Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical
biopharmaceutical company focused on the discovery, development and
commercialization of targeted drugs for the treatment of cancer,
announced today a partnership to advance the treatment of
Waldenstrom's macroglobulinemia (WM) in the community setting with
American Oncology Network (AON), a leading oncology platform with
an innovative model of physician-led, community-based oncology
management, and its data arm subsidiary Meaningful Insights-BioTech
Analytics (MiBA), a healthcare AI technology company on a mission
to close the feedback loop between physicians, patients, and
industry partners.
"AON is currently managing over 650
Waldenstrom’s macroglobulinemia patients,” said Dr. Fred Divers,
chief medical officer of AON. “We are committed to providing
promising new radiotherapies, starting with Cellectar’s iopofosine
I 131, a novel phospholipid radiotherapeutic conjugate, throughout
our nationwide network of clinics. It is critical for patients to
have access to advances in the treatment of this rare cancer, where
there is currently no standard of care for those with relapsed or
refractory disease. The pivotal topline data for iopofosine
demonstrating an overall response rate of 76.5% and 100% disease
control rate utilizing a four dose fixed course of therapy in a
heavily pretreated relapse/refractory WM patient population is very
compelling when compared to response rates of other therapeutic
options in this setting.”
Positive topline data from the pivotal Clover WaM
study for iopofosine I 131 was reported on January 8,
achieving the primary endpoint with a 61% major response rate (MRR)
and exceeding the protocol statistical hurdle of 20%. This was the
largest study to date in relapsed or refractory WM patients
post-BTKi therapy and represents the most refractory population
ever tested in clinical studies based upon a review of published
literature. Iopofosine I 131 was well tolerated and its toxicity
profile was consistent with the Company's previously reported
safety data.
“We are extremely pleased to be partnering with
AON and MiBA to support our collective goal to enrich the WM
treatment paradigm for patients and providers,” said James Caruso,
president and CEO of Cellectar. “This collaboration will provide
additional insight to patients’ and health care providers’ needs
across the WM treatment landscape and the learnings will be
incorporated into the launch strategy for iopofosine I 131.
Following achievement of the primary endpoint in the CLOVER WaM
pivotal study, this partnership with AON represents another
strategically important collaboration to ensure patient access and
optimize outcomes with iopofosine therapy upon FDA approval.”
AON is one of the fastest growing networks of
community oncology practices with 85 sites of care across the U.S.
focused on delivering high-quality cancer care. The partnership
with AON and MiBA is a key addition to Cellectar’s planned
collaborations with leading U.S. community-based cancer care
networks to identify unmet WM patient needs and opportunities to
optimize the potential commercial launch for iopofosine I 131.
“We are very excited to be able to support the
efforts of all involved in this project with MiBA’s technical and
analytical capabilities,” said Mark Moch, Executive Manager at
MiBA. “Data identification, curation and advanced analytics are
essential in moving treatments forward. Keeping our patient at the
center and working in close association with AON and Cellectar,
gives us the ability to positively affect outcomes and contribute
to future standards of care.”
The U.S. Food and Drug Administration (FDA) has
granted Cellectar’s iopofosine I 131, a small-molecule Phospholipid
Drug Conjugate™ (PDC) designed to provide targeted delivery of
iodine-131 (radioisotope), Orphan and Fast Track Designation for
relapsed/refractory WM patients.
WM is a rare type of B-cell lymphoma that
originates from the bone marrow lymphocytes. It is estimated that
26,000 people are living with WM in the U.S. and greater than
10,000 are in a second-line plus stage of treatment. Currently
there are limited treatment options with only one approved class of
drugs and no established standard of care beyond second-line
therapy.
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 American Oncology
NetworkSince its inception in 2018, American Oncology
Network, Inc. (Nasdaq: AONC) has offered an innovative model of
physician-led, community-based oncology management. AONC preserves
and elevates community oncology by helping its physicians navigate
the complex healthcare landscape, providing them an efficient
platform to work autonomously and thrive, and most importantly,
improving the quality of patient care that is being delivered. The
network is an alliance of physicians and veteran healthcare leaders
partnering to ensure the long-term success and viability of
oncology diagnosis and treatment in community-based settings. As of
September 30, 2023, AONC has more than 200 providers across 85
locations in 19 states and the District of Columbia. AONC’s robust
platform provides oncology practices with comprehensive support,
access to revenue- diversifying adjacent services and practice
management expertise to empower physicians to make cancer care
better for every patient.
About MiBAMiBA is a healthcare AI
technology company on a mission to close the feedback loop between
physicians, patients and industry partners. The technology and data
insights that MiBA generates will support pharmaceutical companies,
research organizations, payers, biotech, health systems and
providers to advance the quality of patient care.
MiBA’s culture is one of empathy. The heart of the
mission is every patient deserves the best care possible- period.
Putting the power of data into the hands of industry stakeholders
to enable to drive informed decisions.
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
American Oncology Network (NASDAQ:AONC)
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