Cellectar Biosciences Reports Complete Central Nervous System (CNS) Clearance in Relapsed/Refractory Waldenstrom’s Macroglobulinemia Patient
January 22 2024 - 5:40AM
Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical
biopharmaceutical company focused on the discovery, development and
commercialization of drugs for the treatment of cancer, today
announced that its novel phospholipid radiotherapeutic conjugate,
iopofosine I 131, demonstrated a pathological response with
complete clonal clearance in a relapsed/refractory Waldenstrom’s
macroglobulinemia (WM) patient with CNS involvement, also known as
Bing-Neel Syndrome (BNS), enrolled in its Phase 2b CLOVER WaM
pivotal trial.
“Attainment of complete CNS clearance in a patient
with Bing-Neel Syndrome after previous exposure to BTKi therapy is
encouraging,” commented Jorge Castillo, M.D., associate professor
at Harvard Medical School and director of Bing Center Clinic at
Dana Farber Cancer Institute. “The ability of iopofosine I 131 to
deliver an effective therapeutic payload across the blood-brain
barrier with the eradication of the tumor clone in the
cerebrospinal fluid is a valuable treatment attribute for WM
patients with relapsed or refractory CNS disease. The potential
approval of this novel agent may provide a meaningful therapeutic
option for a patient population with limited available
treatments.”
As part of the CLOVER WaM pivotal trial, the
patient with BNS received the standard WM dosing regimen of two
treatment cycles with two doses per cycle for a total of four fixed
doses of iopofosine I 131 over 75 days. The patient received the
recommended total administered dose of greater than 60mCi.
Cerebrospinal fluid flow cytometry showed no evidence of clonal
B-cells, and molecular analysis did not detect the MYD88
mutation.
“This confirmed pathologic response with iopofosine
I 131 in a malignancy with CNS involvement further validates the
potential of our phospholipid radiotherapeutic conjugate to treat
CNS malignancies,” said Dr. Andrei Shustov, senior vice president,
medical of Cellectar. “Similar to WM patients, there is no standard
of treatment and limited therapeutic options for patients with
Bing-Neel Syndrome, a more complicated condition and treatment
challenge. This very encouraging patient response further supports
iopofosine’s development in CNS-related malignancies, including CNS
lymphoma and pediatric high-grade gliomas.”
Cellectar previously announced a complete response
in a patient with relapsed/refractory primary central nervous
system lymphoma (CNSL) as part of its ongoing Phase 2a trial of
iopofosine I 131. Currently, there are no approved therapies
available to CNSL patients.
Additionally, with the support of a $2 million
grant from the National Institute of Health’s National Cancer
Institute (NCI), during the third quarter of 2023, Cellectar
initiated a Phase 1b study in pediatric high-grade gliomas (pHGGs),
which is currently enrolling. The study objective is to identify
the recommended iopofosine I 131 Phase 2 dose in pHGG patients. The
NCI funding was in part granted due to the Phase 1a trial data
demonstrating five months of progression free survival, which is
substantially greater than what is typically observed in
relapsed/refractory patients.
About Cellectar Biosciences,
Inc.Cellectar Biosciences is a late-stage clinical
biopharmaceutical company focused on the discovery and development
of proprietary drugs for the treatment of cancer, 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 the next-generation
of cancer cell-targeting treatments, delivering improved efficacy
and better safety as a result of fewer off-target effects.
The company’s product pipeline includes lead asset
iopofosine I 131, a small-molecule PDC designed to provide targeted
delivery of iodine-131 (radioisotope), proprietary preclinical PDC
chemotherapeutic programs and multiple partnered PDC assets.
For more information, please
visit www.cellectar.com
and www.wmclinicaltrial.com or join the conversation by
liking and following us on the company’s social media
channels: Twitter, LinkedIn, and Facebook.
About Waldenstrom’s Macroglobulinemia and
Bing-Neel SyndromeWM is a B-cell malignancy characterized
by bone marrow infiltration of clonal lymphoplasmacytic cells that
produce a monoclonal immunoglobulin M (IgM) that remains incurable
with available treatments. The prevalence in the US is
approximately 26,000 with 1,500-1,900 patients being diagnosed
annually. Approximately 10,000 patients require treatment in the
relapsed or refractory setting and there are an estimated 4,300
patients requiring 3rd line or greater therapy. There are no FDA
approved treatment options for patients progressing on BTKi
therapy. BTKi therapies do not demonstrate complete response rates
and require continuous treatment. Approximately 50% of 3rd line
patients not receiving treatment are likely to consider new
treatment options. There is an established unmet need for new FDA
approved treatments that provide a novel mechanism of action,
increased deep durable responses, and time limited treatment,
especially in heavily pretreated WM patients.
Bing-Neel Syndrome is a rare neurological
complication of WM that results from infiltration of the central
nervous system by malignant lymphoplasmacytic cells. The median
time from initial diagnosis of WM to development of BNS is 3.5
years.
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 regarding the WM CLOVER-WaM pivotal trial. 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 iopofosine, 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 iopofosine, 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, 2022, and our Form 10-Q for the quarter ended
September 30, 2023. These forward-looking statements are made only
as of the date hereof, and we disclaim any obligation to update any
such forward-looking statements.
Contacts
MEDIA:Claire LaCagninaBliss Bio
Health315-765-1462clacagnina@blissbiohealth.com
INVESTORS:Chad KoleanChief Financial
Officerinvestors@cellectar.com
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