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UPitt Alliance with Clinical Data Could Yield IP Related to PGx Response to mAb Cancer Therapies

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The University of Pittsburgh has inked a broad research collaboration with PGx Health, a division of Clinical Data, to discover and validate how specific genetic variants can predict the response of monoclonal antibody-based cancer treatments, the company said this week.

From Clinical Data's perspective, the overarching goal of the partnership is to further validate intellectual property already owned by the company related to how genetic variants of a family of Fc gamma receptor genes can predict response to mAb-based cancer therapies, particularly the IgG1 class of therapies, a Clinical Data spokesperson told BTW.

However, the collaboration also has the potential to generate new IP surrounding the role FCGR variants play in predicting therapeutic response to IgG1 treatments in a variety of cancers and other diseases – IP in which the University of Pittsburgh would own a stake.

"The IP we have around the gene and its variants we obviously retain; and any IP that would come out of the collaboration would be jointly owned and therefore negotiable between the parties, depending on what it is," said Theresa McNally, vice president of corporate communications for Clinical Data.

"We would then be looking to commercialize potential tests associated with drug response, as is our business in this area," she added. Were such a test to be developed based on the collaborative research, the University of Pittsburgh would be in line to receive royalty payments on its sale.

Officials from the university could not be reached for comment on the IP aspects of the agreement before press time.

According to Clinical Data, the collaboration builds upon a "large and growing body of evidence" demonstrating the contribution of genetic variants in the FCGR family to mAb response in cancer treatment, including FCGR3A, the variants of which have been studied as a way to optimize treatments for lymphoma, breast cancer, and colorectal cancer with IgG1 treatments such as rituximab, trastuzumab, and cetuximab, marketed as Rituxan, Herceptin, and Erbitux, respectively.

FCGR3A encodes an Fc gamma receptor found on immune cells that binds both natural and therapeutic IgG1 antibodies. The receptor transmits signals from the membrane into the cell via tyrosine kinase activity. This signaling pathway is important in regulating antibody-dependent cellular cytotoxicity, a mechanism that is important to the efficacy of many mAb therapies, Clinical Data said.

Clinical Data also said that the new alliance expands its own FCGR program, which includes collaborations with other researchers, such as the partnership it announced in November with Antonino Musolino and colleagues at the University Hospital of Parma in Italy in the area of breast cancer patient response to trastuzumab; as well as its PGxPredict:Rituximab test for a gene variant used to predict response to rituximab montherapy in follicular non-Hodgkin's lymphoma.

The initial research program at the University of Pittsburgh will involve the laboratory of Robert Ferris, associate professor and chief of head and neck surgery at the University of Pittsburgh Cancer Institute.

Specifically, Ferris will initially lead studies focusing on the use of Erbitux to treat head and neck cancer, an indication for which it has been approved in the US and which has been shown to increase survival in this population.

"It is a sponsored research agreement and is pretty typical in terms of how it's structured," McNally said, though she declined to disclose specific financial details. "We're looking to validate some IP we already have around [FCGR genes and their variants] and their association with drug response to this particular class of drugs."

However, PGxHealth and UPCI plan to expand the scope of their research in the "near term" to include other cancers and treatments, the company said in a statement. The research may also extend to other disease areas where mAb therapies are important, such as rheumatoid arthritis, Clinical Data said.

"The University of Pittsburgh agreement is important to us because it is going to be a series of collaborations under this master agreement," McNally elaborated. "Our intent is to go across cancer and different treatment settings.

"This is a very important step in the area of head and neck cancer," she added. "But we've already been talking to other principal investigators at UPCI working in different cancer areas to develop protocols for other studies. That's currently underway."

McNally cited colorectal cancer, other lymphomas, and breast cancer as cancer classes that might eventually be explored under the partnership – "basically where some of the other treatments are for mAbs in this area," she said.

It is possible that the study could reveal a previously undiscovered role that genetic variants of the FCGR genes play in predicting response to any of these cancers or other inflammatory diseases. Were that to occur, Clinical Data and the University of Pittsburgh could jointly file patents related to the discovery.

"There is growing evidence that this is a very important gene and pathway for drug response to mAbs," McNally said. "We already have a test on the market that involves these genes and its variants – so we're looking broaden that idea and validate some of these earlier studies."

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