PHILLIPSBURG, N.J., June 3 /PRNewswire/ -- Celldex Therapeutics today announced that Dr. Michael Morse of Duke University presented data from a Phase 1, dose-escalating study of CDX-1307, the Company's lead cancer program using its proprietary Antigen Presenting Cell (APC) targeting technology, in a poster presentation at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. The interim results of the study suggest that intradermal administration of CDX-1307 results in localization of Beta subunit of human chorionic gonadotropin (Beta hCG) in antigen-presenting cells of the skin. These interim results also indicate that the addition of GM-CSF to CDX-1307 treatment may serve to enhance immune responses to Beta hCG, and may represent a completely novel way of immunizing patients via antibody delivery.
CDX-1307 is a novel immunotherapy approach designed to stimulate the immune system against the Beta subunit of hCG, a tumor-associated antigen selectively over-expressed by many cancers including colorectal, pancreatic, bladder and breast cancers that has been correlated with stage of disease and prognosis. CDX-1307 couples Beta hCG to a novel human monoclonal antibody targeting dendritic cells, key cells of the immune system. This targeting directs the Beta hCG to an endocytic pathway within the dendritic cells that leads to activation of hCG-Beta specific cytotoxic T cells (CTLs) and T helper cells. Celldex has demonstrated the efficacy of this approach in preclinical models using Beta hCG-expressing tumors and cell lines.
In the Phase 1 study, sequential cohorts of 6 patients with relapsed epithelial tumors receive 4 biweekly intradermal injections of CDX-1307 at 0.3, 1.0 or 2.5 mg, or 2.5 mg concurrent with GM-CSF, a white blood cell growth factor. Enrollment is complete and patients experienced no dose- limiting toxicities. Common potential treatment-related toxicities were injection site reaction and fatigue/malaise. Two patients developed anti-Beta hCG immune responses after treatment with CDX-1307 alone. In cohort 4 (CDX- 1307 with GM-CSF), 2 of 3 patients developed robust anti-Beta hCG immune responses after 2 doses and in one patient, the immune response was coincident with a normalization in serum Beta hCG. Complete immune response data and tumor impact are currently under evaluation.
"We are encouraged to see clinical data that show the ability of our APC technology to deliver the Beta hCG antigen to targeted dendritic cells and generate the desired immune response," said Robert F. Burns, Ph.D., President and CEO of Celldex Therapeutics. "We look forward to the next stages of CDX- 1307 clinical development, where we intend to explore its full potential."
About CDX-1307
CDX-1307 is our lead Antigen Presenting Cell (APC) Targeting Technology product candidate. CDX-1307 is in development for the treatment of colorectal, pancreatic, bladder and breast cancers that express the Beta chain of human chorionic gonadotropin, known as Beta hCG, an antigen often found in tumors of these types of cancer. The presence of Beta hCG in these cancers correlates with a poor clinical outcome, suggesting that this molecule may contribute to tumor growth. Normal adult tissues have minimal expression of Beta hCG, therefore, targeted immune responses are not expected to generate significant side effects.
About Celldex Therapeutics, Inc.
Celldex Therapeutics, Inc. is a biotechnology company focused on developing therapeutic vaccines that target and stimulate the body's immune system for the treatment of cancer, infectious and autoimmune diseases. Celldex has three product candidates already in or about to enter clinical development targeting multiple cancers and Hepatitis B. Four additional product candidates are in preclinical development for cancer and autoimmune disease. Celldex's proprietary technology platform uses fully human monoclonal antibodies administered directly to patients to target and stimulate dendritic cells -- key cells within the immune system. Celldex was formed in 2004 as a spin-out from Medarex, Inc. The Company is headquartered in Phillipsburg, New Jersey. For more information, please visit the website: http://www.celldextherapeutics.com.
Celldex Therapeutics, Inc.CONTACT: Robert Burns, Chief Executive Officer, +1-908-454-7120, or ThomasDavis, Chief Medical Officer, +1-908-454-7120, both of CelldexTherapeutics, Inc.; or Dan Budwick of BMC Communications, +1-212-477-9007x14, for Celldex Therapeutics, Inc.
Web site: http://www.celldextherapeutics.com/
