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 CatalystTM 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.