Bristol-Myers Squibb and Illumina Announce Strategic Collaboration to Develop and Commercialize Companion Diagnostics for Bristol-Myers Squibb’s Oncology Immunotherapies

Expands Illumina’s Oncology Offerings for NextSeq™ 550Dx

A Diagnostic Version of the Illumina TruSight™ Oncology 500 Assay Will Measure Potentially Predictive Genomic Biomarkers, Including Tumor Mutation Burden

Category:

Friday, April 13, 2018 4:15 pm EDT

Dateline:

NEW YORK & SAN DIEGO

Public Company Information:

NASDAQ:
ILMN
US4523271090
NYSE:
BMY

NEW YORK & SAN DIEGO--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and Illumina, Inc. (NASDAQ: ILMN) today announced a collaboration that will utilize Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb’s oncology portfolio. The companies plan to develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure potentially predictive genomic biomarkers, including Tumor Mutation Burden (TMB). Illumina’s TruSight Oncology 500 assay is being developed to detect most of the known biomarkers for oncology therapeutics, including TMB and Microsatellite Instability for immunotherapies.

“Through our deep understanding of cancer biology and emerging research, we recognize the importance for physicians to know each patient’s biomarker status to help fight their cancer in a more personalized way,” said Saurabh Saha, M.D., Ph.D., Senior Vice President, Global Head of Translational Medicine, Bristol-Myers Squibb. “We are excited to partner with Illumina to pursue development of diagnostics that can help predict which patients will have the potential to benefit most from our immunotherapies.”

“The identification of biomarkers for targeted therapies is emerging as a key part of a cancer patient’s journey, from treatment selection through response monitoring and allows physicians to follow the evolution of a patient’s tumor over time,” said Garret Hampton, Ph.D., Executive Vice President of Clinical Genomics at Illumina. “Next-generation sequencing assays, such as a companion diagnostic (CDx) version of TruSight Oncology 500, are ideally suited to the comprehensive interrogation of a patient’s cancer. With BMS’ leading position in immunotherapy development, we see tremendous promise in this partnership to co-develop next-generation sequencing-based diagnostics that can identify effective therapeutic combinations and provide global access to these targeted drugs.”

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. Bristol-Myers Squibb’s clinical development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, has identified a number of potentially predictive biomarkers, including PD-L1, TMB, MSI-H/dMMR and LAG-3.

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 for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 24 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O radiation therapies across multiple tumors and potentially deliver the next wave of therapies 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 how patients’ tumor biology can be used as a guide for treatment decisions throughout their journey.

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, biotech and diagnostic 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 Illumina

Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com/cdx and follow @illumina.

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. Among other risks, there can be no guarantee that any companion diagnostic will be successfully developed through the collaboration with Illumina for any of the indications described in this release. 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, 2017 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.

Illumina Forward-Looking Statement This release contains projections, information about our financial outlook, earnings guidance, and other forward-looking statements that involve risks and uncertainties. These forward-looking statements are based on our expectations as of the date of this release and may differ materially from actual future events or results. Among the important factors that could cause actual results to differ materially from those in any forward-looking statements are (i) our ability to further develop and commercialize our instruments and consumables and to deploy new products, including diagnostic assays, services and applications, and expand the markets for our technology platforms; (ii) our ability to manufacture robust instrumentation, consumables, including diagnostic assays; (iii) our ability to successfully identify and integrate acquired technologies, products or businesses; (iv) the future conduct and growth of the business and the markets in which we operate; (v) challenges inherent in developing, manufacturing, and launching new products and services; (vi) our ability to obtain necessary regulatory approvals to market and sell diagnostic or therapeutic products and (vii) the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts’ expectations, or to provide interim reports or updates on the progress of the current quarter.

Contact:

Bristol-Myers Squibb
Ken Dominski, 609-252-5251
ken.dominski@bms.com
or
Investors:
Tim Power, 609-252-7509
timothy.power@bms.com
or
Bill Szablewski, 609-252-5894
william.szablewski@bms.com
or
Illumina
Lisa Warshaw, 323-360-8778
pr@illumina.com
or
Investors:
Jacquie Ross, CFA, 858-882-2172
ir@illumina.com

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