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Celldex therapeutics Celldex Reports First Quarter 2021 Financial Results and Provides Corporate Update May 6 , 2021 HAMPTON , N.J. , May 06 , 2021 ( GLOBE NEWSWIRE ) -- Celldex Therapeutics , Inc. ( NASDAQ : CLDX ) today reported financial results for the first quarter ended March 31 , 2021 and provided a corporate update . " We are very encouraged by the recently reported positive interim results from our ongoing Phase 1b study of CDX - 0159 in chronic inducible urticaria . These data demonstrated an 80 % complete response rate and a well - tolerated safety profile , which we believe is a significant accomplishment in this complex disease setting with limited treatment options , " said Anthony Marucci , Co - founder , President and Chief Executive Officer of Celldex Therapeutics . " Based on these exciting results , we recently amended the protocol to add a third cohort in cholinergic urticaria , a debilitating disease affecting mainly young adults , where passive or active sweating induces hives and can severely impair their quality of life . We are nearing completion of patient dosing across both the cold induced and symptomatic dermographism cohorts from this study and look forward to presenting updated results from these cohorts this summer . " Mr. Marucci continued , " We are also making progress advancing our bispecific platform , presenting promising preclinical data at AACR that supports the development of clinical bispecific candidates that co - target ILT4 and PD- ( L ) 1 . We look forward to continuing these efforts while also exploring important targets controlling inflammation and auto - immune pathways . " Recent Pipeline Highlights CDX - 0159 - KIT Inhibitor Program 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 . KIT signaling controls the differentiation , tissue recruitment , survival and activity of mast cells . • Celldex initiated a Phase 1b open label study designed to evaluate the safety of a single dose ( 3.0 mg / kg ) of CDX - 0159 administered intravenously in December of 2020. Up to 20 patients with cold contact urticaria ( ColdU ; n = 10 ) or symptomatic dermographism ( SD ; n = 10 ) who are refractory to antihistamines are being enrolled . Patients ' symptoms are induced via provocation testing that resembles real life triggering situations . Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments , including changes from baseline provocation thresholds , measurement of tryptase and stem cell factor levels , clinical activity outcomes ( impact on urticaria symptoms , disease control , clinical response ) , quality of life assessments and measurement of tissue mast cells through skin biopsies . The study is being conducted by Dr. Marcus Maurer , Professor of Dermatology and Allergy at Charité - Universitätsmedizin in Berlin . Interim data from this study were reported in late March . Fifteen out of 20 planned patients with antihistamine refractory CIndU had received a single intravenous infusion of CDX - 0159 at 3 mg / kg , including nine patients with ColdU and six patients with SD . Safety results were reported for all 15 patients ; activity results were reported for all patients assessed for at least 15 days / 2 weeks after treatment ( n = 10 ; 7 ColdU and 3 SD ) . Patients had high disease activity as assessed by provocation threshold testing . • Eight of 10 patients , including all patients with ColdU , ( 7 ColdU ; 1 SD ) experienced a complete response ( CR ) as assessed by provocation threshold testing . One patient experienced a partial response ( PR ) . All patients will continue to be assessed for response through week 12. CDX - 0159 was generally well tolerated . • Enrollment is nearing completion in the ColdU and SD cohorts . Based on these compelling results , the study has been expanded to also include 10 patients with cholinergic urticaria and patient screening is expected to begin this month . • Updated results from additional patients with cold induced urticaria and symptomatic dermographism and long term follow up that continues to characterize magnitude and duration of treatment effect and their link to changes in tryptase levels are expected this summer . • Celldex initiated dosing in a Phase 1b multi - center study of CDX - 0159 in chronic spontaneous urticaria ( CSU ) in October . This study is a randomized , double - blind , placebo - controlled clinical trial designed to assess the safety of multiple ascending doses of CDX - 0159 in up to 40 patients with CSU who remain symptomatic despite treatment with antihistamines . Secondary and exploratory objectives include pharmacokinetic and pharmacodynamic assessments , including measurement of tryptase and stem cell factor levels and clinical activity outcomes ( impact on urticaria symptoms , disease control , clinical response ) as well as quality of life assessments . Results from the study are expected by the end of