Leap Therapeutics Announces Collaboration With EORTC to Evaluate DKN-01 in Combination with PD-L1 Cancer Immunotherapy and Ch...
September 08 2017 - 7:00AM
Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company
developing targeted and immuno-oncology therapeutics, today
announced an immunotherapy collaboration with the European
Organisation for Research and Treatment of Cancer (EORTC). The
cooperative group sponsored clinical trial will evaluate DKN-01 in
combination with atezolizumab (TECENTRIQ®) +/- paclitaxel in
advanced esophagogastric malignancies and DKN-01 + atezolizumab in
advanced biliary tract cancers at EORTC centers across Europe.
Roche will supply atezolizumab to the EORTC for this study
collaboration.
“DKN-01 has shown promising activity in advanced
esophagogastric and biliary tract cancers. Given the emerging role
of Wnt/beta-catenin in immuno-oncology, we believe that DKN-01
could be a novel immunotherapy for these patients and look forward
to evaluating its activity when combined with atezolizumab and
paclitaxel,” commented Markus Moehler, M.D., Ph.D, Professor of
Gastrointestinal (GI) Oncology, principal investigator of the study
and member of the GI group of the EORTC.
“We look forward to expanding our clinical studies
into Europe with the support of the EORTC Gastrointestinal tract
cancer Group (GITCG). This immunotherapy collaboration further
expands our vision as we look to build upon the foundational
activity we have seen with DKN-01 and backbone chemotherapy in
these malignancies with significant unmet medical need,” commented
Cynthia Sirard, M.D., Vice President, Clinical Development of Leap
Therapeutics.
The study is expected to begin enrolling patients
in 2018 and aims to understand the synergy between DKN-01, a
Wnt-targeted therapy, and an immune checkpoint inhibitor with and
without chemotherapy. The study will explore the efficacy and
safety of the combination as well as aim to identify
biomarkers.
About Leap TherapeuticsLeap
Therapeutics’ (NASDAQ:LPTX) most advanced clinical candidate,
DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1
(DKK1) protein. DKN-01 is in clinical trials in patients with
esophagogastric cancer, alone and in combination with paclitaxel,
and in patients with biliary tract cancer, in combination with
gemcitabine and cisplatin. An investigator-initiated study of
DKN-01 will be conducted in hepatocellular carcinoma patients, in
combination with sorafenib. DKN-01 has demonstrated single
agent activity in non-small cell lung cancer patients. Leap’s
second clinical candidate, TRX518, is a novel, humanized GITR
agonist monoclonal antibody designed to enhance the immune system’s
anti-tumor response that is in two monotherapy studies. For
more information about Leap Therapeutics, visit
http://www.leaptx.com or our public filings with the SEC that are
available via EDGAR at http://www.sec.gov or via
http://www.investors.leaptx.com/.
About EORTCThe European
Organisation for the Research and Treatment of Cancer (EORTC),
based in Brussels, Belgium, is a unique pan European clinical
research organization providing the infrastructure to conduct
international clinical cancer research. It brings together over
2500 multidisciplinary clinical cancer experts from more than 300
hospitals in over 30 countries, offering an integrated approach to
drug development, drug evaluation programmes and medical
activities.
TECENTRIQ® (atezolizumab) is a registered trademark
of Genentech, a member of the Roche Group.
FORWARD LOOKING STATEMENTS
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, which involve
risks and uncertainties. These statements include statements
relating to Leap’s expectations with respect to the development and
advancement of DKN-01, TRX518, and other programs, including Leap’s
belief that DKN-01 will be a novel therapy for patients with
advanced esophagogastric and biliary tract cancers, the initiation,
timing and design of future DKN-01 combination studies, the
expansion of studies into Europe, enrollment in future studies,
business development, and other future expectations, plans and
prospects. Leap has attempted to identify forward looking
statements by such terminology as ‘‘believes,’’ ‘‘estimates,’’
‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’
‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ or other words
that convey uncertainty of future events or outcomes to identify
these forward-looking statements. Although Leap believes that the
expectations reflected in such forward-looking statements are
reasonable as of the date made, forward-looking statements are
subject to risks and uncertainties that could cause actual results
to differ materially from our expectations. These risks and
uncertainties include, but are not limited to: the outcome, cost,
and timing of our product development activities and clinical
trials; the uncertain clinical development process, including the
risk that clinical trials may not have an effective design or
generate positive results; our ability to obtain and maintain
regulatory approval of our drug product candidates; our plans to
research, develop, and commercialize our drug product candidates;
our ability to achieve market acceptance of our drug product
candidates; unanticipated costs or delays in research, development,
and commercialization efforts; the applicability of clinical study
results to actual outcomes; the size and growth potential of the
markets for our drug product candidates; the accuracy of our
estimates regarding expenses, future revenues, capital requirements
and needs for financing; our ability to continue obtaining and
maintaining intellectual property protection for our drug product
candidates; and other risks. Detailed information regarding factors
that may cause actual results to differ materially will be included
in Leap Therapeutics’ periodic filings with the Securities and
Exchange Commission (the "SEC"), including Leap Therapeutics’
Form 10-K that Leap filed with the SEC on March 31, 2017. These
statements are only predictions and involve known and unknown
risks, uncertainties, and other factors. Any forward looking
statements contained in this release speak only as of its date. We
undertake no obligation to update any forward-looking statements
contained in this release to reflect events or circumstances
occurring after its date or to reflect the occurrence of
unanticipated events.
CONTACT:
Douglas E. Onsi
Chief Financial Officer
Leap Therapeutics, Inc.
donsi@leaptx.com
617-714-0360
Argot Partners
Susan Kim
212-203-4433
susan@argotpartners.com
or
Heather Savelle
617-663-4863
heather@argotpartners.com
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