Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis
06 7월 2023 - 9:01PM
Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the
first patient has been dosed in the Company’s Phase 2 subcutaneous
study of barzolvolimab in eosinophilic esophagitis (EoE). EoE is
the most common type of eosinophilic gastrointestinal disease, a
chronic inflammatory disease of the esophagus. Several studies have
suggested that mast cells may be an important driver in this
disease. 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 the function and survival of the mast cell.
“There is a growing body of literature that suggests that
eosinophilic esophagitis may be a misnomer for this difficult to
treat disease and that other cell types, including mast cells, may
play an important role in the disease process,” said Diane C.
Young, M.D, Senior Vice President and Chief Medical Officer of
Celldex Therapeutics. “This is further supported by the finding
that mast cells are present in the biopsy tissue of some patients
who continue to suffer from EoE even after eosinophils have been
fully depleted. We look forward to exploring the role of our mast
cell depleting agent, barzolvolimab, in this setting and believe
learnings from this study may inform expanded development into
other GI disorders in the future.”
The randomized, double-blind, placebo-controlled, parallel group
Phase 2 study is evaluating the efficacy and safety profile of
subcutaneous barzolvolimab in patients with active EoE.
Approximately 60 patients will be randomly assigned on a 1:1 ratio
to receive subcutaneous injections of barzolvolimab at 300 mg every
8 weeks or placebo during a 16-week placebo-controlled treatment
phase. Patients then enter a 12-week active treatment phase, in
which all patients will receive barzolvolimab 300 mg every 8 weeks.
Patients then enter a follow-up phase for an additional 16 weeks.
The primary endpoint of the study is reducing esophageal
intraepithelial infiltration of mast cells as assessed by peak
esophageal intraepithelial mast cell count. Secondary endpoints
include the reduction of symptoms of dysphagia and esophageal
intraepithelial infiltration of eosinophils and safety. When all
clinical trial sites are open, the study will include approximately
60 clinical trial centers across 8 countries, including the United
States.
EoE, the most common type of eosinophilic gastrointestinal
disease, is a chronic inflammatory disease of the esophagus
characterized by the infiltration of eosinophils. This chronic
inflammation can result in trouble swallowing, chest pain, vomiting
and impaction of food in the esophagus – a medical emergency.
Currently, there are limited treatment options for
EoE. Several studies have suggested that mast cells may be an
important driver in the disease. Given the lack of effective
therapies for EoE and barzolvolimab’s potential as a mast cell
depleting agent, Celldex believes EoE is an important indication
for study. For additional information on this trial (NCT05774184),
please visit www.clinicaltrials.gov.
About BarzolvolimabBarzolvolimab is a humanized
monoclonal antibody that 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 TillMeru Advisors(484)
788-8560ptill@meruadvisors.com
Celldex Therapeutics (NASDAQ:CLDX)
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