PCR-based test will identify tumors expressing cancer-specific EGFRvIII.

The Qiagen subsidiary DxS is to work with Pfizer on the development of a companion diagnostic test kit for the latter’s mid-stage immunotherapy vaccine against glioblastoma (GBM). The aim is to develop a test that can be used routinely to support clinical decision-making.

The peptide vaccine, designated PF-04948568 (previously known as CDX-110), is currently in Phase II trials in patients with newly diagnosed GBM. PF-04948568 targets the mutated, tumor-specific variant III form of the epidermal growth factor receptor (EGFRvIII), which is present in about 25–40% of tumor vaccines, the companies note. DxS will develop a real-time PCR-based EGFRvIII assay designed to test for the variant in tumor tissue.

Pfizer acquired worldwide rights to PF-04948568 from CellDex Therapeutics in April 2008; CellDex was previously called Avant Therapeutics. The deal also gives Pfizer exclusive rights to the use of EGFRvIII vaccines in other indications and included a $40 million up-front payment and a $10 million equity investment.

The company could receive additional milestone fees exceeding $390 million for the successful development and commercialization of PF-04948568 and additional EGFRvIII vaccine products as well as double-digit royalties on any product sales.

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