Paving the way to personalized medicine

CAMBRIDGE, Mass.—In what Dr. Michael J. Pellini, president andCEO of cancer diagnostics company Foundation Medicine Inc., describes as "aclear alignment between the companies in technology, expertise and innovation,"Foundation Medicine has announced a multiyear collaboration with AstraZenecaPLC to identify alterations found in cancer-related tumor genes that maypredict a person's response or resistance to targeted medicines. Thecollaboration will target all solid tumors.

"Together, we expect to enable a more individualized,targeted approach to cancer drug development and clinical trials," Pellinisays. "Foundation Medicine has a clear interest in working to help expand theuniverse of targeted therapeutic options—more therapeutics make our fullyinformative genomic profile increasingly actionable, and AstraZeneca haslaunched some of the most high-impact new targeted therapeutics for cancer."

Foundation Medicine has opportunities to develop andcommercialize potential diagnostic products. Under the terms of thecollaboration, Foundation Medicine was also granted right of first negotiationfor the development of potential diagnostic products.

"AstraZeneca has a firm commitment to personalizedhealthcare, and Foundation Medicine has quickly become a partner of choice inthis space, so it makes good sense for us to work together," adds SusanGalbraith, vice president and head of the Oncology Innovative Medicines unit atAstraZeneca. "There are several examples of oncology compounds in the pipeline,based on data that has emerged this year, which identify groups of patientsthat respond better to specific drugs. These include selumetinib in non-smallcell lung cancer and olaparib in genetic BRCA ovarian cancer."

This is the fourth such collaboration this year forFoundation Medicine, which was founded in 2010 by experts in genome technology,cancer biology and medical oncology from the Broad Institute, Dana-FarberCancer Institute, Harvard Medical School and MIT. The partnering vein that runsthrough AstraZeneca's R&D organization applies to personalized healthcareas well, as the company has more than 36 collaborations—half biotech and halfacademic—established in this space, according to Galbraith.

Initially, Foundation Medicine will use its comprehensivegenomic assay to look retrospectively at patient samples from an AstraZenecaclinical trial to identify genomic patterns. These results may help AstraZenecato research new medicines for people with cancer.

Foundation Medicine is a molecular information companydedicated to a transformation in cancer care in which treatment is informed bya deep understanding of the genomic changes that contribute to each patient'sunique cancer, according to Pellini. The company has developed a fullyinformative genomic profile to identify a patient's individual molecular alterationsand match them with relevant targeted therapies and clinical trials.

"Foundation Medicine's molecular information platform aimsto improve day-to-day care for patients by serving the needs of clinicians,academic researchers and drug developers to help advance the science ofmolecular medicine in cancer," he says.

AstraZeneca has a dedicated personalized healthcare teamwithin its R&D organization. Developing ways to identify and validatespecific markers that can be used by drug project teams to segment patientgroups for particular therapies, the team takes these markers through theanalytical validation stage, then shares them with external partners to bedeveloped into actual diagnostic tools.

"Cancer is the most advanced therapeutic area for ourpersonalized healthcare team, and about half their work is with oncology,followed by asthma and inflammation," Galbraith says. "In the coming year, weexpect to make decisions about whether two drugs will enter into Phase IIIdevelopment with companion diagnostics, and we are hopeful we will see more inthe future."

As to how the collaboration will pave the way topersonalized medicine, Pellini says, "by identifying alterations found incancer-related tumor genes that may predict a person's response or resistanceto targeted medicines, we aim to find the right therapies for the rightpatients to attack their unique tumor."

Galbraith summarizes, "Even the most in-depth genomicprofile for a patient is only as actionable as the available and relevanttargeted therapies. We hope that the information gleaned from our collaborationwith Foundation Medicine will improve our ability to develop the rightmedicines for the right patient populations."

Foundation Medicine and ARIAD in genomic profiling pact

CAMBRIDGE, Mass.—On Nov. 12, Foundation Medicine Inc. andARIAD Pharmaceuticals Inc. announced a genomic profiling collaboration to studyAP26113, ARIAD's investigational dual-inhibitor of ALK and EGFR in patientswith non-small cell lung cancer and other cancers. Foundation Medicine willwork with ARIAD to generate genomic profile information for patients enrolledin ARIAD's ongoing Phase I/II trial, and this data will be matched withclinical observations to understand the activity and selectivity profile ofAP26113.

"It is important that we have a deep molecular understandingof patients' tumors as they begin treatment with AP26113, especially thosepatients with complex prior treatment histories," stated Dr. Timothy P.Clackson, president of research and development and chief scientific officer atARIAD. "Foundation Medicine is at the forefront of genomic profilingtechnologies that will provide molecular insights on a wide array of clinicallyrelevant tumor genes, including ALK and EGFR alteration status. We look forwardto collaborating on the AP26113 program as we move into anticipated pivotaltrial(s) in 2013."

"This study is an example of how cancer complexity oftendefies single-marker analysis in drug development," added Dr. Michael Pellini,president and CEO of Foundation Medicine. "We expect that our comprehensivegenomic profile will help to identify the optimal patient population forAP26113 and may potentially enable an expedited development timeline."