Celldex Therapeutics, Inc. (Nasdaq: CLDX) today announced initiation of a Phase 1 study of its therapeutic human antibody candidate, CDX-1127, in patients with selected malignant solid tumors or hematologic cancers. CDX-1127 is a fully human monoclonal antibody that binds CD27, an important co-stimulatory molecule on T cells. CDX-1127, an agonist antibody designed to activate patients' immune cells against their cancer, has shown potent efficacy in several preclinical models. In addition, CD27 is over-expressed in certain lymphomas and leukemias and can be directly targeted by CDX-1127.
The Phase 1 study is designed to test 5 escalating doses of CDX-1127 to determine a Phase 2 dose for further development based on safety, tolerability, potential activity and immunogenicity. The study will accrue approximately 30 patients in each of the two arms, either solid tumors or lymphomas/leukemias. Patients will have received all appropriate prior therapies for their specific disease. The trial design incorporates both single dosing and multiple dosing regimens at each dose level. The study, anticipated to complete accrual in approximately 1 year, is being conducted at multiple clinical sites in the United States.
"The CDX-1127 program is our first therapeutic antibody and demonstrates our development capabilities to rapidly and successfully translate concept into clinical trials," said Anthony S. Marucci, President and Chief Executive Officer of Celldex Therapeutics. "We believe strongly in the opportunities for immune modulating antibodies and the pre-clinical data generated with CDX-1127 through our collaboration with University of Southampton, UK has been very encouraging."