
please visit www.cellectar.com.
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. 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, the completion of clinical trials, the FDA review process and other government regulation, 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, 2018 and Form 10-Q for the quarters ended March 31, 2019 and June 30, 2019. These forward-looking
statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.