The right medicine for the right patient

Pfizer, QIAGEN unit to develop companion diagnostic for brain tumor patients

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NEW YORK—Pfizer Inc. has struck a deal with DxS, a wholly owned subsidiary of QIAGEN, for a companion diagnostic test kit that will be used alongside a new brain tumor drug.

That drug, Pfizer's PF-04948568 (CDX-110), is an immunotherapy vaccine for treating newly diagnosed glioblastoma multiforme (GBM), the most common malignant primary brain tumor in adults—occurring in around 25,000 patients worldwide each year. 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 to 40 percent of GBM tumors.

Pfizer and Celldex Therapeutics Inc. signed an agreement in 2008 granting Pfizer an exclusive worldwide license to CDX-110, which is currently in Phase II clinical development. Pfizer is also exploring lifecycle opportunities for CDX-110 in other tumor types expressing the EGFRvIII mutation.

The diagnostic being developed in the Pfizer-DxS deal will be a real-time PCR assay used to detect EGFRvIII RNA in tumor tissue. The EGFRvIII companion diagnostic will be developed and manufactured at QIAGEN's Center of Excellence for Companion Diagnostics in Manchester, U.K. The assay is designed to offer a simple workflow, which supports its clinical utility in routine mutation testing.

In a statement, Pfizer said that by developing CDX-110, its oncology business unit "continues to show its commitment to developing the right drug for each patient."

"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," notes Garry Nicholson, president and general manager of Pfizer's oncology business unit.

Pfizer is the latest global pharmaceutical giant to sign an agreement of this nature with DxS, following similar deals with companies including AstraZeneca and Amgen.
Founded in 2001, DsX is making a name for itself in the field of personalized medicine and has a healthy pipeline of deals, says co-founder Dr. Steve Little, who is also vice president of personalized healthcare for QIAGEN. DxS is also looking to develop kits for use on heart patients as well as those suffering from cancer, he adds.

"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," Little says.

Financial terms of the diagnostic agreement were not disclosed.

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