– Phase 1 Study will Assess First-in-Class
Switch-control ULK Kinase Inhibitor Designed to Inhibit Autophagy
as a Single Agent and in Combination with a MEK Inhibitor –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
announced dose administration for the first patient in the Phase 1,
multicenter, open-label, first-in-human study of DCC-3116. DCC-3116
is an investigational ULK kinase inhibitor designed to inhibit
autophagy and is being studied as a single agent and in combination
with trametinib, a U.S. Food and Drug Administration (FDA) approved
MEK inhibitor, in patients with advanced or metastatic tumors with
a mutant RAS or RAF gene.
“Approximately one third of all cancers, including a high
percentage of pancreatic, lung, colorectal, and melanoma cancers,
are driven by mutations in RAS or RAF genes, representing what we
believe to be one of the largest unmet medical needs in oncology,”
said Matthew L. Sherman, MD, Executive Vice President and Chief
Medical Officer of Deciphera Pharmaceuticals. “DCC-3116, a
first-in-class, highly selective switch-control ULK kinase
inhibitor, is designed to suppress autophagy and may offer a novel
approach to targeting a broad array of cancers. We look forward to
advancing our fourth active clinical development program generated
from our switch-control kinase inhibitor platform and further
evaluating the role of ULK kinase inhibition and its potential to
represent a new treatment paradigm for cancers caused by RAS or RAF
mutations.”
Autophagy, a catabolic process in which cells recycle components
to generate energy, is often upregulated in cancer cells when cells
are stressed or damaged due to anti-cancer treatments. The ULK
kinase initiates the autophagy pathway and provides a potential
targeted approach to selectively inhibiting autophagy in cancers
caused by RAS or RAF mutations. In preclinical studies, DCC-3116
was observed to potently and durably inhibit autophagy in RAS and
RAF mutant cancer cell lines through the inhibition of ULK kinase.
In addition, in preclinical studies, DCC-3116 also blocked the
increase in autophagy induced by inhibitors of the MAPK pathway as
a resistance mechanism. The Company’s in vitro and in vivo studies
have demonstrated that DCC-3116 in combination with inhibitors of
the MAPK pathway may block the growth of cancers caused by RAS or
RAF mutations.
The clinical development plan for DCC-3116 will focus on
documented RAS and RAF cancer mutations, which utilize autophagy
for tumor growth and survival. The Phase 1, multicenter,
open-label, first-in-human study will evaluate DCC-3116 as a single
agent and in combination with trametinib, an FDA-approved MEK
inhibitor, in patients with advanced or metastatic tumors with a
mutant RAS or RAF gene. Assuming positive results in the dose
escalation phase, combination expansion cohorts are currently
planned in patients with advanced or metastatic pancreatic ductal
adenocarcinoma (PDAC) with KRAS or BRAF mutations, non-small cell
lung cancer (NSCLC) with KRAS, NRAS, or BRAF mutations, colorectal
cancer (CRC) with KRAS, NRAS, or BRAF mutations, and melanoma with
NRAS or BRAF mutations. Combination expansion cohorts are planned
to evaluate DCC-3116 in combination with trametinib.
About Deciphera Pharmaceuticals
Deciphera is a biopharmaceutical company focused on discovering,
developing and commercializing important new medicines to improve
the lives of people with cancer. We are leveraging our proprietary
switch-control kinase inhibitor platform and deep expertise in
kinase biology to develop a broad portfolio of innovative
medicines. In addition to advancing multiple product candidates
from our platform in clinical studies, QINLOCK® is Deciphera’s
FDA-approved switch-control kinase inhibitor for the treatment of
fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also
approved for fourth-line GIST in Australia, Canada, China, and Hong
Kong. For more information, visit www.deciphera.com and follow us
on LinkedIn and Twitter (@Deciphera).
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including, without limitation, our expectations
regarding our belief that DCC-3116 may offer a novel approach to
targeting a broad array of cancers, ULK kinase inhibition’s
potential to represent a new treatment paradigm for cancers caused
by RAS or RAF cancers and a potential targeted approach to
selectively inhibiting autophagy in cancers caused by RAS or RAF
mutations, the DCC-3116/MAPK pathway inhibitor combination’s
potential to block the growth of cancers caused by RAS or RAF
mutations and our planned expansion cohorts. The words “may,”
“will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,”
“intend,” “believe,” “estimate,” “predict,” “project,” “potential,”
“continue,” “seek,” “target” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on
management’s current expectations and beliefs and are subject to a
number of risks, uncertainties and important factors that may cause
actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this
press release, including, without limitation, risks and
uncertainties related to the severity and duration of the impact of
COVID-19 on our business and operations, our ability to
successfully demonstrate the efficacy and safety of our drug
candidates and in additional indications for our existing drug, the
preclinical or clinical results for our product candidates, which
may not support further development of such product candidates, our
ability to manage our reliance on sole-source third parties such as
our third party drug substance and drug product contract
manufacturers, comments, feedback and actions of regulatory
agencies, our ability to commercialize QINLOCK and execute on our
marketing plans for any drugs or indications that may be approved
in the future, our ability to build and scale our operations to
support growth in additional geographies, the inherent uncertainty
in estimates of patient populations, competition from other
products, our ability to obtain and maintain reimbursement for any
approved product and the extent to which patient assistance
programs are utilized, our ability to comply with healthcare
regulations and laws, our ability to obtain, maintain and enforce
our intellectual property rights, any or all of which may affect
the initiation, timing and progress of clinical studies and the
timing of and our ability to obtain additional regulatory
approvals, and other risks identified in our Securities and
Exchange Commission (SEC) filings, including our Quarterly Report
on Form 10-Q for the quarter ended March 31, 2021, and subsequent
filings with the SEC. We caution you not to place undue reliance on
any forward-looking statements, which speak only as of the date
they are made. We disclaim any obligation to publicly update or
revise any such statements to reflect any change in expectations or
in events, conditions or circumstances on which any such statements
may be based, or that may affect the likelihood that actual results
will differ from those set forth in the forward-looking statements.
Any forward-looking statements contained in this press release
represent our views only as of the date hereof and should not be
relied upon as representing our views as of any subsequent date. We
explicitly disclaim any obligation to update any forward-looking
statements.
QINLOCK and the QINLOCK logo are registered trademarks, and
Deciphera and the Deciphera logo are trademarks, of Deciphera
Pharmaceuticals, LLC.
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version on businesswire.com: https://www.businesswire.com/news/home/20210630005186/en/
Investor Relations: Jen Robinson Deciphera Pharmaceuticals, Inc.
jrobinson@deciphera.com 781-906-1112
Media: David Rosen Argot Partners David.Rosen@argotpartners.com
212-600-1902
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