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Celldex therapeutics Celldex Reports Second Quarter 2021 Financial Results and Provides Corporate Update August 5 , 2021 - Positive data from CDX - 0159 Phase 1b Study in Chronic Inducible Urticaria presented at EAACI 2021 - - Raised $ 287 million in gross proceeds from a follow - on public offering of common stock , closed in July 2021 - HAMPTON , N.J. , Aug. 05 , 2021 ( GLOBE NEWSWIRE ) -- Celldex Therapeutics , Inc. ( NASDAQ : CLDX ) today reported financial results for the second quarter ended June 30 , 2021 and provided a corporate update . " Last month , Celldex reported positive data from our ongoing Phase 1b study of CDX - 0159 in chronic inducible urticaria , where a single dose demonstrated a rapid , profound and durable response , " said Anthony Marucci , Co - founder , President and Chief Executive Officer of Celldex Therapeutics . " These data not only spoke to the potential to bring patients suffering from urticaria an opportunity for fast , lasting and meaningful relief , but also showed that CDX - 0159 safely depletes mast cells , a significant scientific and medical achievement that indicates CDX - 0159's potential to help other patients in need across a myriad of diseases with mast cell involvement . " Mr. Marucci continued , “ Importantly , driven by these data , we successfully completed a $ 287.5 million follow - on offering which will support the expansion of the CDX - 0159 program into later stage studies and additional indications , along with the continued development of our bispecific platform , which is exploring important pathways in inflammatory diseases , auto - immune disorders and oncology . We look forward to building on our successes in what promises to be an exciting second half of the year . " Recent Program 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 . • On July 9 , Celldex reported interim data from the CDX - 0159 single dose Phase 1b open label study , which were presented in a late - breaking poster discussion session as part of the European Academy of Allergy and Clinical Immunology ( EAACI ) Annual Congress 2021 . • All 19 patients experienced a clinical response as assessed by provocation threshold testing ; 18/19 ( 95 % ) experienced a complete response and 1/19 ( 5 % ) experienced a partial response . • Rapid onset of responses after dosing and sustained durability were observed and most patients with cold urticaria and symptomatic dermographism experienced a complete response by week 1 and by week 4 , respectively . The median duration of response for patients was 77+ days ( 11+ weeks ) for cold urticaria and 57+ days ( 8+ weeks ) for symptomatic dermographism . • A single 3 mg / kg dose of CDX - 0159 resulted in rapid , marked and durable suppression of serum tryptase and depletion of skin mast cells ( 87 % depletion ) as measured through biopsy . The kinetics of serum tryptase and skin mast cell depletion mirrored clinical activity which confirmed that serum tryptase level is a robust pharmacodynamic biomarker for assessing mast cell burden and clinical activity in inducible urticaria and potentially in other diseases with mast cell driven involvement . • CDX - 0159 was generally well tolerated . The most common adverse events were hair color changes , mild infusion reactions , and transient changes in taste perception . • Celldex plans to present additional Phase 1b single dose data from the cold urticaria and symptomatic dermographism cohorts , including quality of life assessments , in the fall of 2021 and data from the cholinergic cohort in the first quarter of 2022 . • Celldex continues to enroll patients in the Phase 1b multi - center randomized , double - blind , placebo - controlled study of CDX - 0159 in chronic spontaneous urticaria ( CSU ) . This study is 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 . Treatment results from this study are planned for presentation at a scientific congress in early summer of 2022 .