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Clinical Data Inks PGx Deal with U of Pittsburgh to Discover, Validate FCGR Markers

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Clinical Data has entered into a collaboration with the University of Pittsburgh to discover and validate Fc gamma receptor gene markers that may eventually lead to the development of new pharmacogenetic tests that gauge response to monoclonal antibodies, such as Herceptin, Rituxan, and Erbitux.

The research partnership, announced this week, will expand Clinical Data's existing FCGR program under its PGx Health division, which includes the PGxPredict: Rituximab test and research collaborations with other institutions.

"Our goal is to validate the biomarkers or genetic variants associated with response and potentially discover other genetic variants in this gene and their impact on response to IgG1 mAb-based therapies," a Clinical Data spokesperson told Pharmacogenomics Reporter this week. The company aims "to utilize this information in developing tests to predict drug response, as we have done with our PGxPredict: Rituximab test."

The announcement is in line with the company's previously outlined 2009 strategic goals, which include driving adoption of its Familion and PGxPredict brand of assays in the cardiovascular disease market, and establishing research collaborations to discover and validate genetic variants in the FCGR pathway that predict response for monoclonal antibodies [see PGx Reporter 12-31-2008].

Under the research collaboration between the University of Pittsburgh and Clinical Data, the partners are planning to conduct a series of clinical trials to gauge the link between FCGR gene variants and response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab), Herceptin (trastuzumab), and potentially other mAb cancer drugs in the IgG1 subclass.

The initial research program between PGxHealth and the university will focus on gauging responsiveness to Erbitux in head and neck cancer patients. Robert Ferris, associate professor and chief of the head and neck surgery division at the University of Pittsburgh Cancer Institute, will lead the study.

Erbitux, marketed by Bristol-Myers Squibb in the US, is approved by the US Food and Drug Administration for the treatment of head and neck cancer and colorectal cancer. In head and neck cancer patients the drug has been shown to increase survival.

At this early stage in the deal, the partners are holding off on disclosing the design and timeline of the studies. However, according to the Clinical Data spokesperson, other studies could look at the link between FCGR and response to other mAbs in the class for the treatment of breast cancer, colorectal cancer, and lymphomas, as well as other types of diseases, such as rheumatoid arthritis.

"UPCI is one of the leading research institutions in the country and this collaboration represents a significant step forward in our goal to expand our Fc gamma program in oncology," Marcia Lewis, VP of biomarker development at PGxHealth, said in a statement.

Fc gamma receptors are proteins found in immune-regulatory white blood cells that bind to antibodies attached to infected cells or invading pathogens. Clinical studies have linked genetic variants in the FCGR pathway to monoclonal antibody response in cancer patients.

Of particular interest is FCGR3A, a gene that encodes an Fc gamma receptor and binds both natural and therapeutic IgG1 antibodies. Clinical Data's PGxPredict: Rituximab is a laboratory-developed test that interrogates for the V158F polymorphism in the FCGR3A gene.

Financial terms of the deal were not announced. However, PGxHealth would retain rights to its own IP surrounding the FCGR3A gene and certain variants associated with response that are being validated through the collaboration.

"For any new discoveries born of the collaborations, the parties would negotiate for rights to the jointly owned IP," the Clinical Data spokesperson said. For instance, a test developed out of new biomarker discoveries would involve a royalty arrangement with the University of Pittsburgh, the spokesperson added.

Clinical Data isn't the only company looking to introduce pharmacogenomic tests to guide cancer treatment with monoclonal antibodies. UK-based DxS markets a test that determines responsiveness to mAb drugs such as Vectibix and Erbitux by detecting wild-type KRAS mutations in colorectal cancer patients [see PGx Reporter 02-04-2009].

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