Cellectar Biosciences Broadens Pipeline with Targeted Alpha Therapy (TAT) for Solid Tumors and Releases Promising Preclinical Data
January 16 2024 - 6:40AM
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 promising preclinical data for its proprietary novel
alpha-emitting phospholipid radiotherapeutic conjugate, CLR 121225
(225Ac-CLR 121225) an actinium-labeled phospholipid ether (PLE), in
pancreatic cancer models. The development of this compound will
expand the company’s clinical pipeline of PLE cancer targeting
compounds to include targeted alpha therapies (TATs), complementing
its beta-emitting phospholipid radiotherapeutic conjugate,
iopofosine I 131, which achieved its primary endpoint in the CLOVER
WaM pivotal study in highly refractory Waldenstrom’s
macroglobulinemia patients.
Cellectar’s PLE platform may provide unique
advantages which overcome the issues experienced by existing TAT
delivery platforms. While current TAT platforms, such as antibodies
and peptides, possess the potential to be effective for treating
cancers with low tumor volume, they are challenged to treat higher
volume or bulky tumors due to insufficient penetration and the need
for high quantities of the target epitope. Cellectar’s PLE’s
possess biochemical properties that enable penetration of the TAT
payload deep into the tumor mass and the abundance of lipid rafts
on tumor cells provides near universal delivery and enhanced
outcomes.
“The advancement of our TAT program is part of
our overall strategy to develop a comprehensive portfolio of first-
and best-in-class radiotherapeutics designed to treat both blood
cancers and solid tumors that now includes both alpha and
beta-emitting radiotherapeutics,” commented James Caruso, president
and CEO of Cellectar. “Our promising preclinical data with
actinium-225 highlights the potential utility of our PLE platform
to provide targeted delivery to nearly any isotope resulting in
compounds with excellent activity and tolerability. Our novel TAT
compounds, including actinium-225, lead-212 and others, have
demonstrated this potential in pancreatic cancer, triple-negative
breast cancer and other types of tumor models which allows us to
deliver the optimal radioisotope based on tumor biology to maximize
outcomes. These data provide further evidence supporting the
continued development of CLR 121225, which is expected to enter a
Phase 1 first-in-human study later this year or early next
year.”
In preclinical studies, CLR 121225 demonstrated
potent anti-tumor activity in refractory pancreatic cancer mouse
xenograft models. A single administration at each dose level
(100nCi, 250nCi and 500nCi) resulted in tumor volume reduction in a
dose dependent manner with the highest dose providing near complete
eradication of the tumor. Additionally, it was shown that CLR
121225 demonstrated excellent biodistribution; approximately 15 –
20% of the infused drug accumulated in the tumor within four hours
and continued to accumulate over 72 – 96 hours. The mice had no end
organ toxicities demonstrating good tolerability. The data are
consistent with experiments using other alpha emitters conjugated
to the company’s proprietary PLE targeted delivery platform.
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
and www.wmclinicaltrial.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 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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