Celldex Announces Initiation of CDX-0159 Subcutaneous Formulation Study

HAMPTON, NJ, USA I September 13, 2021 I Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first cohort has been dosed in the Phase 1 study of the subcutaneous formulation of CDX-0159 in healthy volunteers. CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. The Company intends to utilize the subcutaneous formulation of CDX-0159 in its Phase 2 program in chronic urticarias, planned for initiation in the first half of 2022. Celldex is currently studying an intravenous formulation of CDX-0159 in Phase 1 studies in chronic spontaneous and chronic inducible urticarias and will initiate a third intravenous study in prurigo nodularis later this year.

“We believe CDX-0159 has significant potential to help patients in need across numerous diseases with mast cell involvement,” said Diane C. Young, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Advancing the development of the subcutaneous formulation is an important milestone for the CDX-0159 program that will support the initiation of later stage studies next year.”

The randomized, double-blind, placebo-controlled Phase 1 study will evaluate single ascending doses of CDX-0159 administered subcutaneously in healthy volunteers. Thirty two subjects will be enrolled across four dosing cohorts (50 mg, 150 mg, 300 mg and 600 mg) with 8 subjects in each cohort (6 active; 2 placebo). Subjects will be followed for 12-weeks after dosing. The primary endpoints of the study are safety and tolerability; secondary endpoints include pharmacokinetics, pharmacodynamics (circulating tryptase and stem cell factor) and immunogenicity. For additional information on this trial (NCT05031624), please visit www.clinicaltrials.gov.

About CDX-0159
CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT 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 certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease.

About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company dedicated to developing monoclonal and bispecific antibodies that address devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with inflammatory diseases and many forms of cancer. Visit www.celldex.com.

SOURCE: Celldex Therapeutics

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