Celldex Doses First Patient in Phase 1b Study of CDX-0159 in Chronic Inducible Urticaria
December 09 2020 - 8:01AM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that the
first patient has been dosed in its open label clinical trial in
cold contact urticaria and symptomatic dermographism, the two most
common forms of chronic inducible urticaria (CIndU). CDX-0159 is a
humanized monoclonal antibody developed by Celldex that binds the
KIT receptor with high specificity and potently inhibits its
activity. The KIT receptor tyrosine kinase 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. As previously presented,
CDX-0159 demonstrated a favorable safety profile as well as
profound and durable reductions of plasma tryptase, indicative of
systemic mast cell ablation in a Phase 1a single dose, healthy
volunteer study. In October, Celldex also announced the initiation
of a Phase 1b study in chronic spontaneous urticaria.
“Inducible urticarias can significantly impact a patient’s
quality of life, including insomnia, lack of energy, poor
self-image, social withdrawal and depression,” said Dr. Marcus
Maurer, Professor of Dermatology and Allergy and Director of
Research at the Department of Dermatology and Allergy at the
Allergie-Centrum-Charité of the Charité - Universitätsmedizin in
Berlin and the lead investigator for the study. “This is especially
true for cold contact urticaria and symptomatic dermographism as
avoiding the triggers for these diseases is extremely difficult and
therapies that address the root cause of disease—mast cell
activation—are sorely needed. We look forward to completing this
study and believe CDX-0159 could be a much needed disease-modifying
drug for these patients.”
“With the initiation of our second study in urticaria, Celldex
has laid an exciting foundation for the CDX-0159 program,” said
Diane C. Young, MD, Senior Vice President and Chief Medical Officer
of Celldex Therapeutics. “The CIndU study should provide rapid
clinical proof of concept in a disease setting that is clearly
driven by mast cells. In addition to continuing to assess the
safety and potential clinical benefit of CDX-0159, we also hope to
confirm its impact on mast cells through the collection and
analysis of serial skin biopsies, answering an important question
about CDX-0159’s mechanism of action.”
The Phase 1b study is an open label clinical trial designed to
evaluate the safety of a single dose of CDX-0159 in up to 20
patients with cold contact urticaria (n=10) or symptomatic
dermographism (n=10) who are refractory to antihistamines.
Patients' symptoms will be induced via provocation testing that
resembles real life triggering situations. Secondary and
exploratory objectives include pharmacokinetic and pharmacodynamic
assessments, including changes from baseline provocation
thresholds, measurement of tryptase and stem cell factor levels,
clinical activity outcomes (impact on urticaria symptoms, disease
control, clinical response), quality of life assessments and
measurement of tissue mast cells through skin biopsies. CDX-0159
will be administered intravenously (3.0 mg/kg) as add on treatment
to H1-antihistamines. More information about this study is
available on www.clinicaltrials.gov (Identifier: NCT04548869).
Initial data from the study are expected at the end of the first
quarter of 2021.
CIndUs are forms of urticaria that have an attributable cause or
trigger associated with them, typically resulting in hives or
wheals. Approximately 0.5% of the total population suffers from
inducible urticarias. Celldex is exploring the two most common
forms, cold-induced and dermographism (scratch-induced)
urticarias. People afflicted with cold induced urticaria
experience symptoms like itching, burning wheals and angioedema
where their skin comes in contact with temperatures below skin
temperature. Symptomatic dermographism is characterized by the
development of a wheal and flare reaction in response to a
stroking, scratching or rubbing of the skin, usually occurring
within minutes of the inciting stimulus. For both of these
diseases, mast cell activation leading to release of soluble
mediators is thought to be the driving mechanism leading to the
wheals and other symptoms. There are currently no approved
therapies for CIndUs and patients attempt to manage symptoms
associated with their disease through avoidance of triggers and the
use of antihistamines. Celldex believes that CDX-0159 has
significant potential to directly inhibit and/or ablate mast cells
which, in turn, could be disease modifying for patients.
About CDX-0159CDX-0159 is a
monoclonal antibody that binds the KIT receptor with high
specificity and potently inhibits its activity. The KIT receptor
tyrosine kinase 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. Celldex is currently studying CDX-0159 in chronic
urticarias. Currently approved therapies for chronic urticarias
target symptomatic relief. Celldex believes that CDX-0159 has
significant potential to interfere with mast cells at multiple
steps upstream of current treatments, which, in turn, could be
disease modifying for patients. In addition, Celldex is also
evaluating additional opportunities in other mast cell driven
diseases where CDX-0159’s potency and high specificity for KIT
could be important.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
effect critical pathways to improve the lives of patients with
inflammatory diseases and many forms of cancer.
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Company ContactSarah CavanaughSenior Vice
President, Corporate Affairs & AdministrationCelldex
Therapeutics, Inc.(781) 433-3161scavanaugh@celldex.com
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