CAMBRIDGE, Mass., April 20, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology
company developing targeted and immuno-oncology therapeutics, today announced that interim data from the Phase 1 study of DKN-01 in
combination with standard of care chemotherapy in patients with advanced biliary tract cancers will be presented at the American
Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6, 2017 in Chicago, Illinois. The presentation is entitled, “A
phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in patients
(pts) for first-line therapy with advanced biliary tract cancer (BTC).” The data will be presented during the gastrointestinal
cancer poster session.
About the DKN-01 P103 Clinical Trial
The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received
two dose levels of DKN-01 in combination with gemcitabine and cisplatin. The primary objective of this study is to evaluate the
safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin. The study has recently been
expanded to enroll an additional 20 patients to enhance biomarker collection and analysis.
Leap Poster Presentation Details:
Abstract Number: 4075
Title: “A phase I study of DKN-01 (D), an anti-DKK1 monoclonal antibody, in combination with gemcitabine (G) and cisplatin (C) in
patients (pts) for first-line therapy with advanced biliary tract cancer (BTC).”
Session Title: Poster Session: Gastrointestinal (Noncolorectal) Cancer
Date: June 3, 2017
Time: 8:00AM-11:30AM Central Time
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 gastroesophageal cancer in combination with paclitaxel and
in patients with biliary tract cancers in combination with gemcitabine and cisplatin. 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. 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/.
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 the initiation, timing and design of future studies, 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
