"for opportunities in multiple settings and in combination with other therapies which are planned to initiate in the near future."
Celldex, aka synergistic combination therapeutics is going to make us rich!
CDX-1401 is a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The NY-ESO-1 antigen is expressed in a variety of cancer cells. Targeting protein antigens to the DEC-205 receptor on dendritic cells was pioneered by the late Ralph Steinman, MD, a member of Celldex's Scientific Advisory Board. Dr. Steinman received the 2011 Nobel Prize in Physiology or Medicine for his discovery of the dendritic cell and its role in adaptive immunity. In preclinical studies, CDX-1401 has been shown to induce potent and broad immunity. At the 2012 Society for Immunotherapy Annual Meeting, results from a Phase 1 study of CDX-1401 were presented. This clinical study was the first to demonstrate that an off-the-shelf vaccine targeting dendritic cells in vivo through DEC-205 can safely lead to robust humoral and cellular immunity when combined with TLR agonists in cancer patients, overcoming a significant challenge in the development of protein based vaccines. This initial study has set the stage for opportunities in multiple settings and in combination with other therapies which are planned to initiate in the near future.