Full Press Release Details
Cellectar Announces Expansion of Diffuse Large B-Cell Lymphoma Cohort in CLR 131 Phase 2 Trial
Response rate in cohort exceeded pre-specified
Madison, Wis. (June 28, 2018) - Cellectar Biosciences,
Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of
targeted treatments for cancer, today announces that the company will expand patient enrollment in the diffuse large b-cell lymphoma
(DLBCL) cohort of its currently enrolling Phase 2 clinical trial of CLR 131.
The response rate of the DLBCL cohort exceeded pre-specified
criteria. As a result, the company will expand the cohort up to an additional 30 patients. This group represents the second of
four cohorts to be expanded in this Phase 2 study. Previously the company announced the expansion of the study's multiple
myeloma (MM) cohort. Additional updates on the two remaining select B-cell lymphoma cohorts will be provided when data are available.
"Relapse or refractory DLBCL is an aggressive cancer and
the initial response rates from the cohort leave us optimistic in CLR 131's potential to have a positive impact on patients
with life-threatening hematologic cancers. We continue to see clinical benefit using CLR 131 across a range of cancer types and
we look forward to providing future data updates on this indication and others," stated James Caruso, president and chief
executive officer of Cellectar Biosciences.
About the Phase 2 Study of CLR 131
The Phase 2 study is being conducted in approximately 10 leading
cancer centers in the United States for patients with relapsed or refractory B-cell hematologic cancers. The hematologic cancers
being studied include (MM, chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), lymphoplasmacytic lymphoma (LPL),
marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), and potentially diffuse large B-cell lymphoma (DLBCL).
The study's primary endpoint is clinical benefit response (CBR),
with additional endpoints of progression free survival (PFS), median overall survival (OS) and other markers of efficacy following
a single 25.0 mCi/m2 dose of CLR 131, with the option for a second 25.0 mCi/m2 dose approximately 75-180
In addition to the CLR 131 infusion(s), MM patients will receive
40 mg oral dexamethasone weekly for up to 12 weeks. Efficacy responses will be determined by the latest International Multiple
Myeloma Working Group criteria. Efficacy for all lymphoma patients will be determined according to Lugano criteria. Cellectar has
been awarded approximately $2 million in a non-dilutive grant 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 NCT02952508.
About Diffuse Large B-Cell Lymphoma
According to the Lymphoma Research Foundation, diffuse large
B-cell lymphoma (DLBCL) is an aggressive form of non-Hodgkin's lymphoma (NHL), accounting for about 30 percent of newly diagnosed
cases of NHL in the United States.
The American Cancer Society's most recent estimates for
NHL for 2018 project approximately 74,680 people (41,730 males and 32,950 females) will be diagnosed with NHL including both adults
and children. They estimate that approximately 19,910 people will die from this cancer (11,510 males and 8,400 females).
DLBCL occurs in both men and women, although it is slightly
more common in men. Although DLBCL can occur in childhood, its incidence generally increases with age, and roughly half of patients
are over the age of 60.
DLBCL is an aggressive (fast-growing) lymphoma that
can arise in lymph nodes or outside of the lymphatic system, in the gastrointestinal tract, testes, thyroid, skin, breast, bone,
or brain. Often, the first sign of DLBCL is a painless, rapid swelling in the neck, underarms, or groin that is caused by enlarged
lymph nodes. For some patients, the swelling may be painful. Other symptoms may include night sweats, fever, and unexplained weight
loss. Patients may notice fatigue, loss of appetite, shortness of breath, or pain.
About Phospholipid Drug Conjugates (PDCs)
Cellectar's product candidates are built upon a patented delivery
and retention platform that utilizes optimized PDCs to target cancer cells. The PDC platform selectively delivers diverse oncologic
payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows
the payloads' therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and
severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle
stages. Compared with other targeted delivery platforms, the PDC platform's mechanism of entry does not rely upon specific
cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types
of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the
next generation of cancer-targeting agents.
CLR 131 is Cellectar's investigational radioiodinated
PDC therapy that exploits the tumor-targeting properties of the company's proprietary phospholipid ether (PLE) and PLE analogs
to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in
a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in
patients with (R/R) MM exploring fractionated dosing. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric
solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is focused on the discovery, development
and commercialization of drugs for the treatment of cancer. The company plans to develop proprietary drugs independently and through
research and development (R&D) collaborations. The core drug development strategy is to leverage our PDC platform to develop
therapeutics that specifically target treatment to cancer cells. Through R&D collaborations, the company's strategy is
to generate near-term capital, supplement internal resources, gain access to novel molecules or payloads, accelerate product candidate
development and broaden our proprietary and partnered product pipelines.
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. 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 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, 2017. These forward-looking statements are made only as of the
date hereof, and we disclaim any obligation to update any such forward-looking statements.
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