"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/.
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.
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