Leap Therapeutics Presents Biomarker and Efficacy Data at the Cholangiocarcinoma Foundation 2017 Annual Meeting
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) 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, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer, biliary tract cancer, and gynecologic cancers, with an emerging focus on patients with defined mutations of the Wnt pathway and in combination with immune checkpoint inhibitors. Leap's second clinical candidate, TRX518, is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in two advanced solid tumor 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.
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 accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; the ability to complete a financing or form business development relationships to fund our expenses; 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; 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 February 23, 2018. 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. OPDIVO® is a registered trademark of Bristol-Myers Squibb Company. BAVENCIO® is a registered trademark of Pfizer, Inc.
Leap Therapeutics, Inc.:
Douglas E. Onsi
Chief Financial Officer