SAN DIEGO, Nov. 8, 2018 /PRNewswire/ -- Mirati Therapeutics,
Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company,
today announced dosing of the first patient under its collaboration
agreement with BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) in a Phase
1b clinical trial to assess the
safety and tolerability, pharmacokinetics and preliminary
anti-tumor activity of Mirati's sitravatinib in combination with
BeiGene's investigational anti-PD1 antibody, tislelizumab, in
patients with advanced solid tumors. The clinical trial is
currently enrolling patients in China and Australia.
"We're excited to move into the next phase of our collaboration
with BeiGene. BeiGene's ability to rapidly enroll patients into
this clinical trial has the potential to significantly expand and
accelerate our development efforts for sitravatinib and provide
access to additional patient populations," said Charles Baum, M.D., Ph.D., President and Chief
Executive Officer of Mirati. "This clinical trial also has the
potential to provide proof of concept clinical data in multiple
solid tumor types."
This initial open-label, multicenter, non-randomized Phase
1b clinical trial is designed to
assess the safety and tolerability in patients with histologically
or cytologically confirmed locally advanced or metastatic
non-squamous, non-small cell lung cancer (NSCLC), renal cell
carcinoma, and ovarian cancer. Patients will receive 120 mg of oral
sitravatinib, daily, and 220 mg of intravenous tislelizumab, every
three weeks.
"This collaboration has progressed quickly, and we are pleased
that we can investigate the potential complementary activity of
sitravatinib and tislelizumab in patients with advanced solid
tumors in China and Australia," said Amy
Peterson, M.D., Chief Medical Officer, Immuno-Oncology at
BeiGene.
Under the terms of the collaboration agreement, upon initiation
of the clinical trial by BeiGene, Mirati will receive a
$3 million milestone payment.
About Sitravatinib
Sitravatinib is a spectrum-selective kinase inhibitor that
potently inhibits receptor tyrosine kinases (RTKs), including TAM
family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2,
KIT) and RET. As an immuno-oncology agent, sitravatinib is being
evaluated in combination with nivolumab (OPDIVO®), an
anti-PD-1 checkpoint inhibitor, in patients who have experienced
documented disease progression following treatment with a
checkpoint inhibitor. Sitravatinib's potent inhibition of TAM and
split family RTKs may overcome resistance to checkpoint inhibitor
therapy through targeted reversal of an immunosuppressive tumor
microenvironment, enhancing antigen-specific T cell response and
expanding dendritic cell-dependent antigen presentation.
Sitravatinib is also being evaluated as a single agent in a
Phase 1b expansion clinical trial
enrolling patients whose tumors harbor specific mutations in the
CBL protein. When CBL is inactivated by mutation, multiple RTKs,
including TAM, VEGFR2 and KIT, are dysregulated and may act as
oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib
potently inhibits these RTKs and is being investigated as a
treatment option for cancer patients with CBL mutations.
About Mirati Therapeutics
Mirati Therapeutics, Inc. is a clinical-stage oncology company
developing product candidates 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 we believe would be most
likely to benefit from targeted drug treatment. In immuno-oncology,
we are advancing clinical programs where our product candidates
have the potential to improve the immune environment of tumor cells
and may enhance and expand the efficacy of existing cancer
immunotherapy medicines when given in combination. Our pre-clinical
programs include potentially first-in-class and best-in-class
product candidates 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 therapies and better outcomes for patients. For more
information, visit www.mirati.com.
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 Mirati Therapeutics, Inc. ("Mirati") that are not
historical facts may be considered "forward-looking statements,"
including without limitation 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," "will,"
"would," "believe," "intend," "plan," "anticipate," "estimate,"
"expect," and other similar terminology indicating future results.
Forward-looking statements are based on current expectations of
management and on what management believes to be reasonable
assumptions based on information currently available to them, and
are subject to risks and uncertainties. Such risks and
uncertainties may cause actual results to differ materially from
those anticipated in the forward-looking statements. Such risks and
uncertainties include without limitation potential delays in
development timelines, 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 U.S. Securities and Exchange Commission. Except as
required by law, 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.