CDX-527 is the first candidate from Celldex’s bispecific antibody platform. It uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 costimulation with blockade of the PD-L1/PD-1 pathway to help prime and activate anti-tumor T cell responses through CD27 costimulation, while preventing PD-1 inhibitory signals that subvert the immune response. Preclinical data demonstrate CDX-527 is more potent than the combination of anti-PD-L1 and anti-CD27 antibodies in T cell activation and anti-tumor activity. In addition, CDX-527 exhibits an antibody-like pharmacokinetic profile without concerning toxicity in preclinical models. Prior clinical data with Celldex’s CD27 antibody as monotherapy and in combination with PD-1 inhibitors, supports combining these pathways in patients with cancer. The Company believes that the potential for CDX-527 will include both monotherapy and combination studies with other immunotherapies or conventional cancer treatments.

Ongoing Clinical Trials

Celldex has initiated an open-label, Phase 1 study in patients with solid tumors. This study is designed to determine the maximum tolerated dose during a dose-escalation phase and to recommend a dose level for further study in a subsequent expansion phase. The expansion phase is designed to further evaluate the tolerability and biologic effects of selected dose level(s) of CDX-527 in specific tumor types. Secondary objectives of the study include analyses of safety and tolerability, pharmacokinetics, immunogenicity and assessment of anti-tumor activity across a broad range of endpoints, such as objective response rate, clinical benefit rate, duration of response, progression-free survival and overall survival.

For more information on the CDX-527 program, view recent scientific presentations and publications.