From pilot to partners

Novartis, Foundation Medicine build on oncology genome analysis collaboration

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CAMBRIDGE, Mass.—Molecular information company FoundationMedicine recently announced the establishment of a new agreement with Novartis,under which Foundation Medicine will provide comprehensive genomic analysis forthe support of Novartis' clinical oncology program.
Per the agreement, Novartis will use Foundation Medicine'scomprehensive genomic profiling on most of the volunteers enrolled in itsoncology Phase I and Phase II clinical trials over the next three years. Thecollaboration will also work toward accelerating the development of Novartis'portfolio of cancer therapeutics in hopes of expanding treatment options forpatients. Additional details regarding financial terms and which of Novartis'specific cancer programs will be involved were not disclosed.
"The comprehensive molecular assessment of Novartis'oncology clinical trial samples is expected to help to bring potentiallylifesaving therapies to the right patients more quickly, and we expect that thewealth of molecular information will help fundamentally improve the way canceris understood and treated," Dr. Michael J. Pellini, president and CEO ofFoundation Medicine, said in a press release. "We are pleased to see ourcollaboration mature into a significant relationship between FoundationMedicine and Novartis."
The program has provided interesting data, the companiesnote, and Barbara Weber, senior vice president of Oncology TranslationalMedicine at the Novartis Institutes for BioMedical Research Inc., adds that theformat of tumor genome profiling "has become an essential component ofNovartis' clinical trials."
"Overall, we believe the Foundation Medicine molecularinformation platform offers an important step forward in understanding thegenomic profiling of each patient's cancer and will ultimately help us achieveour goal to bring the right treatment to the right patient across a broad rangeof cancers and hematologic diseases," says Weber.
The agreement is a continuation of Novartis' and FoundationMedicine's relationship, which was first established in January of this year.The companies announced a strategic pilot collaboration to develop, enhance andoptimize Foundation Medicine's cancer genome panel test to fit Novartis' needs,with the intent to evaluate future collaborations on production andcommercialization of the test if the pilot phase was successful. Alexis Borisy,CEO of Foundation Medicine, noted in a press release regarding the pilotcollaboration that it represented the company's first pharmaceuticalpartnership. No financial details were disclosed.
Foundation Medicine is striving to develop a comprehensivecancer diagnostic test, focusing on next-generation sequencing to garnerrelevant information to help doctors make more informed decisions for moreindividualized cancer care. The laboratory tests are designed "to accommodateand assimilate a dynamic landscape of cancer genome and other molecularinformation and growing availability of treatment options," the company notes,allowing doctors to compare each patient's unique "cancer-associatedaberrations" against existing genomic knowledge and available therapies.
The company's approach consists of using clinical-grade,next-generation sequencing to analyze hundreds of cancer-related genes informalin-fixed, paraffin-embedded tumor samples. Novartis' hope is to use thisapproach to align its enrollment for clinical trials and outcome analysis withthe genomic profiles of individual patient tumors. Foundation Medicine maydevelop additional diagnostic products resulting from its collaboration withNovartis.
The collaboration is Foundation Medicine's second in recentmonths, as the company announced another agreement with Array BioPharma onMarch 6. In the collaboration, Foundation Medicine's genomic sequencing will beapplied to evaluate potentially relevant molecular alterations that couldassist Array in determining which patients are most likely to respond totreatment. Array's portfolio includes several targeted cancer agents inearly-stage clinical development, and with the help of Foundation Medicine'sgenomic sequencing, Array hopes to determine the genetic profile of tumors frompatients who are treated with its anticancer agents. The objective is to gainunderstanding in how to identify which patients might respond to a giventherapy in yet another step toward more specific, individualized cancertreatment.

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