Bristol-Myers Squibb Company (NYSE:BMY) and Foundation Medicine (NASDAQ:FMI) today announced a collaboration that leverages Foundation Medicine’s comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) in patients enrolled across clinical trials investigating Bristol-Myers Squibb’s cancer immunotherapies. Biomarkers can be used to characterize a tumor and the tumor microenvironment, which may reveal immune-related mechanisms predictive of how a patient may respond to immunotherapy.

Cancer immunotherapy works by helping the immune system mount an anti-cancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Higher levels of tumor mutations have been shown to correlate to the number of neoantigens, and therefore may help identify patients more likely to respond to cancer immunotherapies. Foundation Medicine’s approach utilizing its FoundationOne® assay combines comprehensive genomic profiling with its advanced and proprietary algorithms to measure biomarkers, including TMB and MSI, without the need for whole exome sequencing.

“Translational medicine research is critical to further our understanding of cancer biology and to identify which patient populations are most likely to derive benefit from our Immuno-Oncology agents,” said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. “We believe this collaboration with Foundation Medicine will help us better understand the relation of genomic approaches to immunotherapy efficacy across a number of different tumor types and immunotherapy agents.”

“Cancer immuno-therapy is evolving rapidly, and biopharmaceutical companies and practicing oncologists alike may benefit from a reliable, validated, comprehensive view of mutational burden and genomic alterations to make the most informed care decisions,” said Melanie Nallicheri, chief business officer and head, Biopharma for Foundation Medicine. “Our collaboration with Bristol-Myers Squibb highlights the potential value of our molecular information platform to the biopharma industry for its ability to inform, to reduce risk and to accelerate clinical development in this high growth and highly competitive oncology field.”

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines that will raise survival expectations in hard-to-treat cancers and will change the way patients live with cancer.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational and approved agents, including the first combination of two I-O agents in metastatic melanoma, and our differentiated clinical development program, which is studying broad patient populations across more than 35 types of cancers with 13 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs uniquely position us to advance the science of combinations across multiple tumors and potentially deliver the next wave of I-O combination regimens with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and inform which patients will benefit most from I-O therapies.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube and Facebook .

About Foundation Medicine

Foundation Medicine (NASDAQ:FMI) 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. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies, immunotherapies 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. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Bristol-Myers Squibb Forward-looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2016 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Foundation Medicine Forward-Looking Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding a research and development collaboration between Bristol-Myers-Squibb and Foundation Medicine , the ability of FoundationOne to measure tumor mutational burden (TMB) and Microsatellite Instability (MSI), the conduct of clinical trials by Bristol-Myers-Squibb, and the utilization of FoundationOne in such clinical trials. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that the collaboration does not proceed or does not meet its objectives of the parties; FoundationOne is not an effective diagnostic test for measuring TMB or MSI; the clinical trials anticipated to be conducted by Bristol-Myers Squibb do not take place or FoundationOne is not utilized in such trials; and the risks described under the caption "Risk Factors" in Foundation Medicine's Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 2, 2017, as well as other risks detailed in Foundation Medicine's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.