Leap Therapeutics Presents Biomarker and Efficacy

CAMBRIDGE, Mass., Feb. 03, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq: LPTX ), a biotechnology company developing targeted and immuno-oncology therapeutics, announced the presentation of biomarker and top-line preliminary efficacy data from its clinical trial of DKN-01 combination therapy in patients with biliary tract cancers at the Cholangiocarcinoma Foundation 2017 Annual Meeting in Salt Lake City, UT.

Data from the study showed that Leap’s DKN-01 monoclonal antibody, an inhibitor of Dickkopf-1 (DKK1), in combination with gemcitabine and cisplatin resulted in statistically significant changes in inflammatory and anti-angiogenic biomarkers consistent with the anticipated mechanism of action of DKK1 inhibition. DKK1 is a regulator of Wnt/β-catenin signaling that can enable cancer to evade the immune system by enhancing the suppressive effects of myeloid-derived suppressor cells (MDSC) and reducing the expression of natural killer cell ligands. Additionally, DKK1 enables tumors to grow, metastasize, and promote blood vessel formation. DKN-01 is designed to help treat cancer patients by modulating Wnt/β-catenin signaling on tumor cells and MDSC to enhance immune targeting of cancer tumors and to decrease tumor cell growth and angiogenesis.

In the study to date, at the selected 300mg DKN-01 dose level, 7 of 21 evaluable patients (33%) experienced a partial response and 20 patients experienced a partial response or stable disease, representing a disease control rate of 95%. The study has recently been expanded to enroll an additional 20 patients to confirm the activity of the combination and to enhance biomarker collection and analysis. The biomarker data were reported yesterday evening by Dan G. Duda, DMD, PhD, Director of Translational Research in Gastrointestinal Radiation Oncology at Massachusetts General Hospital.

“These early data tie the promising clinical activity of DKN-01 combination therapy in patients with biliary tract cancer to pharmacodynamic biomarkers suggestive of promoting anti-tumor immunity and reducing angiogenesis. We are very encouraged by the data and look forward to expanding the study and further evaluating the biomarker activity of DKN-01 in patients with these cancers,” commented Dr. Duda.

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

Some of the statements in this release are 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 relate to future events of Leap’s development of DKN-01, TRX518, and other programs, future expectations, plans and prospects. Although Leap believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Leap has attempted to identify forward looking statements by terminology including ‘‘believes,’’ ‘‘estimates,’’ ‘‘anticipates,’’ ‘‘expects,’’ ‘‘plans,’’ ‘‘projects,’’ ‘‘intends,’’ ‘‘potential,’’ ‘‘may,’’ ‘‘could,’’ ‘‘might,’’ ‘‘will,’’ ‘‘should,’’ ‘‘approximately’’ or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. 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 Chris Erdman MacDougall Biomedical Communications cerdman@macbiocom.com 781-235-3060