Cellectar Biosciences and NorthStar Medical Radioisotopes Announce Partnership for Supply of Actinium-225
15 November 2024 - 12:05AM
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 the signing of a strategic supply agreement with
NorthStar Medical Radioisotopes, LLC, for the procurement of
NorthStar’s non-carrier added (n.c.a.) Ac-225. The Company’s CLR
121225 development program combines its proprietary Phospholipid
Ether (PLE) delivery platform and actinium 225 for the treatment of
solid tumors.
Existing supply chains for medical radioisotopes are often
strained, posing a challenge to patient care, clinical trials, and
ongoing drug development. Actinium-225 (Ac-225) is considered a
rare radioisotope and is in short supply for clinical development
and commercialization.
“Our PLE platform provides a unique ability to optimize delivery
of any radioisotope and can be designed for the treatment of
specific tumor types. Our leading alpha emitter program, CLR
121225, utilizes Ac-225 and has demonstrated promising preclinical
results in pancreatic, triple negative breast and other solid
tumors, justifying the progression to clinical development,” said
James Caruso, president and CEO of Cellectar. “We plan to advance
CLR 121225 into human clinical trials in 2025 as part of a broader
strategy to bring first-and best-in-class radiotherapeutics to
market. This agreement with NorthStar provides a reliable source of
Ac-225, which is a critical to our clinical development
strategy.”
NorthStar is a global innovator in the development, production,
and commercialization of radiopharmaceuticals used for therapeutic
applications and medical imaging including non-carrier added
(n.c.a) Ac-225.
“Recent years have seen increased interest in alpha-emitting
radiotherapies like Cellectar’s novel TAT compounds, including CLR
121225 and others, but development activities have been hampered by
the relative scarcity of Ac-225 supply,” said Frank Scholz,
president and CEO of NorthStar. “Our passion is to reduce
technological and operational barriers to give companies like
Cellectar a reliable source of environmentally preferred, high
purity (n.c.a) Ac-225 that will help make these new therapies
possible.”
The agreement provides supply of Ac-225 from NorthStar for 10
years, and initiation is expected to occur in 2025.
CLR 121225 is an investigational therapy and not yet approved by
any regulatory authority.
About NorthStar Medical Radioisotopes, LLC
(NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage
radiopharmaceutical company at the forefront of advancing patient
care by utilizing novel technologies to produce commercial-scale
radioisotopes that, once attached to a molecule, have the ability
to detect and treat cancer and other serious diseases. NorthStar’s
expanding industry-leading position in the emerging field of
radiopharmaceutical therapy is supported by its unique capabilities
in the sophisticated production of radioisotopes, proven management
team, and state-of-the-art, environmentally preferable
technologies. NorthStar routinely produces copper-67 (Cu-67) and is
poised to be the first commercial-scale producer of
non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s
Radiopharmaceutical Contract Development and Manufacturing
Organization (CDMO) services unit provides customized service
offerings and specialized radiopharmaceutical expertise to help
biopharmaceutical companies rapidly advance their development and
commercial programs. For more information about NorthStar’s
comprehensive portfolio and patient-focused services, visit:
www.northstarnm.com.
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical
company focused on the discovery, development and commercialization
of novel 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 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 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/A for the year ended
December 31, 2023, and our Form 10-Q for the quarter ended June 30,
2024. 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: Christy MaginnBliss Bio Health 703-297-7194
cmaginn@blissbiohealth.com
INVESTORS:Anne Marie FieldsPrecision AQ (formerly Stern
IR)annemarie.fields@precisionaq.com
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