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Celldex Therapeutics Inc (NASDAQ: 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).
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- 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.
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New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.