Paving the way to personalized medicine
December 2012
by Ilene Schneider  |  Email the author


CAMBRIDGE, Mass.—In what Dr. Michael J. Pellini, president and CEO of cancer diagnostics company Foundation Medicine Inc., describes as "a clear alignment between the companies in technology, expertise and innovation," Foundation Medicine has announced a multiyear collaboration with AstraZeneca PLC to identify alterations found in cancer-related tumor genes that may predict a person's response or resistance to targeted medicines. The collaboration will target all solid tumors.
"Together, we expect to enable a more individualized, targeted approach to cancer drug development and clinical trials," Pellini says. "Foundation Medicine has a clear interest in working to help expand the universe of targeted therapeutic options—more therapeutics make our fully informative genomic profile increasingly actionable, and AstraZeneca has launched some of the most high-impact new targeted therapeutics for cancer."  
Foundation Medicine has opportunities to develop and commercialize potential diagnostic products. Under the terms of the collaboration, Foundation Medicine was also granted right of first negotiation for the development of potential diagnostic products.
"AstraZeneca has a firm commitment to personalized healthcare, and Foundation Medicine has quickly become a partner of choice in this space, so it makes good sense for us to work together," adds Susan Galbraith, vice president and head of the Oncology Innovative Medicines unit at AstraZeneca. "There are several examples of oncology compounds in the pipeline, based on data that has emerged this year, which identify groups of patients that respond better to specific drugs. These include selumetinib in non-small cell lung cancer and olaparib in genetic BRCA ovarian cancer."  
This is the fourth such collaboration this year for Foundation Medicine, which was founded in 2010 by experts in genome technology, cancer biology and medical oncology from the Broad Institute, Dana-Farber Cancer Institute, Harvard Medical School and MIT. The partnering vein that runs through AstraZeneca's R&D organization applies to personalized healthcare as well, as the company has more than 36 collaborations—half biotech and half academic—established in this space, according to Galbraith.
Initially, Foundation Medicine will use its comprehensive genomic assay to look retrospectively at patient samples from an AstraZeneca clinical trial to identify genomic patterns. These results may help AstraZeneca to research new medicines for people with cancer.  
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer, according to Pellini. The company has developed a fully informative genomic profile to identify a patient's individual molecular alterations and match them with relevant targeted therapies and clinical trials. 
"Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer," he says.
AstraZeneca has a dedicated personalized healthcare team within its R&D organization. Developing ways to identify and validate specific markers that can be used by drug project teams to segment patient groups for particular therapies, the team takes these markers through the analytical validation stage, then shares them with external partners to be developed into actual diagnostic tools. 
"Cancer is the most advanced therapeutic area for our personalized healthcare team, and about half their work is with oncology, followed by asthma and inflammation," Galbraith says. "In the coming year, we expect to make decisions about whether two drugs will enter into Phase III development with companion diagnostics, and we are hopeful we will see more in the future."  
As to how the collaboration will pave the way to personalized medicine, Pellini says, "by identifying alterations found in cancer-related tumor genes that may predict a person's response or resistance to targeted medicines, we aim to find the right therapies for the right patients to attack their unique tumor."
Galbraith summarizes, "Even the most in-depth genomic profile for a patient is only as actionable as the available and relevant targeted therapies. We hope that the information gleaned from our collaboration with Foundation Medicine will improve our ability to develop the right medicines for the right patient populations."

Foundation Medicine and ARIAD in genomic profiling pact  
CAMBRIDGE, Mass.—On Nov. 12, Foundation Medicine Inc. and ARIAD Pharmaceuticals Inc. announced a genomic profiling collaboration to study AP26113, ARIAD's investigational dual-inhibitor of ALK and EGFR in patients with non- small cell lung cancer and other cancers. Foundation Medicine will work with ARIAD to generate genomic profile information for patients enrolled in ARIAD's ongoing Phase I/II trial, and this data will be matched with clinical observations to understand the activity and selectivity profile of AP26113.
"It is important that we have a deep molecular understanding of patients' tumors as they begin treatment with AP26113, especially those patients with complex prior treatment histories," stated Dr. Timothy P. Clackson, president of research and development and chief scientific officer at ARIAD. "Foundation Medicine is at the forefront of genomic profiling technologies that will provide molecular insights on a wide array of clinically relevant tumor genes, including ALK and EGFR alteration status. We look forward to collaborating on the AP26113 program as we move into anticipated pivotal trial(s) in 2013."  
"This study is an example of how cancer complexity often defies single-marker analysis in drug development," added Dr. Michael Pellini, president and CEO of Foundation Medicine. "We expect that our comprehensive genomic profile will help to identify the optimal patient population for AP26113 and may potentially enable an expedited development timeline."
Code: E121217

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