Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma
Monday January 7, 7:00 am ET
[Medarex must be one of very few biotechs, that doesn't even seem to bother to acknowledge what is going on in one of its majority-owned daughter-companies].
PHILLIPSBURG, N.J., Jan. 7 /PRNewswire/ -- Celldex Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celldex's CDX-110 for the treatment of EGFRvIII expressing Glioblastoma Multiforme (GBM). GBM is the most common and aggressive form of primary brain cancer and carries a very poor prognosis with current therapy. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII that can be expressed by GBM.
In the ACTIVATE Phase 2a study, GBM patients treated with CDX-110 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. GBM that recurred after treatment with CDX-110 consistently lost EGFRvIII expression with its aggressive growth signal. 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. 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 2/3 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 recently announced that CDX-110 has also been granted Orphan Drug Status by the FDA. Celldex Therapeutics announced a definitive merger agreement with AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN - News) in October 2007.
"Fast Track status acknowledges CDX-110's potential to fill an unmet need for glioblastoma patients and gives it priority within the FDA," said Thomas Davis, M.D., Chief Medical Officer of Celldex Therapeutics. "Confirmation of the promising results we've already observed is a high priority at Celldex, as it is within the brain cancer community in general."
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 studies.
About Fast Track Drug Designation
Under the FDA Modernization Act of 1997, designation as a Fast Track product for a new drug or biological products means that FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product. FDA may also evaluate for filing and commence review of portions of an application for approval of a Fast Track product under certain conditions. |
