Celldex's CDX-0159 Shows 80% Response Rate In Early-Stage Skin Allergy Study

Celldex Therapeutics Inc CLDX has reported interim data from the ongoing Phase 1b trial, evaluating CDX-0159 in patients with antihistamine refractory cold contact urticaria (ColdU) and symptomatic dermographism (SD), the two most common forms of chronic inducible urticaria (CIndU).

• CIndU are forms of urticaria (red, itchy welts that result from a skin reaction) with an attributable cause or trigger associated with them, typically resulting in wheals (hives) angioedema.
• Eight out of ten patients treated and assessed for at least 15 days after treatment experienced a complete response (CR) to provocation testing post-treatment. One patient experienced a partial response (PR).
• Enrollment is near completion in the ColdU and SD cohorts, and now the study will be expanded to include ten patients with cholinergic urticaria.
• CDX-0159 was generally well tolerated. A single severe infusion reaction was observed (brief loss of consciousness, followed by shaking and sweating).
• The patient was treated with antihistamines and steroids; no epinephrine was administered, who recovered rapidly.
• No evidence of mast cell activation was observed shortly after the infusion and further at a later time point.
• Through day 15, three patients had transient, mild decreases in hemoglobin, and no patients had meaningful declines in white blood cells.
• CDX-0159 is a humanized monoclonal antibody that binds the KIT receptor with high specificity and potently inhibits its activity.
• The KIT receptor tyrosine kinase is expressed in various cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions.
• Celldex will host a conference call/webcast today at 7:45 a.m. ET.
• Price Action: CLDX shares are trading 1.47% lower at $23.4 in premarket trading on the last check Monday.