Rindopepimut is an investigational vaccine which has been designed to target a functional variant of the epidermal growth factor receptor (EGFR) – EGFRvIII.
Under the agreement, MDxHealth will use its epigenetic test during Celldex’s enrollment of newly diagnosed glioblastoma multiforme (GBM) patients.
The double-blind, randomized study is designed to enroll up to 440 patients and to select 374 patients with newly-diagnosed, EGFRvIII-expressing GBM.
Patients with EGFRvIII will be tested using epigenetic MGMT prognostic assay to assess methylation status of the MGMT promoter gene.
GBM patients whose tumors are positive for MGMT gene promoter methylation, after following treatment with rindopepimut , have showed to improve their overall survival and progression free survival.