Profile: Celldex Therapeutics Inc (CLDX.O)
12 Feb 2016
Celldex Therapeutics, Inc. (Celldex), incorporated on December 9, 1983, is a biopharmaceutical company focused on the development and commercialization of several immunotherapy technologies for the treatment of cancer and other difficult-to-treat diseases. The Company's drug candidates include CDX-110, CDX-011 and CDX-1127. CDX-110, is an immunotherapeutic vaccine that targets the tumor-specific molecule, epidermal growth factor receptor variant III (EGFRvIII). CDX-1127 is a human monoclonal antibody that targets CD27. CD27 is a co-stimulatory molecule on T cells and is over-expressed in certain lymphomas and leukemias. It has additional clinical and preclinical programs, including CDX-1401, an APC Targeting Technology programs, CDX-301, an immune cell mobilizing agent and dendritic cell growth factor and CDX-1135, a molecule that inhibits a part of the immune system called the complement system.
Based on results from three prior Phase 2 trials, during the year ended December 31, 2011, the Company initiated ACT IV, a pivotal, randomized, double-blind, controlled Phase 3 study of rindopepimut in patients with surgically resected EGFRvIII-positive GB. In 2011, the Company also initiated ReACT, a Phase 2 study of rindopepimut in combination with Avastin in patients with recurrent EGFRvIII-positive GB. In December 2011, the Company completed enrollment of EMERGE, a randomized Phase 2b study of CDX-011 in patients with heavily pre-treated, advanced, GPNMB-positive breast cancer
The Company's clinical development program, rindopepimut, is a peptide-based immunotherapy that targets the tumor specific molecule called EGFRvIII, a functional variant of the naturally expressed EGFR, a protein which has been well validated as a target for cancer therapy. The rindopepimut vaccine is composed of the EGFRvIII peptide linked to a carrier protein called Keyhole Limpet Hemocyanin (KLH) and administered together with the adjuvant GM-CSF. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted orphan drug designation for rindopepimut for the treatment of EGFRvIII expressing GB and the FDA has also granted Fast Track designation.
Glembatumumab Vedotin (CDX-011)
The Company’s CDX-011 is an antibody-drug conjugate (ADC) that consists of a human monoclonal antibody, CR011, linked to a potent cell-killing drug, monomethyl-auristatin E (MMAE). The CR011 antibody specifically targets glycoprotein NMB (GPNMB) that is expressed in a variety of human cancers, including breast cancer and melanoma. The ADC is designed to be stable in the bloodstream. CDX-011 is designed to release MMAE from CR011 to produce a cell-killing effect. The FDA has granted Fast Track designation to CDX-011 for the treatment of advanced, refractory/resistant GPNMB-expressing breast cancer.
CDX-1127 is a human monoclonal antibody that targets CD27. CD27 is a co-stimulatory molecule on T cells and is over-expressed in certain lymphomas and leukemias. CDX-1127 is an agonist antibody designed to have two potential therapeutic mechanisms. The Company has entered into license agreements with the University of Southampton, United Kingdom for intellectual property related to uses of anti-CD27 antibodies and with Medarex for accesses to the UltiMab technology to develop and commercialize human antibodies to CD27. CD27 acts downstream from CD40 and may provide a novel way to regulate the immune responses. In November 2011, the Company initiated an open label, dose-escalating Phase 1 study of CDX-1127 in patients with selected malignant solid tumors or hematologic cancers.
The Company’s CDX-1401is a fusion protein consisting of a human monoclonal antibody with specificity for the dendritic cell receptor, DEC-205, linked to the NY-ESO-1 tumor antigen. The Company develops CDX-1401 for the treatment of malignant melanoma and a variety of solid tumors, which express the cancer antigen NY-ESO-1, which the Company licensed from the Ludwig Institute for Cancer Research. Preclinical studies have shown that CDX-1401 is effective for activation of human T cell responses against NY-ESO-1. In February 2012, the Company completed enrollment in the Phase 1 portion of the study and expect to report data at an appropriate scientific conference in the second half of 2012.
The Company’s CDX-301 is a FMS-like tyrosine kinase 3 ligand (Flt3L) stem cell mobilizer and dendritic cell growth factor. CDX-301 is a potent hematopoietic cytokine that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. CDX-301 has demonstrated a capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In January 2012, the Company initiated a dose-escalating Phase 1 study of CDX-301 in approximately 30 healthy subjects in collaboration with Rockefeller University.
The Company’s CDX-1135 is a molecule that inhibits a part of the human immune system called the complement system. CDX-1135 is a soluble form of naturally occurring complement receptor 1 that showed to inhibit the activation of the complement cascade in animal models and in human clinical trials. In preclinical studies, CDX-1135 has been shown to inhibit both the classical and alternative pathways of complement activation. In 2011, the Company completed process development activities and manufactured GMP clinical drug product.
The Company’s CDX-014 is a human monoclonal ADC that targets TIM-1, a molecule that is expressed on renal and ovarian cancers with minimal expression in normal tissues. The antibody, CDX-014, is linked to a potent chemotherapeutic, monomethyl auristatin E (MMAE), using Seattle Genetics' technology. CDX-014 has shown potent activity in preclinical models of ovarian and renal cancer.
The Company competes with Alexion, Agenus, Baxter, BMS, Dendreon, Eli Lilly, GlaxoSmithKline, ImmunoGen, Merck, Pfizer, Roche, Sanofi-Aventis, Seattle Genetics, and Takeda
Celldex Therapeutics Inc
519 Route 173 West
BLOOMSBURY NJ 05504