Celldex Therapeutics Announces Orphan Drug Designation For CDX-110, A Novel EGFRvII Vaccine For Glioblastoma Multiforme

PR Newswire

December 7, 2007

PHILLIPSBURG, N.J. -- Celldex Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Celldex's CDX-110 for the treatment of EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common and aggressive form of brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII. Celldex Therapeutics announced a definitive merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) in October 2007.

In the ACTIVATE phase IIa study, CDX-110 treated GBM patients showed a median survival time of 30 months, more than a 100 percent increase in survival, versus the historical control's median of 14.5 months. The study has demonstrated a median time-to-progression of 13 months (p=0.0001) versus the historical control's median of 6.4 months. An extension study, ACT II, which combines CDX-110 with chemotherapy in a similar patient population, has not yet reached median time-to-progression or survival. However, preliminary progression free survival (PFS) and overall survival (OS) data in ACT II look very similar to the ACTIVATE experience, and the data suggest that chemotherapy and CDX-110 can be administered concurrently while still maintaining strong immune responses.

In September, Celldex randomized its first patient into ACT III, a definitive Phase II/III randomized study of CDX-110 with radiation and temozolomide in patients with newly-diagnosed GBM. The clinical trial is investigating the anticancer activity, impact on survival, and 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."