Pharmaceutical Business review

Celldex receives Orphan Drug Designation for Rindopepimut

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.