Guardant Health And Mirati Therapeutics Enter Into Collaboration On Glesatinib (MGCD265) In Non Small Cell Lung Cancer (NSCLC) Trial

Mirati to Use Guardant360® Circulating Tumor DNA Diagnostic Test for Glesatinib Patient Selection and Explore the Development of Guardant360® as a Companion Diagnostic Assay

Dec 21, 2015, 08:16 ET from Mirati Therapeutics, Inc.

REDWOOD CITY, Calif. and SAN DIEGO, Dec. 21, 2015 /PRNewswire/ -- Guardant Health, the market leader in liquid biopsies, and Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX), a targeted oncology company focusing on genetic and epigenetic drivers of cancer, announced today that they have entered into a collaboration for the development of a circulating tumor DNA (ctDNA) assay for Mirati's kinase inhibitor, glesatinib.

Guardant360 is a blood test that identifies multiple tumor mutations across all four types of genomic alterations: single nucleotide variations, copy number amplifications, indels, and fusions. As part of the collaboration with Mirati, Guardant360 will be used to screen NSCLC patients for certain genetic alterations to the MET pathway in order to identify the patients most likely to respond to glesatinib. Specifically, the assay will sequence for patients with certain MET mutations and MET gene amplification. This plasma-based assay offers a less invasive, and potentially safer, approach to assess tumor genetics by avoiding the risks associated with tumor biopsies. This is an important factor for lung cancer patients for whom repeated tumor biopsies are often not possible. The ability to perform multiple ctDNA blood assays will also facilitate the identification of key resistance mechanisms.

The collaboration will use Guardant360 in Mirati's Phase 2 clinical trial of glesatinib in patients with NSCLC. In a separate press release today, Mirati announced the initiation of the Phase 2 trial. If successful, the collaboration could result in a regulatory submission and approval of the Guardant360 platform as a companion diagnostic for glesatinib.

"Guardant360 is particularly useful for cancers driven by evolved mutations like MET amplifications. The non-invasive assay allows oncologists to quickly and easily monitor patients and their response to targeted therapies," said Guardant Health co-founder and CEO, Helmy Eltoukhy. "Mirati is a pioneer in the field of targeted therapeutics and the company is known for being an innovator. Today's collaboration will allow us to leverage our unique technology to provide more patients access to targeted trials, and potentially accelerate clinical studies, making cancer a more manageable disease."

"Identifying patients with MET mutations or MET gene amplification is the key to our patient selection strategy. Clinical data has shown that these are the patients most likely to respond to glesatinib," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "Collaborating with Guardant on a ctDNA assay means that we expect to be able to detect these mutations in a blood sample. This will enable the more than 30% of non-small cell lung cancer patients, who have insufficient tumor tissue for biopsy, to be screened for genetic alterations that may be driving their cancer and to seek treatment that could lead to improved 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 Guardant360 Guardant360 is the first CLIA/CAP-certified comprehensive next generation sequencing-based liquid biopsy test indicated for cancer genomics. The 70-gene blood test is used in advanced cancer patients with visceral solid tumor cancers or metastases, and interrogates all four types of genomic alterations. The test is used to prevent repeat invasive biopsies when cancer has progressed or recurred despite treatment, or when an initial biopsy is unobtainable or has insufficient tissue. It is the only ctDNA test that includes all NCCN somatic genomic targets in a single test. Unlike hotspot tests, Guardant360 sequences complete exons so as not to miss uncommon or rare mutations. Based on the tumor genomic profile, clinicians receive a report of actionable genomic alterations and a list of FDA-approved treatments and clinical trials for which the patient could be eligible. Guardant360 has undergone extensive analytical and clinical validation and is supported by publications with leading cancer centers globally. 

About Guardant Health Guardant Health, headquartered in Redwood City, Calif., is focused on developing breakthrough diagnostics that can transform cancer from a silent killer into a manageable disease. Guardant Health was founded in 2012 by a team of serial entrepreneurs with expertise in next-generation sequencing, single-cell genomics, and cancer diagnostics. The company has raised $100 million in funding from leading venture capital firms and its first product, Guardant360, came to market in 2014. The team is committed to positively and significantly impacting patient health through technology that addresses long-standing unmet needs in oncology. 

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 oncology precision medicine 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.

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.



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