SAN DIEGO, May 19, 2016 /PRNewswire/ -- Mirati
Therapeutics, Inc. (NASDAQ: MRTX) today announced that abstracts on
its investigational tyrosine kinase inhibitor candidates,
glesatinib (MGCD265) and sitravatinib (MGCD516), will be presented
at the 2016 American Society of Clinical Oncology (ASCO) Annual
Meeting to be held in Chicago, IL
from June 3-7, 2016.
"We are excited to highlight several of the recent advancements
from our maturing clinical pipeline during these presentations at
the 2016 ASCO Annual Meeting," said Charles
Baum, M.D., Ph.D., CEO of Mirati. "We also plan to provide
an update on our three ongoing clinical programs during ASCO,
including progress made in the Phase 1b and Phase 2 trials in
glesatinib, the Phase 1b trial in sitravatinib, and the Phase 2
trial in mocetinostat. We look forward to delivering further
updates and additional data for each of our targeted oncology
candidates in late 2016."
Ongoing clinical work from both programs will be highlighted
during the following poster and publication sessions:
- Abstract No. TPS9099: "Amethyst NSCLC trial: Phase 2,
parallel-arm study of receptor tyrosine kinase (RTK) inhibitor,
MGCD265, in patients (pts) with advanced or metastatic non-small
cell lung cancer (NSCLC) with activating genetic alterations in
mesenchymal-epithelial transition factor (MET)"
Presenting Author: Igor
Rybkin
Session: Lung Cancer – Non-Small Cell Metastatic
Time/Location: Saturday, June 4,
2016 from 8:00 – 11:30 AM CT
in Hall A
Summary: The abstract provides an overview of the protocol
for this ongoing Phase 2 study. NSCLC patients with driver
alterations in MET are enrolled in one of four study arms, based on
the type of MET dysregulation and where it is detected, and are
then treated with MGCD265 in 21-day cycles until RECIST-defined
progression or unacceptable toxicity. The primary endpoint is
Objective Response Rate (ORR), with secondary objectives including
safety and tolerability; secondary efficacy endpoints; correlations
between tissue and blood testing; and pharmacokinetics (PK) and
pharmacodynamics (PD).
- Abstract No. 2575: "A first in human phase 1 study of
receptor tyrosine kinase (RTK) inhibitor MGCD516 in patients with
advanced solid tumors"
Presenting Author: Todd Michael
Bauer
Session: Developmental Therapeutics – Clinical Pharmacology
and Experimental Therapeutics
Time/Location: Sunday, June 5,
2016 from 8:00 – 11:30 AM CT
in Hall A
Summary: The abstract highlights a Phase 1 study in which 32
patients with advanced solid tumors received either 10, 20, 40, 80,
110, 150 or 200mg of MGCD516, first to establish an initial PK
profile and then for continuous daily dosing (QD) in 21-day cycles.
The primary objectives include evaluation for safety, PK/PD, the
maximum tolerated dose and clinical activity of MGCD516 in patients
with advanced solid tumors. The Phase 1b dose for MGCD516 was
established at 150mg QD, and MGCD516 shows favorable PK
characteristics, on-target PD effects and is associated primarily
with constitutional or GI-related AEs. A Phase 1b portion of the
study is currently being enrolled in patients with NSCLC or other
solid tumors with specific genetic alterations in MGCD516 target
RTK genes.
- Abstract No. e14087: "Evaluation of a
spray-dried dispersion (SDD) formulation of MGCD265, a receptor
tyrosine kinase (RTK) inhibitor, in a phase 1 study of patients
(pts) with advanced solid tumors."
Lead Author: Sunil Sharma
Session: Publication only
Summary: The abstract highlights the evaluation of an SDD
formulation of MGCD265 within an ongoing Phase 1 trial of MGCD265
in patients with solid advanced tumors. Eighteen patients were
treated with MGCD265 using either softgel capsules (12 patients) or
SDD tablets (six patients) in 21-day cycles to evaluate the maximum
tolerated dose/recommended Phase 2 dose. The SDD tablet formulation
of MGCD265 showed similar PK characteristics to the softgel capsule
formulation, but with greater bioavailability – thus reducing the
pill burden – and a more favorable safety profile to date.
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 Sitravatinib (MGCD516)
Sitravatinib (MGCD516) is
being evaluated in a Phase 1b dose expansion cohort in selected
patients with specific genetic alterations that are drivers of
tumor growth. The initial focus for MGCD516 is on NSCLC. MGCD516 is
a tyrosine kinase inhibitor that has demonstrated potent inhibition
of a closely related spectrum of tyrosine kinases, including RET,
CBL, CH4q12, DDR and Trk, which are key regulators of signaling
pathways that lead to cell growth, survival and tumor progression.
MGCD516 is also expected to target other signaling pathways that
may play a role in tumor growth. These 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. Mirati retains worldwide rights
to
sitravatinib.
About Mirati Therapeutics
Mirati Therapeutics
develops molecularly targeted therapies intended to treat cancer by
combining the three most important factors in oncology drug
development: 1) researching and developing drug candidates that
target genetic and epigenetic drivers of cancer as single agents
and in combination, including combination with immune therapy, 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 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.
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.
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SOURCE Mirati Therapeutics, Inc.