Cancer

Celldex’s primary focus is in oncology. There are four programs currently in clinical development for treatment of multiple cancers. Our lead program, CDX-110, was recently partnered with Pfizer Inc.; CDX-011 is our lead antibody-drug conjugate with potential for development with our Precision Targeted Immunotherapy Platform; and our additional clinical programs, CDX-1307 and CDX-1401, use our APC Targeting Technology™. A number of additional programs using the APC targeting and therapeutic antibody approaches are progressing towards clinical development.

• CDX-110 - Vaccine for EGFRvIII-expressing tumors: Our lead clinical development program, CDX-110, is an immunotherapy that targets the tumor specific molecule called EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR). EGFRvIII is a common mutated form of the natural EGFR and is present in multiple cancer types. Unlike EGFR, EGFRvIII has not been detected at a significant level in normal tissues, and it can directly lead to cancer through its well documented oncogenic properties that provide a constant growth signal to tumor cells which bear it. Consequently, cells producing EGFRvIII have an enhanced capacity for unregulated growth. CDX-110 is designed to activate the patient’s immune response against tumor cells specifically expressing the EGFRvIII mutation. For information about Clinical Trials with CDX-110 click here.
• CDX-011 - Treatment of Metastatic Breast Cancer and Advanced Melanoma: CDX-011, formerly CR011-vcMMAE, is a fully-human monoclonal antibody-drug conjugate (ADC) that targets glycoprotein NMB, also known as osteoactivin, a protein overexpressed on the surface of cancer cells, including melanoma, breast cancer and gliomas. GPNMB is associated with the ability of the cancer cell to invade and metastasize into tissue and correlates with mortality in breast cancer. The antibody, CDX-011 is linked to a potent chemotherapeutic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into GPNMB-expressing tumor cells, resulting in a targeted cell-killing effect. For information about Clinical Trials with CDX-011 click here. For citations related to CDX-011 click here.
• CDX-1307 - Cancer Program Using APC Technology: Our lead APC Targeting Technology™ product candidate, CDX-1307, is in development for the treatment of colorectal, pancreatic, bladder, ovarian and breast cancers that express the beta chain of human chorionic gonadotropin, known as hCG-β, an antigen often found in these tumors, but not in most normal tissues. hCG-β is an established tumor-associated antigen that is over-expressed in a variety of common cancers including those of the colon, lung, pancreas, esophagus, breast, bladder, cervix, stomach, and prostate. Elevated hCG-β serum levels and/or tissue expansion have also been shown to be an independent predictor of poor disease outcome and are associated with a more aggressive disease course in renal, colorectal, bladder and pancreatic cancers. Mechanistically, it has been proposed that hCG-β may function at several different levels to facilitate cancer progression: as a transforming growth factor, an immunosuppressive agent, an inducer of metastasis, and/or as an angiogenic factor. CDX-1307 is a fusion protein composed of a mannose receptor (MR)-specific immunoglobulin human monoclonal antibody and the hCG-β antigen. This antibody-vaccine is designed to deliver the antigen hCG-β to dendritic cells (DCs) and induce hCG-β specific cellular and humoral immune responses to activate the patient’s immune system against cancers that express hCG-β. For information on Clinical Trials with CDX-1307 click here.
• CDX-1401 - Treatment of Multiple Tumors: CDX-1401 is a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor, DEC-205, linked to the NY-ESO-1 tumor antigen. This product is intended to selectively deliver the NY-ESO-1 antigen to Antigen-Presenting Cells (APCs) for generating robust immune responses against cancer cells expressing NY-ESO-1. NY-ESO-1 represents an important target for developing therapeutics against multiple cancers. The antigen, which is expressed in a wide variety of cancer cells but not at significant levels in most normal tissues, has been extensively characterized in pre-clinical and clinical studies and has been found to be highly immunogenic. For information about Clinical Trials with CDX-1401, click here. For citations related to CDX-1401 click here.
• CDX-014 - Treatment of Multiple Tumors: CDX-014, formerly CR014-vcMMAE, is a fully-human monoclonal ADC that targets TIM-1, an immunomudulatory protein that appears to down regulate immune response to tumors. The antibody, CDX-014 is linked to a potent chemotherapeutic, monomethyl auristatin E (MMAE), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into TIM-1-expressing tumor cells, resulting in a targeted cell-killing effect. CDX-014 has shown potent activity in preclinical models of ovarian and renal cancer. For citations related to CDX-014 click here.
• CDX-1127 - Cancer Immunotherapy: Celldex has entered into a License Agreement with the University of Southampton, UK to develop human antibodies to CD27, a potentially important target for immunotherapy of various cancers. In pre-clinical models, antibodies to CD27 alone have been shown to mediate anti-tumor effects, and may be particularly effective in combination with other immunotherapies. CD27 is a critical molecule in the activation pathway of lymphocytes. It is downstream from CD40 and may provide a novel way to regulate the immune responses. Engaging CD27 with the appropriate monoclonal antibody has proven highly effective at promoting anti-cancer immunity in mouse models. For citations related to CDX-1127 click here.