Foundation Medicine Partners with Repare Therapeutics for Genomic Profiling and Lunresertib Diagnostic Development

Foundation Medicine, Inc. has announced a collaboration with Repare Therapeutics, a clinical-stage precision oncology company. This partnership aims to provide genomic profiling for patients enrolled in Repare's MYTHIC study (NCT04855656). The study investigates the efficacy of lunresertib, a novel oral small molecule inhibitor, both as a standalone therapy and in combination with other treatments in specific patient groups defined by their genomic profiles. Additionally, the companies are exploring the potential of using FoundationOne®CDx, a comprehensive genomic profiling test, as a companion diagnostic tool for the lunresertib program.

Lunresertib, discovered by Repare, is a pioneering oral inhibitor targeting PKMYT1, a cancer-related protein. This molecule is particularly effective against tumors with alterations such as CCNE1 amplification, FBXW7, and PPP2R1A. The drug is under evaluation in several studies across the U.S., Canada, the EU, and the UK. Initial Phase 1 data have shown promising safety and anti-tumor activity, providing proof of concept for lunresertib both alone and in combination with camonsertib, an ATR inhibitor from Repare currently in Phase 1/2 development.

The FoundationOne CDx test, approved by the U.S. Food and Drug Administration, analyzes over 300 cancer-related genes from a patient's tumor tissue sample. It has more than 35 companion diagnostic indications and is a globally recognized leader in next-generation sequencing testing. Foundation Medicine holds about 60% of all U.S. approvals for these types of tests.

Troy Schurr, Chief Biopharma Business Officer at Foundation Medicine, highlighted the importance of companion diagnostics. They are crucial for treatment decisions, especially in detecting complex biomarkers in patients lacking therapeutic options. He expressed pride in partnering with Repare Therapeutics to advance a potential first-in-class therapy for patients with significant unmet needs.

Foundation Medicine is a pioneer in molecular cancer profiling, committed to advancing clinical care and research. They collaborate with various partners in the cancer community, striving for excellence in quality, scientific innovation, and regulatory leadership. Their in-depth knowledge of cancer biology aids physicians in making informed treatment choices and assists researchers in developing new medications. Their mission is to help their partners find answers and take action, thereby enabling more people worldwide to benefit from precision cancer care.

FoundationOne CDx is a next-generation sequencing in vitro diagnostic device. It detects substitutions, insertions and deletions, copy number alterations in 324 genes, and certain gene rearrangements. It also identifies genomic signatures like microsatellite instability (MSI) and tumor mutational burden (TMB) from formalin-fixed, paraffin-embedded tumor tissue specimens. The test is for prescription use and serves as a companion diagnostic to identify patients who might benefit from targeted therapies based on their approved therapeutic product labeling. It also provides tumor mutation profiling, aiding healthcare professionals in oncology to make treatment decisions for patients with solid malignant neoplasms. However, a negative result does not rule out the presence of an alteration, and some patients may require a biopsy.

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