CAMBRIDGE, Mass., Dec. 11,
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 data in second-line
patients with advanced colorectal cancer from the DeFianCe study, a
Phase 2 study evaluating DKN-01, Leap's anti-Dickkopf-1
(DKK1) antibody, in combination with
standard of care bevacizumab and chemotherapy at the upcoming 2024
American Society of Clinical Oncology (ASCO) Gastrointestinal
Cancers Symposium taking place in San Francisco, CA and virtually on
January 18-20, 2024.
Leap Presentation Details:
Title: DKN-01 plus bevacizumab and chemotherapy as
second-line (2L) investigational therapy in advanced microsatellite
stable (MSS) colorectal adenocarcinoma (CRC): DeFianCe trial
Presenter: Meredith Pelster,
MD, MSc | Sarah Cannon Research Institute, Tennessee Oncology
Session Type: Poster Discussion Session
Session Title: Cancers of the Colon, Rectum, and Anus
Date and Time: Saturday, January 20, 2024, at
6:30 a.m. ET
Abstract Number: 104
Poster Session: Poster Session C
About the DeFianCe Study
The DeFianCe study
(NCT05480306) is a Phase 2, open-label, global study of DKN-01 in
combination with standard of care bevacizumab and chemotherapy in
patients with advanced CRC who have received one prior systemic
therapy for advanced disease. The Part A cohort enrolled 33
patients, including significant numbers of patients who had early
progression on first-line therapy, previous exposure to
bevacizumab, tumors with Ras mutations, or liver metastases. The
study has expanded into a 130-patient Part B randomized controlled
trial. The primary objective of the study is progression free
survival. Secondary objectives include overall response rate,
duration of response, and overall survival.
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.
All statements, other than historical facts, including
statements regarding the anticipated timing for completion of or
success of enrollment in the DeFianCe study or any other clinical
trial, the release of clinical data, and any outcomes of such
trials; the potential, safety, efficacy, and regulatory and
clinical progress of Leap's product candidates, including DKN-01;
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; and (vi) that the initiation, conduct, and
completion of clinical trials, laboratory operations, manufacturing
campaigns, and other studies may be delayed, adversely affected, or
impacted by global conflict, or supply chain related issues. 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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