Pfizer and DxS are to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM).
On April 16, 2008, Pfizer and Celldex Therapeutics entered into an agreement to grant Pfizer an exclusive worldwide licence to PF-04948568 (CDX-110), which is currently in Phase 2 clinical development for the treatment of newly diagnosed GBM.
Pfizer's investigational drug PF-04948568 (CDX-110) is a peptide vaccine that targets the tumour-specific Epidermal Growth Factor Receptor variant III (EGFRvIII), a mutated form of the epidermal growth factor receptor that is only present in cancer cells and occurs in 25-40 per cent of GBM tumours.
The Qiagen assay is designed to identify those patients whose tumours express the EGFRvIII mutation, allowing for the possibility of more targeted and personalised treatment.
The EGFRvIII companion diagnostic will be developed and manufactured at Qiagen's Center of Excellence for Companion Diagnostics in Manchester.
The diagnostic will be a real-time PCR assay used to detect EGFRvIII RNA in tumour tissue.
The assay is designed to offer a simple workflow, which supports its clinical utility in routine mutation testing.