CAMBRIDGE, Mass., Sept. 08, 2017 (GLOBE NEWSWIRE) -- 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 Therapeutics
Leap 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 EORTC
The 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