Full Press Release Details
a Research and Development Program Summary
macroglobulinemia pivotal trial topline data now expected second
half of 2023; pediatric high grade glioma trial to initiate in Q3
conjugate platform validation with alpha emitting
radioisotopes, small molecules, peptides and oligos
June 12, 2023 -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage biopharmaceutical company focused on the discovery,
development and commercialization of targeted treatments for cancer, today provided an update for its iopofosine I 131 clinical program
and guidance related to its Waldenstrom's macroglobulinemia (WM) CLOVER-WaM pivotal trial, as well as preclinical advancements to
its proprietary phospholipid ether drug conjugate platform.
WM CLOVER-WaM pivotal
The company now expects
to release top-line data from the WM CLOVER-WaM trial in the second half of 2023 and assuming NDA approval, remains on target for a 2024
product launch. Cellectar experienced delays with trial start-up activities, such as site contracting and country regulatory responses,
which slowed the initial pace of site initiations resulting in lower-than-expected patient enrollment. The company now has all 49 sites
up and running and patient enrollment rates have accelerated. As has been previously reported, and in agreement with the FDA, WM CLOVER-WaM
is a single arm, open label trial with a target enrollment of 50 patients.
disappointed with the delay in the study's completion, our ongoing commercial preparations have compressed timelines and support
a 2024 launch. Trial activations at high patient volume sites over recent quarters have increased the enrollment trend giving us confidence
in our ability to complete the WM CLOVER-WaM study in the second half of 2023," said Dr. Andrei Shustov, Cellectar's senior
vice president, medical. "Iopofosine I 131 demonstrated a 100% overall response rate, an 83.3% major response rate and a 16.7% complete
response rate in our Phase 2a study of six WM relapsed/refractory patients. In addition to these impressive response rates, iopofosine
I 131's fixed, short-duration therapy removes the need for the indefinite or prolonged maintenance treatment that is currently
required for other therapies."
pediatric high-grade gliomas
With the support of a
$2 million grant from the National Institute of Health's National Cancer Institute (NCI) the company plans to initiate a Phase 1b
study in pediatric high-grade gliomas (pHGGs) in the third quarter of 2023. The study objective is to identify the recommended iopofosine
I 131 Phase 2 dose in pHGG patients. The NCI grant was in part driven by the Phase 1a trial data demonstrating a near tripling of the
progression free survival typically observed in relapsed/refractory patients.
Central nervous system
ability to cross the blood-brain barrier and recently demonstrated activity in central nervous system lymphoma (CNSL) provides further
rationale for treatment of WM patients with CNSL involvement, also known as Bing-Neel syndrome.
Based upon achieving
a complete response in a CNSL patient treated as part of its Phase 2a trial, the company expanded the CNSL cohort to further evaluate
iopofosine I 131 in this indication. Currently, there are no approved therapies available to CNSL patients.
Iopofosine I 131 has
been evaluated in over 125 multiple myeloma patients including triple class refractory, quad/penta refractory, high-risk and post-BCMA
patients with response rates ranging from 40 to 62%. The company's recently published post BCMA response rate of 50% prompted expansion
of this cohort in our ongoing Phase 2a trial.
The company's COO, Jarrod Longcor, will deliver an oral presentation
of iopofosine I 131 in multiple myeloma at the Society of Nuclear Medicine and Molecular Imaging Annual Conference. The presentation is
on June 26th (#P1243, Using targeted radiotherapy in highly refractory multiple myeloma).
Phospholipid ether cancer targeting platform
Development of the company's
phospholipid ether cancer targeting platform continues to demonstrate its broad utility to provide targeted intracellular delivery of
multiple cancer treatment modalities. Preclinical data recently presented at several conferences demonstrate the broad utility of the
platform, including:
James Caruso, president
and CEO of Cellectar said, "The company's priority remains the near-term completion of our WM pivotal study. Iopofosine I 131's
Fast Track Designation allows for a six-month FDA review of our submission. In parallel, we continue to advance the clinical development
of iopofosine I 131 for both adult and pediatric indications while efficiently executing on potentially value-creating research to best
understand the wide-ranging capacity of our proprietary delivery platform."
About Cellectar Biosciences,
Cellectar Biosciences
is focused on the discovery and development of drugs for the treatment of cancer. The company is developing proprietary drugs 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 PDCs that specifically target cancer cells to deliver improved efficacy and better
safety as a result of fewer off-target effects. The company's PDC platform possesses the potential for the discovery and development
of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently and through research and development
The company's product
pipeline includes iopofosine, a small-molecule PDC designed to provide targeted delivery of iodine-131 (radioisotope), proprietary preclinical
PDC chemotherapeutic programs and multiple partnered PDC assets. The company is currently investigating iopofosine in a global, open-label,
pivotal expansion cohort in relapsed or refractory WM patients who have received at least two prior lines of therapy, including those
who have failed or had a suboptimal response to Bruton tyrosine kinase inhibitors. The WM cohort will enroll up to 50 patients to evaluate
the efficacy and safety of iopofosine for marketing approval. The company is also evaluating iopofosine in highly refractory multiple
myeloma patients in its Phase 2 CLOVER-1 study and relapsed/refractory pediatric cancer patients with sarcomas or brain tumors in the
Phase 1 CLOVER-2 study.
The Phase 1 pediatric
study is an open-label, sequential-group, dose-escalation study to evaluate the safety and tolerability of iopofosine in children and
adolescents with relapsed or refractory cancers, including malignant brain tumors, neuroblastoma, sarcomas, and lymphomas (including Hodgkin's
lymphoma). The Phase 1 study is being conducted internationally at seven leading pediatric cancer centers.
The company has established
exclusivity on a broad U.S. and international intellectual property rights portfolio around its proprietary cancer targeting PLE technology
platform, including iopofosine and its PDC programs.
In addition to the company's
exclusivity to iopofosine and its phospholipid ethers conjugated to small molecules, peptides, and oligos, the company now has non-exclusive
rights to the use of the phospholipid ether platform when conjugating with a chelator to bind select metal radioisotopes.
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.
Forward-Looking Statement
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 of the impact of the COVID-19 pandemic. 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. These forward-looking
statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.