Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma ...(nd safety ofthe addition of CDX-110 vacc...),Health

Date:12/7/2007

nd safety of the addition of CDX-110 vaccine to standard of care, versus standard of care alone. Celldex has currently enlisted 18 clinical centers throughout the United States, and also recently received approval from Health Canada to open enrollment in Canada. Furthermore, The National Cancer Institute (NCI) has agreed to collaborate with Celldex in expanded clinical development of CDX-110 under a Clinical Trials Agreement.

"Obtaining orphan designation for CDX-110 is an important milestone for Celldex," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Approval to expand clinical research into Canada and the scientific and clinical collaboration from the National Cancer Institute all promote our ability to fully explore the promise of CDX-110."

About CDX-110

CDX-110 is an investigational immunotherapy that targets the tumor specific molecule EGFRvIII, a functional variant of the epidermal growth factor receptor (EGFR), which is a protein that has been well validated as a target for cancer therapy. This particular variant, EGFRvIII occurs in about 40 percent of Glioblastoma Multiforme (GBM) patients. It was discovered in a collaborative effort between Dr. Bert Vogelstein and Dr Albert Wong at Johns Hopkins University and Dr. Darell Bigner at Duke University. Unlike EGFR, EGFRvIII is not present in normal tissues, suggesting this target will enable the development of a tumor-specific therapy for cancer patients. Furthermore, EGFRvIII is a transforming oncogene that can directly contribute to cancer cell growth. While originally discovered in GBM, the most common and aggressive form of brain cancer, the expression of EGFRvIII has also been observed in various other cancers such as breast, ovarian, metastatic prostate, colorectal, and head & neck cancers. Celldex has exclusive rights to EGFRvIII vaccines and is pursuing the development of CDX-110 for GBM therapy, as well as in other cancers through additional clinical studi
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