CAMBRIDGE, Mass., July 12, 2023 /PRNewswire/ -- Leap Therapeutics,
Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that,
based on the early efficacy and momentum seen in the enrollment of
33 patients with colorectal cancer (CRC) in its DeFianCe study, it
has initiated the 130 patient randomized controlled Part B of the
Phase 2 study. The study evaluates Leap's anti-Dickkopf-1
(DKK1) antibody, DKN-01, in
combination with standard of care bevacizumab and chemotherapy
as a second-line treatment for patients with advanced CRC.
"Part A of the DeFianCe study enrolled an aggressive
heterogenous population of second-line CRC patients representative
of the second-line population that we see in the clinic who have
poor outcomes on standard of care drugs and are in need of new
therapies," said Zev Wainberg, MD,
Professor Medicine at UCLA and
co-director of the UCLA GI Oncology Program. "Exceeding a 20%
overall response rate with a high disease control rate in
second-line CRC patients is a clinically meaningful efficacy signal
and worthy of further exploration."
"The study enrolled quickly and has already exceeded the 20%
overall response rate threshold. After the planned safety review
meeting with our investigators, we decided to initiate the
randomized controlled study," said Cynthia
Sirard, MD, Chief Medical Officer of Leap. "We continue to
follow these Part A patients to assess durability of response,
progression-free survival, and to determine whether additional
patients with stable disease may become responders over time. We
very much look forward to presenting this maturing data set at an
upcoming meeting."
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. Leap expects to be able
to enroll Part B in approximately 12 months and have initial data
in late 2024.
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 outcomes of patients in Part A of the
DeFianCe study, the anticipated timing for initiation of or success
of enrollment in Part B of the DeFianCe study and other clinical
trials and 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; the continuation over time
of the clinical collaboration with BeiGene on the ongoing Part C of
the DisTinGuish trial, with BeiGene continuing to supply
tislelizumab; the ability of NovaRock Biotherapeutics to conduct
the FL-301 clinical trial in China; 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) 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, global conflict, or
supply chain related issues; and (vii) whether Leap's cash
resources will be sufficient to fund Leap's continuing operations
and planned studies. 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.