– DCC-3116 Was Well-tolerated with No Dose
Limiting Toxicities or Treatment-Related Serious Adverse Events
Observed –
– Pharmacokinetic and Pharmacodynamic Data
Across all Doses Levels Demonstrated Exposure and ULK 1/2
Inhibition Associated with Anti-cancer Efficacy in Preclinical
Studies –
– Selection of Starting Dose and Initiation of
Combination Dose Escalation Cohorts with MEK and KRASG12C
Inhibitors Expected in Fourth Quarter 2022 –
– Company to Host Virtual Investor Event
Sunday, September 11 at 7:30 AM ET/ 1:30 PM CEST –
Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a
biopharmaceutical company focused on discovering, developing, and
commercializing important new medicines to improve the lives of
people with cancer, today announced positive initial data from the
single agent dose escalation portion of the Phase 1 study of
DCC-3116, the Company’s first-in-class, potent, and selective small
molecule switch-control kinase inhibitor of ULK1/2, in patients
with advanced or metastatic tumors with a mutant RAS or RAF gene.
Results from the study were presented in an oral presentation as a
Proffered Paper titled “Initial monotherapy results of a phase 1
first‑in‑human study of ULK1/2 inhibitor DCC‑3116 alone and in
combination with MAPK pathway inhibition” at the ESMO Congress
2022.
“We are excited to report first-in-human DCC-3116 clinical data
demonstrating a favorable tolerability profile and
pharmacokinetics, and strong target inhibition across all dose
levels tested,” said Matthew L. Sherman, M.D., Chief Medical
Officer of Deciphera. “As the first ULK1/2 inhibitor to enter
clinical development, these positive initial results represent a
significant milestone as we prepare to initiate combination dose
escalation later this year. With a novel mechanism of action and
strong preclinical data demonstrating compelling anti-tumor
activity in combination with a broad array of RTK, RAS, and other
MAP kinase pathway inhibitors, we believe DCC-3116 has the
potential to open a new frontier in the treatment of cancer.”
Anthony Tolcher, M.D., FRCPC, Co-Founder and Director of
Clinical Research, NEXT Oncology said, “The initial DCC-3116
monotherapy results reported today are very encouraging and
strongly support the advancement of DCC-3116 into the combination
setting. The preliminary data show DCC-3116 to be a very
well-tolerated agent that has demonstrated strong target inhibition
of ULK 1/2 from even the lowest tested dose. I look forward to the
selection of the combination starting dose and advancing the
program into the first combination studies with MEK and KRASG12C
inhibitors.”
Summary of Data and Findings
As of June 9, 2022, 18 patients with locally advanced or
metastatic cancer with a RAF or RAS mutation were enrolled across
four cohorts dosed with DCC-3116 twice daily (BID): 50 mg BID
(n=3); 100 mg BID (n=4); 200 mg BID (n=7); and 300 mg BID (n=4).
The median number of prior anti-cancer regimens was three (range
1-10). The most common cancer types were colorectal (56%) and
pancreatic (28%) and patients had KRAS (83%) and BRAF (17%)
mutations.
The results of the primary objectives of safety and tolerability
as well as the additional objectives of pharmacokinetics,
pharmacodynamics, and anti-tumor activity are summarized below:
Safety and Tolerability:
- Treatment with DCC-3116 was well tolerated and most
treatment-emergent adverse events (TEAEs) were Grade 1/2; the most
common (≥15%) TEAEs regardless of relatedness reported (all grades)
were: fatigue (39%), dehydration (22%), alanine transaminase (ALT)
increases (17%), anemia (17%), aspartate transaminase (AST)
increases (17%), decreased appetite (17%), hyponatremia (17%),
nausea (17%), and vomiting (17%).
- No dose-limiting toxicities or treatment-related serious
adverse events were observed with DCC-3116; two asymptomatic,
reversible Grade 3 alanine transaminase increases that led to dose
interruption and reduction were reported as treatment-related.
Pharmacokinetics, Pharmacodynamics and Anti-Tumor Activity:
- DCC-3116 exposure appeared to increase dose-proportionally
across the four dose levels tested from 50 mg BID to 300 mg BID; at
all doses levels, the area under the curve (AUC) of DCC-3116 was at
or above the AUC of the lowest tested dose that was effective in
preclinical studies.
- DCC-3116 demonstrated target inhibition with significant
decreases in phosphorylation of ATG14, a direct ULK1/2 substrate,
in peripheral blood mononuclear cells; at all dose levels,
reductions in phosphorylated ATG14 were observed that were
associated with anti-tumor activity in preclinical studies
combining DCC-3116 and a MEK inhibitor as measured by reductions in
phosphorylated ATG13 in tumors.
- Fourteen patients were evaluable for response per Response
Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as of the
cutoff date; best overall response was stable disease and the
disease control rate at week 16 was 29%.
Dose cohorts 100 to 300 mg BID are being expanded to further
characterize the safety, pharmacokinetics, and pharmacodynamics of
DCC-3116. In the fourth quarter of 2022, we expect to select the
starting dose of DCC-3116 for, and initiate, dose escalation
cohorts in combination with MEK and KRASG12C inhibitors.
Conference Call and Webcast Deciphera will host a
conference call and webcast to discuss data presentations from the
Company’s DCC-3116 and vimseltinib clinical programs at the ESMO
Congress 2022 on Sunday, September 11, 2022, at 7:30 AM ET/ 1:30 PM
CEST. The event may be accessed by registering at
https://deciphera-pharmaceuticals.open-exchange.net/registration. A
webcast of the event will be available in the “Events and
Presentations” page in the “Investors” section of the Company’s
website at https://investors.deciphera.com/events-presentations.
The archived webcast will be available on the Company’s website
within 24 hours after the event and will be available for 30 days
following the event.
About DCC-3116 DCC-3116 is an investigational, orally
administered, potent, and highly selective switch-control inhibitor
designed to inhibit cancer autophagy, a key tumor survival
mechanism in cancer cells, by inhibiting the ULK1/2 kinases, which
have been shown to be the enzymes responsible for initiating
autophagy. DCC-3116 is currently being studied in a Phase 1/2,
multicenter, open-label, first-in-human study as a single agent and
in combination with RAS/MAPK pathway inhibitors in patients with
advanced or metastatic solid tumors with a RAS/MAPK pathway
mutation (NCT04892017).
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 the potential for DCC-3116 to be a first-in-class
treatment that opens a new frontier in the treatment of cancer, and
the selection of a starting dose for DCC-3116 for and the
initiation of combination dose escalation cohorts with MEK and KRAS
G12C inhibitors in the Phase 1 study of DCC-3116. 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 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 June 30, 2022 , 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220910005012/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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