Leap Therapeutics Presents Positive DKN-01 Clinical Data in Biliary Tract Cancers at American Society of Clinical Oncology (ASCO) 2017 Annual Meeting

CAMBRIDGE, MA, USA I May 17, 2017 I 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/.

SOURCE: Leap Therapeutics

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