– Launch of QINLOCK® in Germany Underway;
Transition to Post-approval Paid Access Program in France Expected
in 1H 2022 –
– Pivotal Phase 3 MOTION Study of Vimseltinib
in TGCT Patients Underway; Updated Phase 1/2 Data Expected in 2H
2022 –
– Phase 1 Dose Escalation Data for DCC-3116
Expected in 2H 2022 –
– New Pan-RAF Research Program Disclosed;
Development Candidate Expected in 2022 –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
commercial-stage biopharmaceutical company developing innovative
medicines to improve the lives of people with cancer, today
provided a corporate update and highlighted key 2022 milestones in
conjunction with its presentation at the 40th Annual J.P. Morgan
Healthcare Conference. The Company will webcast its presentation
today at 9:00 AM ET at
https://investors.deciphera.com/events-presentations.
“Deciphera is well-positioned as we enter 2022 with multiple
high-value clinical programs and a successful commercial franchise
in QINLOCK, all generated by our proven and productive research
engine,” said Steve Hoerter, President and Chief Executive Officer
of Deciphera Pharmaceuticals. “We are excited about our leading
portfolio of novel kinase inhibitors, including our first-in-class
autophagy pathway inhibitor, DCC-3116, and our newly disclosed
pan-RAF research program, both of which seek to address the
challenges of drug resistance in patients with cancer. We believe
that DCC-3116, designed to inhibit the autophagy pathway by
inhibiting the ULK kinase, has the potential to address a broad
range of human cancers, and planning is now underway to expand this
development program to include a KRAS G12C inhibitor combination in
non-small cell lung cancer (NSCLC). We plan to present initial data
from the single agent dose escalation portion of this Phase 1 study
later this year. We also announced today our plans to nominate a
new clinical development candidate from our pan-RAF research
program later this year, which we believe has the potential to be a
best-in-class agent that can address unmet medical needs as a
single agent and in combination.”
Mr. Hoerter continued, “We kicked off 2022 with the launch of
QINLOCK in Germany and we plan to transition to a post-approval
paid access program in France in the first half of this year. Our
existing QINLOCK commercial footprint with sarcoma specialists also
serves as an excellent foundation for the future commercialization
of our potential best-in-class CSF1R inhibitor, vimseltinib. The
Phase 3 MOTION study of vimseltinib in tenosynovial giant cell
tumor (TGCT) is currently underway and we expect to present updated
data from our Phase 1/2 study in patients with TGCT later this
year.”
In 2022, the Company seeks to achieve the following
milestones:
QINLOCK® (ripretinib)
- Execute on the commercial launch of QINLOCK in fourth-line GIST
in Germany. Launch in Germany is ongoing as of January 1,
2022.
- Transition to post-approval paid access program in France in
the first half of 2022.
- Present results of the Phase 3 INTRIGUE study in second-line
GIST at the American Society of Clinical Oncology (ASCO) Plenary
Series Session on January 25, 2022.
Vimseltinib
- Enrollment underway in the Phase 3 MOTION study of vimseltinib,
an orally administered, potent, and highly selective switch-control
kinase inhibitor of CSF1R, for the treatment of TGCT.
- Present updated data from the Phase 1/2 study in TGCT patients
in the second half of 2022.
DCC-3116
- Present data from the single agent dose escalation portion of
this Phase 1 study of DCC-3116, a first-in-class ULK kinase
inhibitor designed to inhibit autophagy for the treatment of
patients with advanced or metastatic tumors with a mutant a RAS or
RAF gene, in the second half of 2022. DCC-3116 is currently being
investigated as a single agent and in combination.
- Initiate Phase 1 study dose expansion in the second half of
2022 in combination with trametinib, a U.S. Food and Drug
Administration-approved MEK inhibitor, in patients with selected
mutations in advanced or metastatic pancreatic ductal
adenocarcinoma, NSCLC, colorectal cancer, and melanoma.
- Planning underway to add a combination with a KRAS G12C
inhibitor in NSCLC to the ongoing Phase 1 study, subject to
feedback from regulatory authorities.
- Present additional preclinical data for DCC-3116 in 2022 and
continue to explore preclinical combinations of DCC-3116 with
multiple additional targeted oncology agents with diverse
mechanisms of action.
Proprietary Drug Discovery Platform
- Nominate a development candidate in 2022 from the pan-RAF
inhibitor research program, discovered using the Company’s novel
switch-control inhibitor platform.
Presentation at the 40th Annual J.P. Morgan Healthcare
Conference
Deciphera will webcast its corporate presentation from the 40th
Annual J.P. Morgan Healthcare Conference on Monday, January 10,
2022 at 9:00 AM ET. A live webcast of the presentation can be
accessed under “Events & Presentations” in the investors
section of the Company’s website at deciphera.com. A replay of the
webcast will be archived on the Company’s website for 90 days
following the presentation. In conjunction with the conference, the
Company has also updated its corporate presentation, which can be
found here:
https://investors.deciphera.com/events-presentations.
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
switch control inhibitor for the treatment of fourth-line GIST.
QINLOCK is approved in Australia, Canada, China, the European
Union, Hong Kong, Switzerland, Taiwan, the United Kingdom, and the
United States. 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
and timing regarding vimseltinib and enrollment for the pivotal
Phase 3 MOTION study in TGCT patients, the potential for
vimseltinib to be a best-in-class treatment for TGCT, presenting
updated vimseltinib data from our phase 1/2 study in TGCT patients,
initial data from the dose escalation phase of the Phase 1 study of
DCC-3116, plans to initiate the trametinib combination dose
expansion portion of the Phase 1 study of DCC-3116, plans to expand
the ongoing Phase 1 study of DCC-3116 to add a combination with a
mutant KRAS G12C inhibitor in NSCLC patients subject to feedback
from regulatory authorities, plans to present additional
pre-clinical data for DCC-3116, exploration of additional
pre-clinical combinations of DCC-3116, our belief that DCC-3116 has
the potential to address a broad range of human cancers, nominating
a development candidate for our pan-RAF research program, plans to
continue to establish QINLOCK as the fourth-line standard of care
in the U.S. and key European markets, ex-U.S. strategies including
executing on our commercial launch of QINLOCK in fourth-line GIST
in Germany and our plans to transition to a post-approval paid
access program in France and our plans to present INTRIGUE data for
our second-line GIST study for QINLOCK at the ASCO plenary session
in January 2022. 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
our ability to provide access to QINLOCK in European countries
other than Germany and France through other channels, 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 or drug candidates, the preclinical or
clinical results for our product candidates, which may not support
further development of such product candidates, 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, 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 and other risks identified in our Securities
and Exchange Commission (SEC) filings, including our Quarterly
Report on Form 10-Q for the quarter ended September 30, 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.
Deciphera, the Deciphera logo, QINLOCK, and the QINLOCK logo are
registered trademarks of Deciphera Pharmaceuticals, LLC.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220110005233/en/
Investor Relations: Maghan Meyers Argot Partners
Deciphera@argotpartners.com 212-600-1902
Media: David Rosen Argot Partners
David.Rosen@argotpartners.com 212-600-1902
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