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CLDX initiates Phase I trial with CDX1127, a fully-human monoclonal antibody


November 8, 2011 - 8:00 AM EST
CLDX 2.89 0.00

Celldex Therapeutics Announces Initiation of Phase 1 Clinical Trial of CDX-1127

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.”

About CDX-1127

CDX-1127 is a human monoclonal antibody program targeting CD27, a member of the tumor necrosis factor (TNF) receptor superfamily. CD27 is a critical molecule in the activation pathway of lymphocytes.

It acts downstream from CD40 and may provide a novel way to regulate the immune responses. CD27 is a co-stimulatory molecule on T cells and is over-expressed in certain lymphomas and leukemias. Previously published data by Professor Martin Glennie, Ph.D., Director of Cancer Sciences, Tenovus Research Laboratory, University of Southampton, UK, has demonstrated that targeting CD27 with monoclonal antibodies in mice is highly effective at promoting anti-cancer immunity. Celldex presented more recent preclinical in vitro and animal data with CDX-1127 at the 2011 American Association for Cancer Research (AACR) 101st Annual Meeting demonstrating that targeting CD27 receptors with CDX-1127 can increase the numbers of responding T cells and can mediate significant anti-tumor activity. CDX-1127 was also shown to directly impact tumor cells expressing CD27. The solid tumor indications that can enroll into the Phase 1 study include; refractory patients with metastatic melanoma, renal (clear) cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian and colorectal adenocarcinoma, and non-small cell lung cancer.

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