CAMBRIDGE, Mass., April 26,
2023 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:
LPTX), a biotechnology company focused on developing targeted
and immuno-oncology therapeutics, today announced that the Company
will be presenting new long-term follow-up data in first-line
patients with advanced gastroesophageal adenocarcinoma (GEA) from
Part A of the DisTinGuish study, a Phase 2 clinical trial
evaluating Leap's anti-Dickkopf-1 (DKK1) antibody, DKN-01, in combination with
tislelizumab and chemotherapy, at the upcoming 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting taking place in
Chicago, IL on June 2-6, 2023.
Leap Presentation Details:
Title: A phase 2 study (DisTinGuish) of DKN-01 in
combination with tislelizumab + chemotherapy as first-line (1L)
therapy in patients with advanced gastric or GEJ adenocarcinoma
(GEA).
Presenter: Samuel J.
Klempner, Harvard Medical
School
Session Type: Poster Discussion Session
Session Title: Gastrointestinal Cancer—Gastroesophageal,
Pancreatic, and Hepatobiliary
Date and Time: Monday, June 5,
2023, at 11:30 a.m. ET
Abstract Number: 4027
Poster Number: 335
About the DisTinGuish Study
The DisTinGuish study
(NCT04363801) is a Phase 2 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 three parts in the United
States, the Republic of Korea, the United Kingdom, and Germany. Part A enrolled 25 first-line HER2-
GEA cancer patients to receive DKN-01 in combination with
tislelizumab and capecitabine and oxaliplatin. Part B enrolled 52
second-line GEA cancer patients whose tumors expressed high levels
of DKK1 to receive DKN-01 in
combination with tislelizumab. Part C is enrolling approximately
160 first-line HER2- GEA cancer patients in a randomized controlled
trial of DKN-01 in combination with tislelizumab and chemotherapy
compared to tislelizumab and chemotherapy.
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 being developed in
patients with esophagogastric, gynecologic, and colorectal cancers.
FL-301, is a humanized monoclonal antibody targeting Claudin18.2,
being developed in patients with gastric and pancreatic cancer.
Leap also has preclinical antibody programs targeting
Claudin18.2/CD137 and GDF15. 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/.
FORWARD-LOOKING STATEMENTS
This press release contains
forward-looking statements within the meaning of the federal
securities laws. Such statements are based upon current plans,
estimates and expectations of the management of Leap that are
subject to various risks and uncertainties that could cause actual
results to differ materially from such statements. The inclusion of
forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as "anticipate," "expect," "project,"
"intend," "believe," "may," "will," "should," "plan," "could,"
"continue," "target," "contemplate," "estimate," "forecast,"
"guidance," "predict," "possible," "potential," "pursue," "likely,"
and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify
forward-looking statements.
All statements, other than historical facts, including
statements regarding Part A of the DeFianCe trial; the anticipated
timing for the release of clinical data, and any outcomes of such
trial; the potential, safety, efficacy, and regulatory and clinical
progress of Leap's product candidates; our future preclinical and
clinical development plans in connection with our programs; and any
assumptions underlying any of the foregoing, are forward-looking
statements. Important factors that could cause actual results to
differ materially from Leap's plans, estimates or expectations
could include, but are not limited to: (i) Leap's ability to
successfully execute its clinical trials and the timing of
enrollment in and cost of such clinical trials; (ii) the results of
Leap's clinical trials and pre-clinical studies; (iii) Leap's
ability to successfully enter into new strategic partnerships for
DKN-01 or any of its other programs; (iv) whether any Leap clinical
trials and products will receive approval from the U.S. Food and
Drug Administration or equivalent foreign regulatory agencies; (v)
exposure to inflation, currency rate and interest rate
fluctuations, as well as fluctuations in the market price of Leap's
traded securities; (vi) whether the initiation, conduct, and
completion of clinical trials, laboratory operations, manufacturing
campaigns, and other studies may be delayed, adversely affected, or
impacted by ongoing COVID-19 related issues, global conflict or
supply chain related issues; (vii) whether Leap's stockholders
approve the conversion of the Series X Non-Voting Convertible
Preferred Stock; (viii) whether Leap's cash resources will be
sufficient to fund Leap's continuing operations; and (ix) Leap's
ability to comply with the continued listing requirements of the
Nasdaq Global Market. New risks and uncertainties may emerge from
time to time, and it is not possible to predict all risks and
uncertainties. No representations or warranties (expressed or
Implied) are made about the accuracy of any such forward-looking
statements. Leap may not actually achieve the forecasts disclosed
in such forward-looking statements, and you should not place undue
reliance on such forward-looking statements. Such forward-looking
statements are subject to a number of material risks and
uncertainties including but not limited to those set forth under
the caption "Risk Factors" in Leap's most recent Annual Report on
Form 10-K filed with the SEC, as well as discussions of potential
risks, uncertainties, and other important factors in its subsequent
filings with the SEC. Any forward-looking statement speaks only as
of the date on which it was made. Neither Leap, nor any of its
affiliates, advisors or representatives, undertake any obligation
to publicly update or revise any forward-looking statement, whether
as result of new information, future events or otherwise, except as
required by law. These forward-looking statements should not be
relied upon as representing Leap's views as of any date subsequent
to the date hereof.
CONTACT:
Douglas E. Onsi
President & Chief Executive Officer
Leap Therapeutics, Inc.
617-714-0360
donsi@leaptx.com
Matthew DeYoung
Investor Relations
Argot Partners
212-600-1902
leap@argotpartners.com
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