Celldex Therapeutics Presents Positive Interim Data from Barzolvolimab Phase 1b Study in Chronic Spontaneous Urticaria at EAACI 2022

-Rapid, profound and durable responses across multiple dosing groups with favorable safety profile-
-Mean reduction from baseline in urticaria activity (UAS7) of 66.6% in 1.5 mg/kg dose group at week 12 and 75.1% at week 8 in the 3 mg/kg dose group (reflects one dose; ongoing)-
-Complete response (UAS7=0) of 57.1% in 1.5 mg/kg dose group at week 12 and 44.4% at 8 weeks in 3 mg/kg dose group (reflects one dose; ongoing)-
-42% of patients treated with barzolvolimab had prior omalizumab and had similar symptom improvement as overall population-
-Company to host webcast conference call on Thursday, June 30 at 6:30 p.m. ET-

HAMPTON, N.J., June 30, 2022 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced interim data from the Company’s ongoing Phase 1b clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines. 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 mast cell function and survival. CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes.

Data show that multiple doses of barzolvolimab resulted in dose-dependent decreases in itch and hives, as measured through the urticaria activity score over 7 days (UAS7), with a mean UAS7 reduction of 66.6% in all patients in the 1.5 mg/kg dose group (n=8) at week 12 and 75.1% in all patients in the ongoing 3.0 mg/kg dose group (n=9) at week 8 (reflects one dose), demonstrating meaningful symptom improvements for patients. Complete response as measured by UAS7=0 was 57.1% for patients in the 1.5 mg/kg dose group at week 12 and 44.4% for the patients in the 3.0 mg/kg dose group at week 8 (reflects one dose; ongoing).

Importantly, administering multiple doses of barzolvolimab demonstrated a favorable safety profile, supporting Phase 2 clinical development. These data were presented by Dr. Marcus Maurer, Professor of Dermatology and Allergy at Charité – Universitätsmedizin in Berlin, as a late-breaking electronic poster presentation (#100097) as part of the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2022.