Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive
12 week results from the Company’s Phase 2 clinical trial of
barzolvolimab in patients with moderate to severe chronic
spontaneous urticaria (CSU) refractory to antihistamines, including
patients with biologic-refractory disease. The studies will
continue dosing patients until week 52. Barzolvolimab is a
humanized monoclonal antibody that specifically binds the receptor
tyrosine kinase KIT with high specificity and potently inhibits its
activity, which is required for mast cell function and survival.
CSU is characterized by the occurrence of hives or wheals for 6
weeks or longer without identifiable specific triggers or causes.
Treatment options for patients with CSU are limited and there are
no approved therapies for patients who are not adequately
controlled by omalizumab. The data were presented by Dr. Marcus
Maurer, Professor of Dermatology and Allergy at Charité –
Universitätsmedizin in Berlin, in a late breaking oral presentation
(L18) as part of the American Academy of Allergy, Asthma &
Immunology (AAAAI) Annual Meeting 2024.
“These data continue to support barzolvolimab’s potential to
bring meaningful improvements to patients suffering from this often
very severe and debilitating disease,” said Marcus Maurer,
M.D. “The novel mast cell depleting mechanism of barzolvolimab
addresses the root driver of chronic spontaneous urticaria
providing early, durable and, most importantly, the opportunity for
complete disease control for patients who are not seeing meaningful
benefits from the current standard of care, including patients with
omalizumab refractory disease.”
“We are thrilled to share these positive results, which we
believe further establish barzolvolimab as a potential
transformative treatment option for patients suffering with CSU,
and are actively planning for the initiation of our Phase 3 program
in CSU this summer,” commented Anthony S. Marucci, President and
Chief Executive Officer of Celldex Therapeutics. “We also thank the
patients and investigators for their participation in this study
and look forward to reporting 52 week data later this year.”
Data from the 208 patients randomized in the study showed that
barzolvolimab achieved the primary efficacy endpoint, with a
statistically significant mean change from baseline to week 12 in
UAS7 (weekly urticaria activity score) compared to placebo at all
dose levels. Secondary and exploratory endpoints in the study were
also achieved at week 12 and strongly support the primary endpoint
results, including changes in ISS7 (weekly itch severity score) and
HSS7 (weekly hives severity score) and responder analyses.
Importantly, barzolvolimab demonstrated rapid, durable and
clinically meaningful responses in patients with moderate to severe
CSU refractory to antihistamines, including patients with prior
omalizumab treatment. Demographics and baseline disease
characteristics were well balanced across treatment groups. The
majority of patients on study had severe disease (UAS7≥28).
Summary of Clinical Activity Assessments at Week
12 |
|
300 mg Q8W(n=51) |
150 mg Q4W(n=52) |
75 mg Q4W(n=53) |
Placebo(n=51) |
UAS7 Changes |
Baseline UAS7 (mean) |
31.33 |
30.75 |
30.30 |
30.09 |
LS Mean change at Week 12 |
-23.87 |
-23.02 |
-17.06 |
-10.47 |
LS Mean difference from placebo (Confidence Interval, p value) |
-13.41 (CI: -17.47, -9.34)p<0.0001 |
-12.55(CI:-16.56, -8.55)p<0.0001 |
-6.60(CI:-10.71, -2.49)p=0.0017 |
|
HSS7 Changes |
|
|
|
|
Baseline HSS7 (mean) |
14.92 |
15.05 |
14.86 |
14.47 |
LS Mean change at Week 12 |
-12.19 |
-11.19 |
-8.25 |
-4.95 |
LS Mean difference from placebo (Confidence Interval, p value) |
-7.24(CI:-9.36, -5.12)p<0.0001 |
-6.24 (CI:-8.33, -4.16),p<0.0001 |
-3.31 (CI:-5.40, -1.22),p=0.0020 |
|
ISS7 Changes |
|
|
|
|
Baseline ISS7 (mean) |
16.42 |
15.70 |
15.44 |
15.61 |
LS Mean change at Week 12 |
-11.79 |
-11.68 |
-8.62 |
-5.47 |
LS Mean difference from placebo (Confidence Interval, p value) |
-6.32 (CI: -8.50, -4.13),p<0.0001 |
-6.21 (CI: -8.38, -4.04),p<0.0001 |
-3.16 (CI: -5.41, -0.91),p=0.0061 |
|
Responder Analyses/Clinical Responses |
UAS7=0 (Complete Control) |
37.5% |
51.1% |
22.9% |
6.4% |
UAS7≤6 (Well-controlled) |
62.5% |
59.6% |
41.7% |
12.8% |
UAS7, HSS7 and ISS7 data were analyzed using ANCOVA model and
multiple imputation.
