Pfizer Inc. and DxS (a wholly owned subsidiary of Qiagen N.V.) announced that they have entered into an agreement to develop a companion diagnostic test kit for PF-04948568 (CDX-110), an immunotherapy vaccine in development for the treatment of glioblastoma multiforme (GBM). Financial terms of the diagnostic agreement have not been disclosed.

On April 16, 2008, Pfizer and Celldex Therapeutics, Inc. entered into an agreement to grant Pfizer an exclusive worldwide license to PF-04948568 (CDX-110) which is currently in phase 2 clinical development for the treatment of newly diagnosed GBM.

Glioblastoma multiforme is the most common malignant primary brain tumour in adults and occurs in around 25,000 patients worldwide each year. Pfizer’s investigational drug PF-04948568 (CDX-110) is a peptide vaccine which 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 personalized treatment.

The EGFRvIII companion diagnostic will be developed and manufactured at Qiagen’s Center of Excellence for Companion Diagnostics in Manchester, UK. 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.

Commenting on this announcement, Dr Stephen Little, vice president personalized healthcare, for Qiagen, said, “We are very pleased to have signed this agreement with Pfizer, as it is another important step toward the realization of personalized medicine. Qiagen is aligned to deliver companion diagnostics to our pharmaceutical partners and this deal is further evidence of our commitment to develop our scientific and operational capabilities to help select the right patient for the right medicine.”

“We look forward to collaborating with Qiagen's DxS unit in the development of this important diagnostic tool that could potentially help physicians better define the most appropriate treatment for patients who suffer from glioblastoma multiforme,” said Garry Nicholson, president and general manager of Pfizer’s Oncology Business Unit.

Qiagen N.V., a Netherlands holding company and the leading global provider of sample and assay technologies. The company’s products are sold to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers and include one of the broadest panels of molecular diagnostic tests for prevention, profiling and personalized healthcare available worldwide.