CAMBRIDGE, Mass. ,
Jan. 2,
2024 /PRNewswire/ -- Leap Therapeutics, Inc.
(Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that
enrollment has been completed in the randomized controlled Part C
of the DisTinGuish study evaluating DKN-01, Leap's anti-Dickkopf-1
(DKK1) antibody, in combination with
tislelizumab, BeiGene's anti-PD-1 antibody, and chemotherapy in
patients with advanced gastroesophageal junction and gastric
cancer.
"The completion of enrollment in Part C of the DisTinGuish study
is an important milestone and continues to underscore the high
level of interest from both patients and investigators in DKN-01,"
said Cynthia Sirard, M.D., Chief
Medical Officer of Leap. "Long-term follow-up data from Part A of
the study clearly demonstrated the potential to induce durable
responses and clinically meaningful survival outcomes in first-line
advanced gastroesophageal junction and gastric cancer patients. We
expect Part C to further validate the potential of DKN-01 and
tislelizumab combination therapy and look forward to having initial
data from Part C over the course of this year."
Part C of the DisTinGuish study (NCT0436380) is a Phase 2,
randomized, open-label, multicenter study of DKN-01 in combination
with tislelizumab and chemotherapy in first-line patients with
advanced gastroesophageal adenocarcinoma. Part C enrolled 170
first-line, HER2-negative patients. Patients were randomized 1:1 to
evaluate DKN-01 in combination with tislelizumab and standard of
care (SOC) chemotherapy, compared to tislelizumab and SOC
chemotherapy alone. The primary objective is progression-free
survival (PFS) in DKK1-high and in
all patients. Secondary objectives of Part C include overall
survival and objective response rate as measured by RECIST v1.1 in
DKK1-high and in all patients.
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 the anticipated timing release of clinical
data, and any outcomes of such 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 new
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; (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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SOURCE Leap Therapeutics, Inc.