Barzolvolimab demonstrated strong improvement in UAS7
independent of omalizumab status at Week 12. Approximately 20%
(n=41) of enrolled patients received prior treatment with
omalizumab and more than half of these patients had
omalizumab-refractory disease. These patients experienced a similar
clinical benefit as the overall treated population within their
individual dosing groups consistent with the barzolvolimab
mechanism of action.
Barzolvolimab was well tolerated with a favorable safety
profile. Most adverse events were mild to moderate in severity;
through 12 weeks, the most common treatment emergent adverse events
in barzolvolimab treated patients were urticaria/CSU (10%), hair
color changes (9%), and neutropenia/ANC decrease (8%). The rate of
infections was similar between barzolvolimab treated patients and
placebo with no association between neutropenia and infections.
Phase 2 Study Design The randomized,
double-blind, placebo-controlled, parallel group Phase 2 study is
evaluating the efficacy and safety profile of multiple dose
regimens of barzolvolimab in patients with CSU who remain
symptomatic despite antihistamine therapy, to determine the optimal
dosing strategy. 208 patients were randomly assigned on a 1:1:1:1
ratio to receive subcutaneous injections of barzolvolimab at 75 mg
every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or
placebo during a 16-week placebo-controlled treatment period. After
16 weeks, patients then enter a 36-week active treatment period, in
which patients receiving placebo or the 75 mg dose are randomized
to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8
weeks; patients already randomized to the 150 mg and 300 mg
treatment arms remain on the same regimen as during the
placebo-controlled treatment period. After 52 weeks, patients then
enter a follow-up period for an additional 24 weeks. The primary
endpoint of the study is mean change in baseline to Week 12 in UAS7
(weekly activity score). Secondary endpoints include other
assessments of safety and clinical activity including ISS7 (weekly
itch severity score), HSS7 (weekly hives severity score) and AAS7
(weekly angioedema activity score).
For additional information on this trial (NCT05368285), please
visit www.clinicaltrials.gov
Webcast The Company will host a conference
call/webcast tomorrow to discuss the results at 9:45 a.m. ET.
Management will be joined by Dr. Marcus Maurer and by Dr. Allen
Kaplan, both broadly recognized as preeminent experts in the field
of allergy and, specifically in chronic urticaria. The event will
be webcast live and can be accessed by going to the "Events &
Presentations" page under the "Investors & Media" section of
the Celldex Therapeutics website at www.celldex.com.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company leading the science at the
intersection of mast cell biology and the development of
transformative therapeutics for patients. Our pipeline includes
antibody-based therapeutics which have the ability to engage the
human immune system and/or directly affect critical pathways to
improve the lives of patients with severe inflammatory, allergic,
autoimmune and other devastating diseases. Visit
www.celldex.com.
Forward Looking StatementThis release contains
"forward-looking statements" made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
These statements are typically preceded by words such as
"believes," "expects," "anticipates," "intends," "will," "may,"
"should," or similar expressions. These forward-looking statements
reflect management's current knowledge, assumptions, judgment and
expectations regarding future performance or events. Although
management believes that the expectations reflected in such
statements are reasonable, they give no assurance that such
expectations will prove to be correct or that those goals will be
achieved, and you should be aware that actual results could differ
materially from those contained in the forward-looking statements.
Forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, our ability to
successfully complete research and further development and
commercialization of Company drug candidates, including
barzolvolimab (also referred to as CDX-0159), in current or future
indications; the uncertainties inherent in clinical testing and
accruing patients for clinical trials; our limited experience in
bringing programs through Phase 3 clinical trials; our ability to
manage and successfully complete multiple clinical trials and the
research and development efforts for our multiple products at
varying stages of development; the effects of the outbreak of
COVID-19 on our business and results of operations; the
availability, cost, delivery and quality of clinical materials
produced by our own manufacturing facility or supplied by contract
manufacturers, who may be our sole source of supply; the timing,
cost and uncertainty of obtaining regulatory approvals; the failure
of the market for the Company's programs to continue to develop;
our ability to protect the Company's intellectual property; the
loss of any executive officers or key personnel or consultants;
competition; changes in the regulatory landscape or the imposition
of regulations that affect the Company's products; our ability to
continue to obtain capital to meet our long-term liquidity needs on
acceptable terms, or at all, including the additional capital which
will be necessary to complete the clinical trials that we have
initiated or plan to initiate; and other factors listed under "Risk
Factors" in our annual report on Form 10-K and quarterly reports on
Form 10-Q.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillMeru Advisors(484)
788-8560ptill@meruadvisors.com
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