Celldex commences dosing patients in Phase 1/2 study of its CDX-1401 vaccine candidate

Sep 14 2009

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.”

“NY-ESO-1 is an excellent target for Celldex’s PTI Platform because it is expressed in many cancers and is known to be one of the most immunogenic tumor antigens - creating a promising clinical opportunity,” said Tom Davis, MD, Chief Medical Officer of Celldex Therapeutics. “Our PTI Platform includes proprietary immunomodulators and human monoclonal antibodies to dendritic cell receptors, which are used to deliver antigens directly to dendritic cells in the body. This technology takes advantage of many important characteristics of monoclonal antibodies, including their specific targeting capability, which helps focus the immune system on the cancer.”

Celldex’s PTI Platform combines synergistic technologies to fuel the rational design of new therapeutics and targeted treatment regimens that maximize the beneficial aspects of the immune system. The Company’s focus is on the use of tumor-specific targets and human monoclonal antibodies to precisely deliver therapeutic agents through their novel targeted immunization approach. Celldex’s deep pipeline consists of product candidates in varying stages of development, with lead candidate CDX-110, partnered with Pfizer, currently undergoing evaluation in a Phase 2 clinical trial in newly diagnosed glioblastoma multiforme (GBM), CDX-1307, currently enrolling in a Phase 1 study in epithelial tumors and now CDX-1401, currently enrolling in a Phase 1/2 study in malignant solid tumors that express NY-ESO-1.