Mirati Therapeutics' Mocetinostat Included In Stand Up To Cancer's Cutting-Edge Clinical Trial Initiative For NSCLC Patients

SAN DIEGO, Oct. 12, 2017 /PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, announced today that the Company has been included in the SU2C Catalyst^TM program, a cutting-edge research initiative led by Stand Up To Cancer (SU2C) designed to bring innovative cancer treatments to patients quickly through novel collaborations between industry and academia.

A clinical trial research grant has been awarded to the Van Andel Research Institute (Grand Rapids, Michigan) to evaluate the potential of epigenetic agents to improve patient responses to immunotherapy in non-small cell lung cancer (NSCLC). The $2.5 million research grant will support a Phase 1/1b study combining Mirati's mocetinostat, an orally-bioavailable, spectrum-selective Class 1 & IV HDAC inhibitor, guadecitabine, a DNA methyltransferase (DNMT) inhibitor from Astex, and pembrolizumab, a PD-1 checkpoint inhibitor from Merck (known as MSD outside the U.S. and Canada). The grant is provided by Merck, a SU2C Catalyst Founding Supporter.

"We are honored to participate in this ground-breaking trial with pembrolizumab and guadecitabine. The combination of immunotherapy with epigenetic agents such as mocetinostat has great potential to positively impact outcomes for patients with NSCLC," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "The SU2C Catalyst program is an exceptional example of a collaboration designed to benefit cancer patients in an unprecedented way."

The team is led by Stephen Baylin, M.D., and Matthew Hellmann, M.D. Dr. Baylin is the co-director of the Cancer Biology Division and associate director for research programs for Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins as well as the co-leader of the VARI-SU2C Epigenetics Dream Team while Dr. Hellmann is an oncologist at Memorial Sloan Kettering Cancer Center in New York. Memorial Sloan Kettering will coordinate the trial with Dr. Hellmann as principal investigator.

"Despite the current and exciting advances with immune checkpoint therapy, many patients with NSCLC still do not receive benefit and this continues to be an extremely challenging disease. However, we remain optimistic that with continued research on the immune modulatory effects of epigenetic agents, the ability to test the hypothesis in trials like this, that these drugs combined with immune checkpoint therapy will contribute to improved ways to treat patients with NSCLC," said Dr. Baylin.

The trial is now open and enrolled its first patient in August 2017. Additional information on the trial can be found at https://clinicaltrials.gov/show/NCT03220477. For information on SU2C Catalyst and this project, visit SU2C.org.

Mirati is also conducting a Phase 2 study of mocetinostat in combination with durvalumab in NSCLC patients who have experienced progression of disease after treatment with checkpoint inhibitor therapy.  Patients are stratified into two cohorts based upon their best response to prior checkpoint therapy. Stage 1 of the study is currently enrolling nine patients in each cohort; one cohort has already met the prespecified criteria for expansion into stage 2 with at least one confirmed partial response.  Mirati will provide an update on this study by the end of the year.

About Mirati Therapeutics

Mirati Therapeutics is a clinical-stage oncology company developing targeted drugs to address the genetic, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who are most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where the ability of our drugs to improve the immune environment of tumor cells may enhance and expand the efficacy of existing immunotherapy medicines when given in combination. Our pre-clinical programs include potentially first-in-class and best-in-class drugs specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better drugs and better outcomes for patients.  For more information, visit www.mirati.com.

About Mocetinostat (MGCD103)

Mocetinostat (MGCD103) is an orally-bioavailable, spectrum-selective Class I & IV HDAC inhibitor. Class I HDAC inhibition of histone acetylation is predicted to enhance the recognition of tumor cells by anti-tumor T cells and reverse immunosuppressive factors in the tumor microenvironment. Epigenetic immunomodulation may enhance immune response to tumors, and ultimately improve patient response to immunotherapies. Mocetinostat is being studied in a Phase 2 trial as a combination therapy with durvalumab, targeting the programmed death ligand 1 (PD-L1) pathway, which has been implicated in advanced lung cancers.

Mirati retains worldwide rights to mocetinostat except for certain Asian territories where the program is partnered with Taiho.

About Stand Up To Cancer (SU2C)

Stand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, was established in 2008 by film and media leaders who utilize the industry's resources to engage the public in supporting a new, collaborative model of cancer research, and to increase awareness about cancer prevention as well as progress being made in the fight against the disease. As SU2C's scientific partner, the American Association for Cancer Research (AACR) and a Scientific Advisory Committee led by Nobel Laureate Phillip A. Sharp, PhD, conduct rigorous, competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and provide expert review of research progress. Current members of the SU2C Council of Founders and Advisors (CFA) include Katie Couric, Sherry Lansing, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, Ellen Ziffren, and Kathleen Lobb. The late Laura Ziskin and the late Noreen Fraser are also co-founders.  Sung Poblete, Ph.D., R.N., has served as SU2C's president since 2011.

For more information on Stand Up To Cancer, visit www.StandUpToCancer.org.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of the Company that are not historical facts may be considered "forward-looking statements," including, but 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 are typically, but not always, identified by the use of words such as "may," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology. Forward-looking statements are based on current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from the expectations set forth in the forward-looking statements. Such risks and uncertainties 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 detailed in Mirati's recent filings on Forms 10-K and 10-Q with the United States Securities and Exchange Commission. Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

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SOURCE Mirati Therapeutics, Inc.