Leap Therapeutics Announces Strong Topline DKN-01 Combo Study Data (MCUR)

October 10, 2016 7:14 AM EDT

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Leap Therapeutics, Inc. announced the presentation of top-line data from its clinical trial of DKN-01 combination therapy in patients with cholangiocarcinoma at the European Society for Medical Oncology 2016 Congress (ESMO 2016) in Copenhagen, Denmark. Lipika Goyal, MD, of Massachusetts General Hospital, an investigator on the study, presented a poster entitled “Phase I study of DKN-01, an anti-DKK1 monoclonal antibody, in combination with gemcitabine and cisplatin in patients with advanced biliary cancer.” DKN-01 is a humanized monoclonal antibody targeting Dickkopf-1 (DKK1), a secreted protein that modulates cell signaling of the Wnt pathways and that promotes an immunosuppressive tumor microenvironment. Published studies have indicated that DKK1 expression levels are elevated in patients with cholangiocarcinoma and associated with worse overall survival.

The two-part open-label, dose-escalating study enrolled 27 patients with cholangiocarcinoma who were treated with DKN-01 in combination with gemcitabine and cisplatin. In Part A, patients received DKN-01 at either 150 (n=4) or 300 mg (n=3) with 1000 mg/m2 of gemcitabine and 25 mg/m2 of cisplatin on days 1 and 8 of each 21-day cycle. The Part B expansion portion of the study evaluated the 300 mg dose of DKN-01 in combination with gemcitabine and cisplatin in 20 additional patients. The primary objective of this study was to evaluate the safety, pharmacokinetics, and efficacy of DKN-01 in combination with gemcitabine and cisplatin in treatment-naïve and previously-treated patients.

Data from the study showed that DKN-01 in combination with gemcitabine and cisplatin was well tolerated and safe at each dose level. There were no DKN-01 reported related serious adverse events or dose limiting toxicities. At the selected 300 mg 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 median progression-free survival and overall survival have not yet been reached, as many patients remain on study receiving therapy.

“Patients with advanced cholangiocarcinoma have no approved therapies beyond standard gemcitabine/cisplatin chemotherapy and desire better clinical outcomes. These early but promising results from the ongoing single arm study of DKN-01 in combination with gemcitabine and cisplatin demonstrate the potential of DKN-01 in aggressive cancers, such as cholangiocarcinoma, and provide a strong rationale for further clinical development,” commented Andrew Zhu, MD, of Massachusetts General Hospital, an investigator in the study and co-author on the poster.

About Cholangiocarcinoma

Cholangiocarcinoma is a cancer that starts in the bile duct, a thin tube about 4 to 5 inches long that reaches from the liver to the small intestine. The major function of the bile duct is to move a fluid called bile from the liver and gallbladder to the small intestine, where it helps digest the fats in food. The Cholangiocarcinoma Foundation estimates that approximately 6,000 patients will be diagnosed with cholangiocarcinoma in the United States each year, with publications estimating that nearly 200,000 patients are diagnosed worldwide each year. The majority of cholangiocarcinoma cases are diagnosed with advanced stage disease with a 5-year survival rate of less than 10%. The standard treatment option for advanced patients is systemic chemotherapy and supportive care.

About DKN-01

DKN-01 is a humanized IgG4 monoclonal antibody with neutralizing activity against the Dickkopf-1 (DKK1) protein. High levels of DKK1 expression has been associated with poor prognosis in multiple cancers, and DKK1 has a critical role in mediating Wnt signaling pathways and maintaining an immunosuppressive tumor microenvironment. DKN-01 is currently being studied in clinical trials in esophageal cancer and cholangiocarcinoma. DKN-01 additionally demonstrated single agent activity in NSCLC in a Phase 1 dose escalation study.

About Leap Therapeutics

Leap Therapeutics is an immuno-oncology company with two clinical stage programs. Leap’s 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 esophageal cancer in combination with paclitaxel and in patients with cholangiocarcinoma in combination with gemcitabine and cisplatin. Leap’s second clinical candidate, TRX518, is a novel, humanized GITR agonist monoclonal antibody designed to enhance the immune system’s anti-tumor response.

Leap has signed a Merger Agreement with Macrocure Ltd. (Nasdaq: MCUR) which is expected to result in Leap becoming a public company. For more information about Leap Therapeutics or the merger with Macrocure, visit http://www.leaptx.com or our public filings with the SEC that are available via EDGAR at http://www.sec.gov.

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