Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients with Chronic Inducible Urticaria
July 21 2022 - 08:00AM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
first patient has been dosed in a Phase 2 clinical study of
barzolvolimab for the treatment of the two most common forms of
chronic inducible urticaria (CIndU) - cold urticaria (ColdU) and
symptomatic dermographism (SD). Barzolvolimab is a humanized
monoclonal antibody that specifically binds the receptor tyrosine
kinase KIT with high specificity and potently inhibits its
activity. CIndU is characterized by the occurrence of hives or
wheals that have an attributable trigger associated with them.
ColdU symptoms include itching, burning wheals and angioedema when
skin is exposed to temperatures below skin temperature. SD symptoms
include the development of wheals and a flare reaction in response
to stroking, scratching or rubbing of the skin.
"We are pleased that dosing has begun in this Phase 2 trial,
which brings us a step closer to delivering a new treatment option
to patients worldwide suffering with chronic inducible urticaria,"
said Diane C. Young, M.D., Senior Vice President and Chief Medical
Officer of Celldex Therapeutics. "Our previously reported Phase 1b
data in cold urticaria and symptomatic dermographism patients
demonstrated unprecedented results and we believe barzolvolimab
could potentially provide meaningful change to the treatment
paradigm for patients living with these severe diseases."
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 CIndU who
remain symptomatic despite antihistamine therapy, to determine the
optimal dosing strategy. Approximately 180 patients in 2 cohorts
(differentiated by CIndU subtype) including 90 patients with ColdU
and 90 patients with SD will be randomly assigned on a 1:1:1 ratio
to receive subcutaneous injections of barzolvolimab at 150 mg every
4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment
phase. Patients will then enter a follow-up phase for an additional
24 weeks. The primary endpoint of the study is the percentage of
patients with a negative provocation test at Week 12 (using
TempTest® for ColdU and FricTest® for SD). Secondary endpoints
include safety and other assessments of clinical activity including
CTT (critical temperature threshold), CFT (critical friction
threshold) and WI-NRS (worst itch numeric rating scale).
For additional information on this trial (NCT05405660), please
visit www.clinicaltrials.gov.
About Chronic Inducible Urticaria (CIndU)CIndU
is characterized by the occurrence of hives or wheals that have an
attributable trigger associated with them. ColdU symptoms include
itching, burning wheals and angioedema when skin is exposed to
temperatures below skin temperature. SD symptoms include the
development of wheals and a flare reaction in response to stroking,
scratching or rubbing of the skin. Approximately 0.5% of the total
population suffers from chronic inducible urticarias. Celldex is
exploring two subtypes, ColdU and SD. There are currently no
approved therapies for chronic inducible urticarias other than
antihistamines and patients attempt to manage symptoms associated
with their disease through avoidance of triggers.
About BarzolvolimabBarzolvolimab (also referred
to as CDX-0159) is a humanized monoclonal antibody that
specifically binds the receptor tyrosine kinase KIT with high
specificity and potently inhibits its activity. KIT is expressed in
a variety of cells, including mast cells, which mediate
inflammatory responses such as hypersensitivity and allergic
reactions. KIT signaling controls the differentiation, tissue
recruitment, survival and activity of mast cells. In certain
inflammatory diseases, such as chronic urticaria, mast cell
activation plays a central role in the onset and progression of the
disease.
About Celldex Therapeutics, Inc.Celldex is a
clinical stage biotechnology company dedicated to developing
monoclonal and bispecific antibodies that address devastating
diseases for which available treatments are inadequate. 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
inflammatory diseases and many forms of cancer. Visit
www.celldex.com.
Forward Looking Statement This 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.
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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
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Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & Administration(508)
864-8337scavanaugh@celldex.com
Patrick TillSenior Director, Investor Relations & Corporate
Communications(484) 788-8560ptill@celldex.com
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