CAMBRIDGE, Mass. and SAN DIEGO, Dec. 21, 2015 /PRNewswire/ -- Foundation Medicine, Inc. (NASDAQ: FMI) and Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX), a targeted oncology company focusing on genetic and epigenetic drivers of cancer, today announced that they have entered into a collaboration for the development of a companion diagnostic test for glesatinib. The test, designed for use by physicians, will be used to identify NSCLC patients most likely to respond to Mirati's kinase inhibitor, glesatinib.
The companion diagnostic is part of a coordinated regulatory strategy and is being developed in parallel with the clinical development of glesatinib. The coordinated regulatory strategy is expected to facilitate a submission to the U.S. Food and Drug Administration (FDA) of a Premarket Approval (PMA) for the companion diagnostic, concurrent with the New Drug Application (NDA) for glesatinib. Patients with MET gene amplification and MET mutations are currently being enrolled in a Phase 2 trial of glesatinib. FoundationOne®, Foundation Medicine's comprehensive genomic profiling assay for solid tumors, is being used in the trial to identify those patients most likely to benefit from glesatinib based on patient genomic profiles, which will enable targeted recruitment of patient populations.
"We're pleased to work with Mirati as they advance glesatinib through the clinic, and to contribute to Mirati's efforts to advance patient care through precision medicine," said Steven Kafka, Ph.D., president and COO, Foundation Medicine. "Our collaboration with Mirati is an example of the growing demand for companion diagnostics that rely upon comprehensive genomic profiling. Importantly, this collaboration also represents significant progress in advancing Foundation Medicine's development of a universal companion diagnostic, a validated assay that streamlines and simplifies clinical decisions by providing all the necessary genomic information to help physicians target relevant cancer therapeutics with a single assay."
"Mirati treats cancer as a genetic disease. Often referred to as targeted oncology, this approach means we must find the genetic alterations responsible for driving cancer growth, like MET and Axl alterations, and block the activity of those targets. An effective patient selection strategy is a critical part of this process," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "In collaboration with Foundation Medicine, we expect to develop a companion diagnostic based upon their comprehensive genomic profiling assay that will detect all the relevant mutations in a single assay from a single biopsy, and provide patients with data to make the best treatment decisions. Identifying and treating the more than 15,000 non-small cell lung cancer patients in the U.S. who are most likely to respond to glesatinib may result in significantly improved patient outcomes."
About Glesatinib (MGCD265) Glesatinib (MGCD265) is a tyrosine kinase inhibitor that is expected to potently and selectively target tumors in patients with driver alterations in MET (mutations and gene amplification) and Axl (rearrangements) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). Glesatinib is being evaluated in a Phase 1b study in patients with solid tumors that have genetic alterations in MET or AXL genes. The Phase 2 trial in NSCLC patients with MET genetic alterations is underway to confirm and extend the data that supports the clinical benefit of glesatinib in patients with driver mutations in MET. Genetic alterations in these targets have been implicated as drivers of tumor growth and disease progression in NSCLC, gastroesophageal cancer and other solid tumors. MET and Axl are also implicated as drivers of tumor progression in patients whose tumors have become resistant to EGFR inhibitors. Therefore, Mirati believes that the combination of glesatinib with an EGFR inhibitor could potentially treat patients who have become resistant to agents targeting EGFR. Mirati retains worldwide rights to glesatinib.
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's clinical assays, FoundationOne® for solid tumors and FoundationOne® Heme for hematologic malignancies and sarcomas, provide a comprehensive genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies 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).
About Mirati Therapeutics Mirati Therapeutics develops molecularly targeted, single agent and immuno-oncology combination therapies intended to treat cancer. Mirati's approach combines the three most important factors in oncology drug development, 1) researching and developing drug candidates that target genetic and epigenetic drivers of cancer, 2) designing creative and agile clinical development strategies that select for patients whose tumors are dependent on specific driver alterations, and 3) leveraging a highly accomplished targeted oncology leadership team. The Mirati team uses a blueprint – proven by their prior work – for developing potential breakthrough cancer therapies, with accelerated development paths, in order to improve outcomes for patients. Mirati is advancing three drug candidates through clinical development for multiple oncology indications. More information is available at www.mirati.com.
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 the development of a companion diagnostic for glesatinib (MGCD265), the development of a universal companion diagnostic test, and the ability of FoundationOne to enable targeted recruitment of certain patient populations. 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 risk that the collaboration between FMI and Mirati does not progress as expected; and the risks described under the caption "Risk Factors" in Foundation Medicine's Quarterly Report on Form 10-Q for the three months ended March 31, 2015, which is on file with the Securities and Exchange Commission, as well as other risks detailed in 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.
Mirati Forward Looking Statements Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, contain "forward-looking" statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that involve significant risks and uncertainties. For more detailed disclosures and discussions regarding such forward looking statements, please refer to Mirati's filings with the U.S. Securities and Exchange Commission ("SEC"), including without limitation Mirati's filings on Forms 10-K, 10-Q, and 8-K. Forward looking statements are based on the current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it. Such statements can usually be identified by the use of words such as "may," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology, or by statements that certain actions, events or results "may" or "would" be taken, occur or be achieved. Such statements include, but are not limited to, statements regarding Mirati's development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati's product candidates. Forward looking statements involve significant risks and uncertainties and are neither a prediction nor a guarantee that future events or circumstances will occur. Such risks include, but are not limited to, potential delays in development timelines or negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks described in Mirati's filings with the SEC. We are including this cautionary note to make applicable, and to take advantage of, the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The information in this news release is given as of the date above and Mirati expressly disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
SOURCE Mirati Therapeutics, Inc.