Leap Therapeutics Presents Biomarker and Efficacy Data at the Cholangiocarcinoma Foundation 2017 Annual Meeting
CAMBRIDGE, Mass., Jan. 23, 2017 (GLOBE NEWSWIRE) -- Leap Therapeutics, Inc.(Nasdaq:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced the completion of its merger with Macrocure Ltd(Nasdaq:MCUR), with Macrocure becoming a wholly-owned subsidiary of Leap. Leap will be listed on The Nasdaq Global Market under the symbol “LPTX” and expects to begin trading on Tuesday, January 24, 2017.
“Leap Therapeutics has achieved a milestone in our growth by becoming a public company,” commented Christopher K. Mirabelli, Ph.D., Chairman and Chief Executive Officer. “We are now well positioned to advance the development of our two clinical-stage monoclonal antibodies. We expect that Leap’s novel assets will create significant value for shareholders as the programs progress.”
Leap Therapeutics is conducting clinical studies with two best-in-class therapeutics.
DKN-01 is a humanized monoclonal antibody that binds to and blocks the action of the Dickkopf-1 (DKK1) protein, a modulator of Wnt/Beta-catenin signaling. DKK1 expression has been associated with poor prognosis in multiple cancers. Recent literature suggests DKK1has an important role in tumor cell signaling and in mediating an immuno-suppressive tumor microenvironment. DKN-01 is being studied in clinical trials in patients with esophageal, gastric, and biliary tract cancers. DKN-01 has demonstrated single agent activity in non-small cell lung cancer patients.
TRX518 is a humanized monoclonal antibody with agonist activity targeting glucocorticord-inducible TNF-superfamily receptor (GITR). TRX518 is engineered to enhance immune responses to cancer. In clinical studies, a single-dose of TRX518 is associated with a reduction in immunosuppressive cells known as T regulatory cells. TRX518 is being studied in two ongoing repeat-dose clinical trials in patients with advanced solid tumor malignancies.
Recent and Upcoming Clinical Data Presentations
Society for Immunotherapy in Cancer, November 2016, Oral presentation of TRX518 biomarker clinical data.
American Society for Clinical Oncology Gastrointestinal Symposium, January 2017, Poster presentation of DKN-01 biomarker and clinical data in gastroesophageal cancers.
Cholangiocarcinoma Foundation Annual Conference, February 2017, Presentation of DKN-01 biomarker and clinical data in biliary tract cancer.
Christopher K. Mirabelli, Ph.D., Chairman of the Board and Chief Executive Officer
Augustine Lawlor, Chief Operating Officer
Douglas E. Onsi, Chief Financial Officer
Dr. Mirabelli, Mr. Lawlor, and Mr. Onsi have worked together for over 20 years and developed dozens of biotechnology companies, public and private, including Adheron Therapeutics (acquired by Roche), Aton Pharmaceuticals (acquired by Merck), FoldRx (acquired by Pfizer), LeukoSite (acquired by Millennium Pharmaceuticals), Proteostasis Therapeutics, and Tensha Therapeutics (acquired by Roche). Notable drug approvals from these companies include Campath, Lemtrada, Entyvio, Velcade, Vyndaqel, and Zolinza.
In connection with the closing of the merger, HealthCare Ventures invested $10 million into Leap Therapeutics at a price of $9.90 per share. Following the merger, Leap will have 9,392,868 shares of common stock outstanding.
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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. OPDIVO® is a registered trademark of Bristol-Myers Squibb Company. BAVENCIO® is a registered trademark of Pfizer, Inc.
Leap Therapeutics, Inc.:
Douglas E. Onsi
Chief Financial Officer