Celldex Announces Launch of CDX-0159 Subcutaneous Formulation Study

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Category: Antibodies

Posted on Wednesday, September 15, 2021 3:09 PM

Strokes: 282

HAMPTON, NJ, United States I September 13, 2021 I Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first cohort has been assayed 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 to the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. The Company intends to use the subcutaneous formulation of CDX-0159 in its Phase 2 program in chronic urticaria, scheduled to start in the first half of 2022. Celldex is currently investigating an intravenous formulation of CDX-0159 in Phase 1 studies in chronic spontaneous disease and chronic inducible urticaria and will launch a third intravenous study in prurigo nodularis later this year.

“We believe that CDX-0159 has significant potential to help patients in need in many diseases involving mast cells,” said Diane C. Young, senior vice president and medical director of Celldex Therapeutics. “Advancing the development of the subcutaneous formulation is an important milestone for the CDX-0159 program which will support the initiation of later stage studies next year. “

The randomized, double-blind, placebo-controlled phase 1 study will evaluate single escalating doses of CDX-0159 administered subcutaneously in healthy volunteers. Thirty-two subjects will be recruited into 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 administration. The primary endpoints of the study are safety and tolerability; secondary endpoints include pharmacokinetics, pharmacodynamics (circulating tryptase and stem cell factor), and immunogenicity. For more information on this trial (NCT05031624), please visit www.clinicaltrials.gov.

About CDX-0159
CDX-0159 is a humanized monoclonal antibody that specifically binds to 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 are involved in inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In some inflammatory diseases, such as chronic urticaria, activation of mast cells 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 the development of monoclonal and bispecific antibodies that treat devastating diseases for which available treatments are inadequate. Our pipeline includes antibody-based therapies that 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.

THE SOURCE: Celldex Therapeutics