Deal aggressively targets oncology Dx

GSK and Abbott expand collaboration to develop additional companion diagnostic test for several types of cancer

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ABBOTT PARK, Ill.—At the end of November, longtime pharmapartners GlaxoSmithKline Biologicals SA (GSK) and Abbott Laboratories announcedthey will expand a three-year collaboration in the area of cancer diagnosticsto develop additional tests in support of GSK's cancer immunotherapy researchprogram. 
Since July 2009, the companies have been working to develop apolymerase chain reaction (PCR) test to screen non-small-cell lung cancer(NSCLC) tumors for expression on the MAGE-A3 antigen, a tumor-specific antigenthat is expressed in a large variety of cancers. Under their expandedagreement, Abbott will develop a PCR test for use on the company's m2000rtinstrument to screen NSCLC tumors for the expression of the PRAME antigen, apreferentially expressed antigen of melanoma that is expressed in 69 percent ofNSCLC cases. The new agreement brings other varieties of cancer into thefold—including melanoma, breast, ovarian and bladder cancer—that have limitedexpression in normal cells.
Ultimately, the companies hope Abbott's diagnostics will beused in antigen screening as a first-phase diagnostic for patients. Thediagnostics will support GSK's Antigen Specific Cancer Immunotherapy (ASCI)program, which is comprised of a class of novel compounds based on tumorantigens presented to the patient's immune system as recombinant proteins incombination with a GSK proprietary adjuvant system. ASCIs are meant to triggera specific immune response against tumor cells expressing these proteins,rallying antibodies and T-cells to recognize and attack the cancer cells in ahighly specific manner—and eventually eliminate them.
According to GSK, this approach aims to reduce the risk oftumor recurrence following surgery. It could also be used to impact tumorgrowth in early metastatic settings. The ASCIs' highly targeted mode of actionmay also avoid harming normal tissue, says GSK, and it may also allow selectionof patients eligible for treatment depending on the expression of the tumorantigens. In the end, this may help oncologists to select patient populationsmost likely to respond to treatment, says GSK.
"So once MAGE-A3 is approved and on the market, each patientwould have their biopsied tumor sample tested as a first step using theAbbott-based platform as a first-phase diagnostic for patients, and then as asecond step using Life Technologies for gene signatures as a second stage ofthe patient profiling," explains Sarah Clarkson, a spokeswoman for GSKVaccines.
Indeed, GSK has been very attracted to Abbott's expertise indeveloping diagnostic tests, Clarkson adds.
"One of the reasons GSK partnered with Abbott is that we notonly have experience with development and filing for regulatory approvals, butwe have had a global commercial reach. We have also had successful partnershipswith Pfizer, Roche/Genentech and AstraZeneca," says Kathryn Becker, director ofAbbott Molecular's oncology business.
Considered a pioneer in the use of molecular tests based onPCR and fluorescence in-situhybridization (FISH) technologies to aid clinicians in the selection of appropriatepharmacogenomic therapies, Abbott's overall strategy and focus is "to createnovel molecular diagnostics to improve patient care, including diagnosis,prognosis and prediction of therapeutic response," says Becker. 
"In particular, in the past two years, we have beenconcentrating on the field of companion diagnostics," she says. "There haven'tbeen many successful biomarkers in oncology. Their efficacy is about 25percent. With good science and biomarkers, we will continue to partner withpharmaceutical companies to help identify and deliver novel tests and therapiesto patients around the world."
Financial details of the companies' agreements were notdisclosed.

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