Celldex Therapeutics to Expand Development of CDX-0159 into Prurigo Nodularis (PN)
February 22 2021 - 4:01PM
Celldex Therapeutics, Inc. (Nasdaq:CLDX) today announced that the
Company will expand clinical development of CDX-0159 into prurigo
nodularis (PN), a chronic skin disease characterized by the
development of hard, intensely itchy (pruritic) nodules on the
skin. Mast cells through their interactions with sensory neurons
and other immune cells are believed to play an important role in
amplifying chronic itch and neuroinflammation, both of which are a
hallmark of PN. 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.
In a Phase 1a single dose, healthy volunteer study, CDX-0159
demonstrated profound and durable reductions of plasma tryptase,
indicative of systemic mast cell suppression/ablation. Celldex is
evaluating CDX-0159 in two ongoing Phase 1b clinical trials in
patients with chronic spontaneous urticaria and chronic inducible
urticaria, both mast cell driven diseases. By exploring the
potential of CDX-0159 to suppress chronic itch and
neuroinflammation in PN, Celldex believes it may have the
opportunity to expand future development to also include other
chronic pruritic skin conditions and other medically significant
conditions driven by itch and neuroinflammation.
Diane C. Young, MD, Senior Vice President and Chief Medical
Officer of Celldex Therapeutics stated, “As we look to
expand our clinical development plan for CDX-0159, we are
considering a number of key factors, including the scientific
rationale, patient need, the market opportunity and the clinical
and regulatory path forward. We look forward to data this year from
ongoing trials in chronic urticarias, and results from these
studies will position us to evaluate expansion into other mast cell
driven diseases where we believe suppressing mast cells will
minimize patient symptoms. We have selected prurigo nodularis for
further study because emerging science suggests mast cell
activation plays an important role in amplifying a cascade of
mediators that drive itch signaling with associated
neuroinflammation. Here we aim to learn whether mast cell
suppression with CDX-0159 can impact this cascade to diminish itch
and allow for lesion healing. PN also offers an opportunity for an
early clinical signal and could bring a much-needed treatment to
patients while opening a door to development opportunities in other
significant conditions driven by itch and neuroinflammation.”
Individuals with PN develop multiple, sometimes hundreds, of
elevated, hard, nodular lesions on the skin. Patients experience
intense itch and other sensations such as stinging, burning and
pain which often leads to scratching to the point of bleeding and
increased pain. This scratching, in turn, causes more lesions to
develop, perpetuating the disease cycle. PN significantly impacts
quality of life, often leading to sleep disturbance, psychological
distress, social isolation, anxiety and depression. There are
currently no FDA approved therapies for PN, representing an area of
significant unmet need. Physicians typically attempt to address the
immunological or neural component of PN through the use of topical
therapies, which are not effective for many patients. While PN is
classified as a rare disease by some organizations, a report by
John Hopkins University1 suggests that prevalence of PN may be
substantially under-reported, in part because of other underlying
dermatologic or systemic conditions. Celldex anticipates initiating
the study in PN in the fourth quarter of 2021. Celldex continues to
assess potential opportunities for CDX-0159 in other diseases where
mast cells play an important role, such as dermatologic,
respiratory, allergic, gastrointestinal and ophthalmic
conditions.
1J Invest Dermatol, Feb 2020
About CDX-0159CDX-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. In a Phase 1a single dose, healthy
volunteer study, CDX-0159 demonstrated a favorable safety profile
as well as profound and durable reductions of plasma tryptase,
indicative of systemic mast cell suppression or ablation. Based on
this data, Celldex has initiated two Phase 1b studies in the mast
cell driven disease chronic spontaneous urticaria (CSU) and the two
most common forms of chronic inducible urticaria (CIndU)—cold
contact urticaria and symptomatic dermographism. The Company is
also planning a third study in prurigo nodularis (PN), where mast
cells through their interactions with sensory neurons and other
immune cells are believed to play an important role in amplifying
chronic itch and neuroinflammation in PN.
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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