Companion Diagnostic in Development for Glioblastoma Multiforme Patients

A companion diagnostic test kit is being developed for an immunotherapy vaccine for the treatment of glioblastoma multiforme (GBM).

The vaccine is called PF-04948568 (CDX-110), and is currently in Phase 2 clinical development for the treatment of newly diagnosed GBM.

Pfizer Inc. (New York, NY, USA) and DxS (Manchester, UK), a wholly owned subsidiary of Qiagen (QIA; Frankfurt, Germany), have entered into an agreement to develop the companion diagnostic test kit. In 2008, Pfizer received an exclusive worldwide licence to PF-04948568 (CDX-110) from Celldex Therapeutics Inc. (Needham, MA, USA).

The investigational drug PF-04948568 (CDX-110) is a peptide vaccine which targets the tumor-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 % of GBM tumors. The Qiagen assay is designed to identify patients, whose tumors express the EGFRvIII mutation, allowing for the possibility of more targeted and personalized treatment.

The EGFRvIII companion diagnostic will be developed and manufactured at Qiagen's DxS unit. The diagnostic will be a real-time polymerase chain reaction (R-T PCR) assay used to detect EGFRvIII RNA in tumor tissue. The assay will offer a simple workflow, supporting its clinical utility in routine mutation testing.

Pfizer Oncology is committed to the discovery, investigation, and development of treatment options to improve the outlook for cancer patients worldwide.

Qiagen is a global provider of sample and assay technologies. The company's products include one of the broadest panels of molecular diagnostic tests for prevention, profiling, and personalized healthcare available worldwide.

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