CAMBRIDGE, Mass., May 17, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc. (Nasdaq: LPTX ), a biotechnology company developing targeted and immuno-oncology therapeutics, today reported interim data from the Phase 1 study of DKN-01 in combination with standard of care chemotherapy in patients with advanced biliary tract cancers. Data from the study was published online as an abstract in advance of a poster presentation being held at the American Society of Clinical Oncology (ASCO) Annual Meeting held June 2 - 6, 2017 in Chicago, Illinois.
“These data combining DKN-01 with gemcitabine and cisplatin are highly encouraging and provide a strong rationale for advanced clinical development. Biliary tract cancer is an aggressive disease with a poor prognosis and for which there are limited treatment options. First-line chemotherapy studies have reported response rates of 20% to 25%, progression-free survival of 5.6 to eight months, and overall survival of 11 to 12 months,” commented Jennifer Eads, MD, of the University Hospitals Siedman Cancer Center at Case Western Reserve University and an investigator on the study.
Data from the study showed that DKN-01 in combination with gemcitabine and cisplatin was well tolerated with no new emerging safety trends. At the selected 300 mg DKN-01 dose level, seven of 22 patients (31.8%) experienced a partial response and 21 patients experienced a partial response or stable disease, representing a disease control rate of 95.5%. The preliminary median progression-free survival was 9.4 months, and the median overall survival was not yet reached. The median number of cycles of DKN-01 was eight (range of one to 17), and the median duration on study was 206 days. Eight patients were still on therapy as of the time of data cut-off.
“This study suggests that DKN-01 shows activity in combination with gemcitabine and cisplatin. Results so far look promising, and further evaluation of its additional benefit over standard of care chemotherapy in patients with biliary tract cancer is warranted,” commented Juan Valle MB ChB MSc FRCP, Professor of Medical Oncology in the University of Manchester (Institute of Cancer Studies) and primary investigator of the landmark Phase 3 ABC-02 study evaluating gemcitabine and cisplatin for the treatment of advanced biliary tract cancers.
“We are encouraged by the impressive durable responses in patients with advanced biliary tract cancer,” said Christopher K. Mirabelli, Ph.D., Chief Executive Officer of Leap Therapeutics. “We have recently expanded the study to enroll an additional 20 patients to further characterize the patients that respond to DKN-01 combination therapy. Based on the safety and efficacy profile seen to date, we are aggressively moving DKN-01 forward in biliary tract cancer, genetically-defined patient populations in gastric, liver, and uterine cancers, and soon in combination with checkpoint inhibitors.”
About the Study The open-label, dose-escalation study enrolled 27 patients with treatment-naïve advanced biliary tract cancer. Patients received one of two dose levels (150 mg or 300 mg) of DKN-01 in combination with gemcitabine and cisplatin during Part A, with 20 additional patients treated at 300 mg dose level of DKN-01 in the Part B expansion cohort. The primary objective of this study is to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin.
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, 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/ .
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
