Page 1

Celldex therapeutics Celldex Reports Third Quarter 2021 Financial Results and Provides Corporate Update November 9 , 2021 HAMPTON , N.J. , Nov. 09 , 2021 ( GLOBE NEWSWIRE ) -- Celldex Therapeutics , Inc. ( NASDAQ : CLDX ) today reported financial results for the third quarter ended September 30 , 2021 and provided a corporate update . " During the third quarter we reported compelling data from our ongoing Phase 1b study of CDX - 0159 in chronic inducible urticaria , including a rapid , profound and durable 95 % complete response rate to provocation testing after just a single dose , " said Anthony Marucci , Co - founder , President and Chief Executive Officer of Celldex Therapeutics . " Last month , we added to these positive results , reporting additional patient - reported outcome measures that demonstrated rapid and sustained improvement in urticaria disease control and improvements in quality of life . We were also pleased to recently initiate a Phase 1 study of the subcutaneous formulation of CDX - 0159 and recently opened enrollment in the Phase 1b study in prurigo nodularis . " Mr. Marucci continued , " We continue to make significant progress across our clinical pipeline including our bispecific platform , which is exploring important pathways in inflammatory diseases , auto - immune disorders and oncology . We look forward to updating you on these programs over the coming months . " 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 . • In July , Celldex reported interim data from the CDX - 0159 single dose Phase 1b open label study in inducible urticaria , 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 . • In September , Celldex reported symptom control & quality of life measurements data from the CDX - 0159 single dose Phase 1b open label study in inducible urticaria , which were presented in an e - poster session as part of the European Academy of Dermatology and Venereology ( EADV ) 2021 Virtual 30th Congress . • A single 3 mg / kg dose of CDX - 0159 resulted in a rapid and sustained improvement in urticaria control and greatly reduced disease impact on quality of life , as measured by the Urticaria Control Test ( UCT ) and Dermatology Life Quality Index ( DLQI ) . These data support and build on the previously reported 95 % complete response rate to provocation testing . • Additional Phase 1b single dose data from the cholinergic cohort of this study are planned to be submitted for presentation at EAACI 2022 .