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Mirati Therapeutics to Provide Updates on Pipeline Programs at 2015 ASCO Annual Meeting


SAN DIEGO, May 13, 2015 /PRNewswire/ -- Mirati Therapeutics, Inc. ("Mirati") (NASDAQ: MRTX) today announced that the Company will provide an update on its investigational targeted tyrosine kinase inhibitor candidates, MGCD265 and MGCD516, and spectrum-selective HDAC inhibitor, mocetinostat, at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting to be held in Chicago from May 29-June 2, 2015. The updates on MGCD265 will be presented as part of the developmental therapeutics category. MGCD516 and mocetinostat will be presented as clinical trials in progress.

"We are pleased to participate in the 2015 ASCO Annual Meeting and present the progress we have made with each of Mirati's targeted oncology candidates," said Charles M. Baum, M.D., Ph.D., president and CEO, Mirati. "We look forward to providing new insights concerning the scientific basis and clinical utility of our lead candidate, MGCD265, for patients with non-small cell lung cancer who are diagnosed with MET- or Axl-driven tumors."

Mirati Abstracts Being Presented at ASCO

  • Abstract # 2589: "Phase 1 Study of Receptor Tyrosine Kinase (RTK) Inhibitor, MGCD265, in Patients with Advanced Solid Tumors"
    Lead author: Christian Kollmannsberger, M.D., British Columbia Cancer Agency, Vancouver Cancer Centre
    Session: "Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics" poster session
    Time/Location: Saturday, May 30, 2015 from 8:00 - 11:30 AM CT (6:00 - 9:30 AM PT) in S Hall A


  • Abstract # TPS4575: "A Phase 2 Study of the Histone Deacetylase (HDAC) Inhibitor Mocetinostat in Patients with Urothelial Carcinoma and Inactivating Alterations of Acetyltransferase Genes"
    Lead Author: Noah M. Hahn, M.D., John Hopkins Kimmel Cancer Center
    Session: "Genitourinary (Nonprostate) Cancer" poster session
    Time/Location: Monday, June 1, 2015 from 1:15 - 4:45 PM CT (11:15 - 2:45 PM PT) in S Hall A


  • Abstract # TPS2621: "A First-in-Human Phase 1/1b Study of Receptor Tyrosine Kinase (RTK) Inhibitor, MGCD516, in Patients with Advanced Solid Tumors"
    Lead Author: Gary K. Schwartz, M.D., Columbia University Medical Center
    Session: "Developmental Therapeutics - Clinical Pharmacology and Experimental Therapeutics" poster session
    Time/Location: Saturday, May 30, 2015 from 8:00 - 11:30 AM CT (6:00 - 9:30 AM PT) in S Hall A

About MGCD265
MGCD265 is a tyrosine kinase inhibitor that is expected to potently and selectively target tumors in patients with driver mutations in MET (gene amplification and mutations) and Axl (fusions) that occur in approximately 8% of patients with non-small cell lung cancer (NSCLC). MGCD265 is in the expansion phase of a Phase 1/1b dose escalation study for NSCLC patients with MET or Axl genetic alterations. 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, the combination of MGCD265 with an EGFR inhibitor could treat patients who have become resistant to agents targeting EGFR. Mirati retains worldwide rights to MGCD265.

About Mocetinostat
Mocetinostat is an orally-bioavailable, spectrum-selective HDAC inhibitor. Mocetinostat is currently in a Phase 2 trial for the treatment of patients with bladder cancer that carry inactivating mutations of the histone acetyltransferase genes CREBBP and EP300. An investigator-sponsored Phase 2 study evaluating mocetinostat as a treatment for diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) is underway. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to mocetinostat as a treatment for DLBCL. Mirati retains worldwide rights to mocetinostat, with the exception of certain Asian territories where the program is partnered with Taiho Pharmaceutical Co., Ltd.

About MGCD516
MGCD516 is a tyrosine kinase inhibitor that has demonstrated potent inhibition of a closely related spectrum of tyrosine kinases including Trk, RET, and DDR which are key regulators of signaling pathways that lead to cell growth, survival and tumor progression. These kinases and their key regulatory pathways are genetically altered in multiple cancer indications and act as oncogenic drivers that promote cancer development and progression in solid tumors, including NSCLC. MGCD516 is in a Phase 1 dose escalation study in advanced solid tumors with an initial focus on NSCLC. Mirati retains worldwide rights to MGCD516.

About Mirati Therapeutics
Mirati Therapeutics develops molecularly targeted cancer treatments intended to inhibit tumor growth. 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

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.

Company Contact:
Anne Erickson
Mirati Therapeutics Inc.
Investor Relations and Corporate Communications

Investor Relations and Media Relations:
Jason Spark
Canale Communications


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SOURCE Mirati Therapeutics, Inc.

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