CAMBRIDGE, Mass., Sept. 13, 2021 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced the
Company will be presenting initial data from the first-line cohort
of the DisTinGuish study, a Phase 2a clinical trial evaluating
Leap's anti-Dickkopf-1 (DKK1)
antibody, DKN-01, in combination with tislelizumab, BeiGene Ltd.'s
anti-PD-1 antibody, and chemotherapy, in patients with gastric or
gastroesophageal junction cancer (G/GEJ), at the European Society
for Medical Oncology (ESMO) Congress, being held virtually on
September 16-21, 2021. The Company
will host a conference call on Friday,
September 17, 2021 to discuss preliminary results from the
study.
"Initial data from the DisTinGuish study is extremely promising
as it shows DKN-01 in combination with tislelizumab and
chemotherapy to have high response rates in first-line patients
suffering from gastric and gastroesophageal junction cancer," said
Cynthia Sirard, MD, Chief Medical
Officer of Leap. "Patients whose tumors have high levels of
DKK1 expression, which is known to
correlate with aggressive disease and poor prognosis, showed the
highest response rates, suggesting how important the biomarker may
be in predicting response to therapy. Additional data will be
presented at ESMO and in our conference call to demonstrate the
potential DKN-01 has as part of first-line therapy in this
difficult-to-treat indication."
About the DisTinGuish Study
The DisTinGuish study (NCT04363801) is a Phase 2a study of
DKN-01 in combination with tislelizumab, an anti-PD-1 antibody,
with or without chemotherapy as first-line or second-line therapy
in patients with inoperable, locally advanced, G/GEJ
adenocarcinoma. The study is being conducted in two parts, in
the United States and the Republic
of Korea. Enrollment of Part A has been completed with 25
first-line HER2- G/GEJ cancer patients whose tumors express either
high levels of DKK1 (DKK1-high) or low levels of DKK1 (DKK1-low).
Part B of the study will enroll up to 48 patients with second-line,
DKK1-high G/GEJ cancer. Leap is
conducting this combination study as part of an exclusive option
and license agreement with BeiGene for the development of DKN-01 in
Asia (excluding Japan), Australia, and New
Zealand.
Key Findings
- DKN-01 in combination with tislelizumab and chemotherapy
demonstrated compelling overall response rates (ORR) as a
first-line treatment for advanced G/GEJ cancer
- In the primary efficacy analysis, including all patients who
received a full cycle of DKN-01 therapy, the ORR was 68.2%, with
90% ORR in DKK1-high patients as
compared to a 56% ORR in DKK1-low
patients
- In the overall intent to treat population, including those
patients who did not receive a full cycle of therapy, the ORR was
60%, with 75% ORR in DKK1-high
patients as compared to a 56% ORR in DKK1-low patients
As of the date of the abstract, 13 patients had experienced a
partial response (PR), six patients had a best response of stable
disease (SD), one patient was non-evaluable for response (NE),
three patients were unable to complete a full cycle of therapy
(non-modified ITT (mITT)), and two patients were pending their
first tumor assessment. Of the 18 patients that had
RNAscope® DKK1 expression
available for the abstract, 9 were DKK1-high [6 PR, 1 NE, and 2 non-mITT] and 9 were
DKK1-low [5 PR, 4 SD]. Subsequent to
the date of the abstract, the two patients who were pending their
first scan for response to therapy were determined to have had PRs,
and three additional patients were determined to have had
DKK1-high tumors, each of whom
experienced a PR.
Further results will be presented at the ESMO 2021 Congress from
September 16 to 21, 2021.
Leap Presentation Details:
Title: DKN-01 in combination with tislelizumab and
chemotherapy as a first-line therapy in unselected patients with
advanced gastroesophageal adenocarcinoma (GEA): DisTinGuish
Trial
Abstract Number: 2218
Session type: E-Poster Presentation
Presenter: Samuel J.
Klempner, Harvard Medical
School
Date and time: Thursday, September
16, 2021; 2:30 a.m. ET
Conference Call
Leap will host a conference call on Friday, September 17, 2021 at 8:00 a.m. Eastern Time to further discuss the
data. In addition to Leap's executive management team, Dr
Jaffer Ajani of M.D. Anderson Cancer
Center and Dr. Samuel Klempner of
Massachusetts General Hospital will be on the call. The call can be
accessed by dialing (866) 589-0108 (U.S. and Canada) or (409) 231-2048 (international). The
passcode for the conference call is 1729397. The presentation will
be webcast live and may be accessed on the Investors page of the
Company's website at https://investors.leaptx.com/, where a replay
of the event will also be available for a limited time.
About Leap Therapeutics
Leap Therapeutics (Nasdaq: LPTX) is focused on developing
targeted and immuno-oncology therapeutics. Leap's most advanced
clinical candidate, DKN-01, is a humanized monoclonal antibody
targeting the Dickkopf-1 (DKK1)
protein. DKN-01 is in clinical trials in patients with
esophagogastric, hepatobiliary, gynecologic, and prostate cancers.
Leap has entered into a strategic partnership with BeiGene, Ltd.
for the rights to develop DKN-01 in Asia (excluding Japan), Australia, and New
Zealand. For more information about Leap Therapeutics, visit
http://www.leaptx.com or view our public filings with the SEC that
are available via EDGAR at http://www.sec.gov or via
https://investors.leaptx.com/.
RNAscope® is a registered trademark of Advanced Cell
Diagnostics, Inc., Newark, CA,
USA.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, Section 21E of the Securities Exchange Act of 1934, as
amended, and the Private Securities Litigation Reform Act of 1995,
which involve risks and uncertainties. These statements include
Leap's expectations with respect to the development and advancement
of DKN-01, including the initiation, timing and design of future
studies, enrollment in future studies, potential for the receipt of
future option exercise, milestone, or royalty payments from
BeiGene, and other future expectations, plans and prospects.
Although Leap believes that the expectations reflected in such
forward-looking statements are reasonable as of the date made,
forward-looking statements are subject to known and unknown risks,
uncertainties and other factors that could cause actual results to
differ materially from our expectations. Such risks and
uncertainties include, but are not limited to: that the initiation,
conduct, and completion of clinical trials, laboratory operations,
manufacturing campaigns, and other studies may be delayed,
adversely affected, or impacted by COVID-19 related issues; the
accuracy of our estimates regarding expenses, future revenues,
capital requirements and needs for financing; the outcome, cost,
and timing of our product development activities and clinical
trials; the uncertain clinical development process, including the
risk that clinical trials may not have an effective design or
generate positive results; our ability to obtain and maintain
regulatory approval of our drug product candidates; the size and
growth potential of the markets for our drug product candidates;
our ability to continue obtaining and maintaining intellectual
property protection for our drug product candidates; and other
risks. Detailed information regarding factors that may cause actual
results to differ materially will be included in Leap Therapeutics'
periodic filings with the SEC, including Leap's Annual Report on
Form 10-K for the fiscal year ended December
31, 2020, as filed with the SEC on March 12, 2021 and as may be updated by Leap's
Quarterly Reports on Form 10-Q and the other reports Leap files
from time to time with the SEC. Any forward-looking statement
contained in this release speaks only as of its date. Leap
undertakes no obligation to update any forward-looking statement
contained in this release to reflect events or circumstances
occurring after its date or to reflect the occurrence of
unanticipated events.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Heather Savelle
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
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SOURCE Leap Therapeutics, Inc.