Celldex Announces First Patient Dosed in Phase 2 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria

HAMPTON, NJ, USA I June 21, 2022 I 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 Barzolvolimab
Barzolvolimab (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.

SOURCE: Celldex Therapeutics

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