Posted on: 12/07/2007
Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel EGFRvIII...
Celldex Therapeutics Announces Orphan Drug Designation for CDX-110, a Novel
EGFRvIII Vaccine for Glioblastoma Multiforme
Celldex also receives approval from Health Canada to open clinical sites and
establishes a collaboration with the National Cancer Institute
PHILLIPSBURG, N.J., Dec. 7 /PRNewswire/ -- 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."
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
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