Leap Therapeutics Presents Positive Data from Clinical Study of
DKN-01 in Combination with Paclitaxel in Esophageal Cancer
Cambridge, MA – June 30TH, 2016 – Leap Therapeutics, an immuno-oncology company, reported updated results from a clinical trial of its lead candidate DKN-01, a monoclonal antibody against the Dickkopf-1 (DKK1) protein. Data from the trial demonstrated clinical activity in patients with relapsed or refractory cancer of the esophagus or gastroesophageal junction (GEJ), indications with few or no approved therapies.
In Study Parts A and B, the dose escalation and dose confirmation phases, eight of 22 patients achieved a partial response (“PR”) per RECIST v1.1. Preliminary data indicated an overall progression-free survival (“PFS”) of 3.9 months, and 6.2 months and 3.2 months for patients with adenocarcinoma (AC) and squamous cell carcinoma (ESCC), respectively. DKN-01 was generally well tolerated. The data were presented today by Deva Mahalingam, M.D., of the University of Texas Health Science Center and an investigator on the trial, at the European Society for Medical Oncology’s World Congress on Gastrointestinal Cancer in Barcelona.
“Relapsed or refractory esophageal carcinomas are typically highly invasive and have a poor prognosis. The clinical activity we have seen to-date has been promising and is greater than expected compared to historical controls,” commented Dr. Mahalingam.
“The results from the study of DKN-01 in combination with paclitaxel are promising. We look forward to the data from the next phases of this trial and further interrogating the activity of DKN-01 in additional trials going forward,” commented David Ryan, M.D. of Massachusetts General Hospital and an investigator on the trial.
Results from Part A and Part B of the P102 Study of DKN-01 in Esophageal Carcinoma:
Twenty-seven patients with cancer of the esophagus or GEJ were enrolled in Parts A and B; 22 were evaluable per the protocol at the date of this analysis
The combination of DKN-01 and paclitaxel was safe and well tolerated at all doses with no treatment related severe adverse events (SAEs) related to either DKN-01 or paclitaxel
The most frequently reported DKN-01-related AEs were fatigue, diarrhea, and decreased appetite
Eight patients (36.4%) had PRs and nine (40.9%) patients had best responses of Stable Disease, with a total disease control rate of 77%
Durable responses with patients remaining on therapy for 12+ months
Two long-term patients (one AC, one ESCC) with PRs continue on DKN-01 monotherapy with continued deepening of response as a single agent
Preliminary overall PFS for patients with adenocarcinoma of the esophagus or GEJ of 6.2 months and patients with squamous cell carcinoma of 3.2 months
About Esophageal Cancer
Esophageal cancer is an aggressive disease with 17,000 patients diagnosed annually in the US and 400,000 diagnosed worldwide. Over 50% of patients are diagnosed with advanced disease, with an expected overall survival limited to 8-12 months. There are no approved therapies for relapsed or refractory disease of the esophagus, with the majority of patients receiving single-agent paclitaxel as a 2ND-line therapy. While studies of efficacy are limited, response rates have historically ranged between 5-15% and progression-free survival of 1-3 months.
DKN-01 is a humanized IgG4 monoclonal antibody with neutralizing activity against the Dickkopf-1 (DKK1) protein. DKK1 expression in cancer tissue has been associated with poor prognosis in multiple cancers, and recent literature suggests DKK1 has a critical role in mediating an immuno-suppressive 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 that was presented at ASCO 2014.?
About Leap Therapeutics
Leap Therapeutics’ 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 in combination with paclitaxel and in patients with biliary tract cancers 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) that is expected to result in Leap becoming a public company that will trade on The Nasdaq Global Market under the symbol “LPTX.” 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.
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Leap Therapeutics, Inc.:
Douglas E. Onsi
Chief Financial Officer