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, M.D., 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.

Ongoing Clinical Trials

CDX-1401’s potential activity is being explored in investigator sponsored and collaborative studies.

Combination with CDX-301 in Malignant Melanoma

A Phase 2 study of CDX-1401 in combination with CDX-301 is being conducted in malignant melanoma by the Cancer Immunotherapy Trials Network (CITN) under a CRADA with the Cancer Therapy Evaluation Program of the NCI. This study was designed to determine the activity of CDX-1401 with or without CDX-301 in melanoma. The primary outcome measure of the study is immune response to NY-ESO-1. Secondary outcome measures include analysis and characterization of peripheral blood mononuclear cells (dendritic cells, T cells, natural killer cells, etc.), additional immune monitoring, safety and clinical outcomes (survival and time to tumor recurrence). At the 2016 ASCO Annual Meeting, initial results were presented that confirmed that CDX-1401 is capable of driving NY-ESO-1 immunity and further demonstrated the potential of CDX-301 as a combination agent for enhancing tumor specific immune responses. The NCI and CITN are planning to enroll additional cohorts to investigate alternate regimens of CDX-301.

Combination with Tecentriq® and SGI-110 in Ovarian Cancer

In September 2017, a randomized, open-label Phase 1/2 study of CDX-1401 in combination with Tecentriq® (atezolizumab) and SGI-110 opened to enrollment in recurrent ovarian, fallopian tube, or primary peritoneal cancer. This study is being conducted under a CRADA with the NCI Division of Cancer Treatment and Diagnosis and is designed to determine the activity of atezolizumab alone, atezolizumab plus SGI-110 and atezolizumab plus SGI-110 plus CDX-1401. The primary outcome of the Phase 1 dose escalation study is safety and only evaluates atezolizumab alone and in combination with SGI-110. The Phase 2 portion of the study is expected to add CDX-1401. The primary outcome of the Phase 2 portion of the study is a comparison of PFS between the three cohorts.

Tecentriq is a registered trademark of Genentech, Inc., a member of the Roche Group.

For more information on the CDX-1401 program, view recent scientific presentations and publications.