Partnership will focus on developing FoundationOne^®CDx as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828

Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, today announced a global collaboration with Boehringer Ingelheim to develop the company’s tissue-based comprehensive genomic profiling test, FoundationOne^®CDx, as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828, in the United States, Japan and European Union.

BI 907828 is an investigational, oral, small molecule MDM2-p53 antagonist. It is currently being evaluated as monotherapy in Brightline-2 (NCT05512377), an ongoing Phase IIa/IIb, open-label, single-arm, multi-center trial for the treatment of patients with locally advanced or metastatic, MDM2 amplified, TP53 wild-type biliary tract cancer in patients who have progressed on standard of care therapy.

“Biliary tract cancers are rare and aggressive cancers and those impacted have limited treatment options along with poor prognosis,” said Francesco di Marco, Senior Vice President, Head of Therapeutic Area Oncology, Boehringer Ingelheim. “At Boehringer Ingelheim, we take a diligent and broad approach in some of the most difficult, but potentially most impactful, areas of cancer. Foundation Medicine’s deep understanding of cancer biology and regulatory process makes them an ideal partner for us as we further investigate the role of the MDM2-p53 pathway in cancer development. Our hope is that through this collaboration, we will be able to address the challenges these patients continue to face.”

Comprehensive genomic profiling is emerging as an important tool in the treatment of biliary tract cancer given the rapidly evolving therapeutic landscape in this disease area.¹ Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests, offering physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions.

“High quality, well-validated genomic testing is critical to identify biliary tract cancer patients with complex alterations like MDM2 amplifications,” said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. “We’re proud to partner with Boehringer Ingelheim as they advance this investigational therapy and if approved, create access to it through companion diagnostic development.”

To learn more about Foundation Medicine and Boehringer Ingelheim’s collaboration, visit here.

About Foundation Medicine: Your Essential Partner in Cancer Care

Foundation Medicine is a pioneer in molecular profiling for cancer, working to shape the future of clinical care and research. We collaborate with a broad range of partners across the cancer community and strive to set the standard for quality, scientific excellence, and regulatory leadership. Our deep understanding of cancer biology helps physicians make informed treatment decisions for their patients and empowers researchers to develop new medicines. Every day, we are driven to help our partners find answers and take action, enabling more people around the world to benefit from precision cancer care. For more information, please visit us on www.FoundationMedicine.com and follow us on Twitter and LinkedIn.

About FoundationOne^®CDx

FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. FoundationOne CDx is for prescription use only and is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx.

Foundation Medicine^® and FoundationOne^® are registered trademarks of Foundation Medicine, Inc.

Source: Foundation Medicine

¹ DiPeri TP, Javle MM, Meric-Bernstam F. Next generation sequencing for biliary tract cancers. Expert Rev Gastroenterol Hepatol. 2021 May;15(5):471-474. doi: 10.1080/17474124.2021.1896967. Epub 2021 Mar 10. PMID: 33641586; PMCID: PMC8172427.

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