Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria
June 21 2022 - 8:00AM
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 chronic spontaneous urticaria
(CSU). Barzolvolimab is a humanized monoclonal antibody that
specifically binds the receptor tyrosine kinase KIT with high
specificity and potently inhibits its activity. CSU is
characterized by the occurrence of hives or wheals for 6 weeks or
longer without identifiable specific triggers or causes. The
activation of the mast cells in the skin results in episodes of
itchy hives, swelling and inflammation of the skin that can go on
for years or even decades.
“We are excited to advance barzolvolimab into Phase 2 as we
believe it can produce potentially transformative therapeutic
activity against CSU and other mast cell driven diseases,” said
Diane C. Young, M.D, Senior Vice President and Chief Medical
Officer of Celldex Therapeutics. “The initiation of this study
marks an important milestone for Celldex and for the patients we
aim to benefit. CSU is an often serious and debilitating disease
with significant impacts on patient quality of life, and there is a
high unmet need for new treatment options.”
Dr. Young continued, “This CSU study is part of our chronic
urticaria program, where we are also moving forward with a second
Phase 2 trial in chronic inducible urticaria, which is expected to
initiate dosing shortly.”
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. Approximately 168 patients will be
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 phase. Patients will then enter a
36-week active treatment phase, in which patients not already
randomized to barzolvolimab at 150 mg every 4 weeks or 300 mg every
8 weeks will be randomized 1:1 to receive one of these two dose
regimens; patients already randomized to these treatment arms will
remain on the same regimen as during the placebo-controlled
treatment phase. Following the treatment period, patients will
enter a 24-week follow up phase. The primary endpoint of the study
is mean change in baseline to Week 12 in UAS7. Secondary endpoints
include other assessments of safety and clinical activity including
ISS7, HSS7 and AAS7.
For additional information on this trial (NCT05368285), please
visit www.clinicaltrials.gov.
About Chronic Spontaneous Urticaria (CSU)CSU is
characterized by the occurrence of hives or wheals for 6 weeks or
longer without identifiable specific triggers or causes. The
activation of the mast cells in the skin (release of histamines,
leukotrienes, chemokines) results in episodes of itchy hives,
swelling and inflammation of the skin that can go on for years or
even decades. Current therapies provide symptomatic relief only in
some patients.
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.
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 TillSenior Director, Investor Relations & Corporate
Communications(484) 788-8560ptill@celldex.com
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Aug 2024 to Sep 2024
Celldex Therapeutics (NASDAQ:CLDX)
Historical Stock Chart
From Sep 2023 to Sep 2024