Celldex Reports Positive Phase 1 Results For Tumor Vaccine
Celldex Therapeutics reported positive final data from the Phase I study of its tumor vaccine CDX-1401 in solid tumors.
CDX-1401 is an off-the-shelf vaccine comprised of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The vaccine is designed to stimulate the immune system to target cancers expressing the tumor marker NY-ESO-1.
“CDX-1401 offers a novel, well-tolerated and practical approach to generating protein specific immunity that can be readily combined with other treatment strategies to boost immunity against pathogens and tumors. The preliminary findings in patients who received therapy with a checkpoint inhibitor following the vaccine provide further rationale for combination immunotherapy strategies, meriting further investigation,” said Dr. Madhav Dhodapkar, lead author of the paper and Clinical Research Program Leader of the Hematology Program at Yale Cancer Center.
The Phase I trial is the first clinical study to demonstrate that an off-the-shelf vaccine such as CDX-1401 that targets dendritic cells in vivo through DEC-205 can safely lead to robust humoral and cellular immunity. The company said this indicates overcoming a significant challenge in the development of protein based vaccines. Data from the trial show CDX-1401 demonstrated robust antibody activity and T cell responses as well as evidence of clinical benefit in patients with very advanced cancers.
Thomas Davis, SVP and CMO of Celldex Therapeutics, said, “CDX-1401 has overcome a significant historical challenge in the development of protein based vaccines by successfully targeting dendritic cells in vivo. It now sits at the forefront of a new generation of off-the-shelf dendritic cell targeted vaccines that we believe hold significant promise. Based on the results observed in this Phase 1 study, we expect CDX-1401 to enter at least two combination studies this year with both our own investigational therapies and external therapies in melanoma and other indications where we believe a dendritic cell vaccine regimen could play an important role.”
Initial results of the CDX-1401Phase 1 study were presented at the 2012 Society of Immunotherapy Annual Meeting. Final data from the study have been published in Science Translational Medicine.