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news.Celldex Therapeutics has received orphan drug designation for rindopepimut, from the European Medicines Agency (EMA), used to treat Glioblastoma (GB).
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Rindopepimut is an immunotherapy that targets the tumor-specific oncogene, EGFRvIII.
Celldex finalized the clinical protocol for the Phase 3 randomized, double-blind study of rindopepimut in GB, after consulting with both US and EU authorities.
The study, named ACT IV will enroll around 374 patients with newly-diagnosed, fully resected, EGFRvIII expressing GB.
The primary endpoint will be overall survival.