Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Gl...( PHILLIPSBURG N.J. Jan. 7 /- Celld...),Health

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: