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 positive results from its CLOVER WaM pivotal study
evaluating iopofosine I 131, a potential first-in-class, targeted
radiotherapeutic candidate for the treatment of relapsed/refractory
Waldenstrom’s macroglobulinemia (WM) patients that received at
least two prior lines of therapy, including Bruton tyrosine kinase
inhibitors (BTKi’s). CLOVER WaM is the first and largest WM study
to date in a highly refractory patient population, including
patients who are refractory to all available treatment categories.
As of May 31, 2024, results in the CLOVER WaM
study (NCT02952508) had an overall response rate (ORR) of 80% and a
major response rate (MRR) of 56.4% (95% CI, 0.42 to 0.67), which
exceeded the agreed-upon primary endpoint of a 20% MRR. Median age
was 70 years (range, 50-88) in the modified intent to treat (mITT)
population (n=55). The median number of prior lines of therapy was
4 (range, 2-14), with approximately 27% of patients refractory to
all available therapies (BTKi, anti-CD20 antibody, chemotherapy),
and 40% of patients dual-class refractory (BTKi and rituximab).
Notably, comparable ORRs were observed across all clinically
challenging disease subgroups, including: MYD88-wt (81%; n=16),
P53-mutated (80%; n=5), and clinical patient cohorts including
post-BTKi (72%; n=39), as well as dual-class (59%; n=22), and
triple-class (53%; n=15) refractory patients.
“Treatment options for relapsed or refractory WM
patients are limited with a critical need for new therapies with
novel mechanisms of action. Currently, only about 10% of patients
receiving salvage therapy respond to that treatment and experience
limited durability of less than six months in later lines of
therapy,” said Sikander Ailawadhi, M.D., professor of medicine at
Mayo Clinic, and lead investigator in the CLOVER WaM study. “The
98% disease control rate and 80% ORR achieved in this pivotal study
utilizing just four doses of iopofosine monotherapy in multi-class
refractory patients are very compelling, demonstrating impressive
deep and durable responses with a high proportion of patients
remaining treatment-free.”
Secondary endpoints of disease control rate
(98.2%) and duration of response (DoR) presented evidence that
iopofosine provided durable clinical benefit across all response
categories. The median DoR in patients achieving major response and
overall response were not reached as of the data cutoff, with 78%
and 72% of patients remaining free from disease progression at 18
months, respectively.
“The outcomes observed in this study continue to
far exceed expectations and provide evidence of the potential for
iopofosine in a broad range of WM patients, including
difficult-to-treat subgroups. We believe with these results that
iopofosine I 131 has the potential to become the standard-of-care
therapy for relapsed/refractory patients,” said James Caruso,
president and CEO of Cellectar. “It is our commitment to ensure
that iopofosine will be made available to patients awaiting a
meaningful new treatment option. To this end, we plan to submit our
NDA in the fourth quarter of 2024 and will be seeking priority
review, which provides an estimated six-month regulatory review
period.”
Iopofosine I 131 was well tolerated and its
toxicity profile was consistent with the company's previously
reported safety data. Importantly, and unlike other cancer
therapies, patients on iopofosine did not experience any
cardiovascular, renal, or liver toxicities, and no peripheral
neuropathy or significant bleeding. The safety profile was
consistent with selective targeting of tumor sites with clinically
negligible off-target effect outside the hematologic system. The
most commonly reported treatment emergent adverse events were
hematologic in nature (thrombocytopenia, neutropenia and anemia)
and were predictable and manageable. All patients recovered from
cytopenias within a few weeks post nadir.
*Iopofosine I 131 is an investigational agent and
has not been approved for use in any country, for any
indication.
Conference Call & Webcast
The company will host an event on July 24, 2024, at 8:00 a.m., EDT,
to provide a comprehensive overview of the CLOVER WaM study data,
the current WM treatment landscape, unmet needs for patients with
this disease, and opportunities to improve patient outcomes.
The event will feature both company leadership and
key investigators. Details are as follows:
Conference Call
DetailsDate: July 24,
2024Time: 8:00 a.m. EDT/ 5:00 a.m. PDT
Dial-in number:
1-800-717-1738Webcast link: click HERE
A replay of the conference call will be available
on the Events section of the company’s investor relations
website.
About Waldenstrom’s
MacroglobulinemiaWM 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 11,500 patients require treatment in the
relapsed or refractory setting and there are an estimated 4,700
patients requiring 3rd line or greater therapy. There are
approximately 1,000 patients that have exhausted all current
treatment options by 3rd line because they are ineligible or
intolerant to those existing therapies. Therefore, the total
addressable market for 3rd line or greater therapy is approximately
5,700 patients. 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
because greater than 50% of patients are treated with the same or
similar treatment from prior lines of therapy. Greater than 60% of
treatments utilized are non-FDA approved therapies. 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.
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 or join the conversation by
liking and following us on the company’s social media
channels: Twitter, LinkedIn, and Facebook.
Forward-Looking Statement
DisclaimerThis 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’s review process and
view of our data, 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, 2023, and our Form 10-Q for
the quarter ended March 31, 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:Claire LaCagninaBliss Bio
Health315-765-1462clacagnina@blissbiohealth.com
INVESTORS:Chad KoleanChief Financial
Officerinvestors@cellectar.com
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