Foundation Medicine, Inc., today announced that it has formed a collaboration with Repare Therapeutics, a leading clinical-stage precision oncology company, to provide prospective genomic profiling to patients in Repare’s ongoing Phase I/Ib MYTHIC study (NCT04855656) of lunresertib alone or in combinations in genomically-defined patient populations. The companies are also exploring opportunities to develop FoundationOne^®CDx, a tissue-based comprehensive genomic profiling test, as a companion diagnostic for the lunresertib program.

Lunresertib is a first-in-class, selective and potent oral small molecule inhibitor of PKMYT1, a cancer target Repare discovered and identified as synthetic lethal with CCNE1 amplification, FBXW7 and PPP2R1A alterations in solid tumors. Lunresertib is being evaluated alone and in combinations across several studies in the United States, Canada, European Union and United Kingdom. Repare has presented positive initial Phase 1 data, including compelling safety and anti-tumor activity, demonstrating proof of concept for lunresertib alone and in combination with camonsertib, a potential best-in-class ATR inhibitor developed by Repare and in Phase 1/2 development.

Using a tissue sample, the U.S. Food and Drug Administration-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. The test currently has over 35 companion diagnostic indications. Foundation Medicine is the global leader in companion diagnostic approvals with approximately 60% of all U.S. companion diagnostic approvals for next generation sequencing testing.

“High-quality companion diagnostics are critical to inform treatment decisions, and they are especially important for detecting complex biomarkers in patients without any therapeutic options,” said Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine. “We’re proud to partner with Repare Therapeutics as they work to advance this potential first-in-class therapy for patients with high unmet need.”

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

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 X 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 www.F1CDxLabel.com.

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