NEEDHAM, Mass.--(BUSINESS WIRE)--Celldex Therapeutics, Inc. (NASDAQ: CLDX) today announced that the first patient has been screened in a randomized Phase 2 study of the Company’s novel, first-in-class antibody-based vaccine candidate from its Precision Targeted Immunotherapy (PTI) platform. This study will evaluate the CDX-1307 regimen in both neoadjuvant and adjuvant settings in patients with newly diagnosed muscle-invasive bladder cancers that express hCG-beta. hCG-beta is a tumor-associated antigen (TAA) expressed by several different types of cancers, including bladder cancer. hCG-beta appears to directly facilitate cancer progression and has been shown to correlate with poor prognosis. CDX-1307 is a fully human monoclonal antibody designed to selectively deliver the hCG-beta antigen to dendritic cells. The CDX-1307 vaccine regimen, which includes a novel combination of immune stimulating adjuvants, was developed during Phase 1 trials and has been shown to generate a robust immune response against cancer cells expressing hCG-beta.
