Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been dosed in a Phase 1/2 study of its vaccine candidate, CDX-1401, in patients with malignant solid tumors that express NY-ESO-1. CDX-1401 is a fully human monoclonal antibody designed to selectively deliver the NY-ESO-1 antigen to dendritic cells to generate a robust immune response against cancer cells expressing NY-ESO-1. NY-ESO-1 is a tumor-associated antigen (TAA) expressed by several different types of cancers including lung, ovarian, prostate, bladder, melanoma, liver and esophageal cancers as well as multiple myeloma.
The Phase 1/2 study is a dose-escalating clinical trial aimed at determining the optimal dose for further development based on the safety, tolerability, and immunogenicity of the CDX-1401 vaccine. The trial will evaluate three different doses of the vaccine in combination with resiquimod, an activator of toll-like receptors 7 and 8. The study will accrue approximately 36 patients with solid tumor cancers expressing the NY-ESO-1 antigen and will follow each subject for six months post-treatment. The study is being conducted at multiple clinical sites in the United States, including Yale University, Henry Ford Health System and Cornell University.
“CDX-1401 is Celldex’s third clinical product and the second program generated by the Company’s proprietary Precision Targeted Immunotherapy (PTI) Platform,” stated Anthony Marucci, President and CEO of Celldex Therapeutics. “The PTI Platform embodies what we believe to be the future of treatment for life threatening and debilitating diseases through a combination immunotherapy approach.”