CAMBRIDGE, Mass., Sept. 30,
2024 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq:
LPTX), a biotechnology company focused on developing targeted and
immuno-oncology therapeutics, today announced that enrollment of
188 patients has been completed in the randomized controlled Part B
of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1
(DKK1) antibody, in combination with
standard of care bevacizumab and chemotherapy as a second-line
treatment for patients with advanced colorectal cancer (CRC).
"The completion of enrollment in Part B of the DeFianCe study
marks a significant achievement and highlights the enthusiasm in
the potential of DKN-01 from both patients and healthcare
providers," said Cynthia Sirard,
M.D., Chief Medical Officer of Leap. "The encouraging data from
Part A of the study which showed clinically meaningful response
rates and durable tumor reductions, as well as a favorable safety
profile in advanced CRC patients, provides a strong foundation
to the expanded Part B of the study. We look forward to sharing
initial data from Part B, including the subpopulation of patients
with left-sided CRC, in mid 2025."
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. Part B of
the study expanded from a 130 to a 188-patient randomized
controlled trial, with the primary endpoint being progression free
survival (PFS). An additional primary endpoint will measure PFS in
the subpopulation of patients with left-sided CRC. Secondary
objectives include objective 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. 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 the anticipated timing of the release of
clinical data, and any outcomes of such trials; the interpretation
or signficiance of, or any conclusions or suggestions that can
or should be drawn from, the results of, and the clinical data
generated from, any of our clinical trials; 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; the ability to enter into a
strategic partnership for DKN-01 or any of Leap's other 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, including that
subsequent or final results from Leap's clinical trials or
pre-clinical studies may supersede, qualify, limit, or change the
interpretation or significance of, preliminary or earlier results
of Leap's clinical trials or 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 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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