Leap Therapeutics to Present Data from Study Evaluating DKN-01 in Combination with KEYTRUDA® (pembrolizumab) at the European Society of Medical Oncology 2018 Congress
CAMBRIDGE, Mass., Oct. 8, 2018 /PRNewswire/ -- Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, today announced that data from the study of DKN-01 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced gastroesophageal cancer will be presented in a poster presentation at the European Society of Medical Oncology (ESMO) 2018 Annual Congress, taking place October 19-23, 2018 in Munich, Germany. The abstract was published online in advance of the poster presentation that will include additional patient data as the study has progressed since abstract submission.
About the DKN-01 P102 clinical trial:
The P102 esophagogastric cancer study is a multipart study evaluating DKN-01 as a monotherapy and in combination with paclitaxel or pembrolizumab in patients with advanced relapsed or refractory esophagogastric cancer. The arm evaluating DKN-01 with pembrolizumab includes both dose escalation and dose confirmation cohorts and is designed to evaluate the safety, pharmacokinetics and efficacy of the combination. Patients will receive DKN-01 (150 mg or 300 mg on Days 1 & 15) plus pembrolizumab (200 mg on Day 1) of each 21-day cycle. The dose expansion cohort (n=55) includes patients that are naïve (n=40) or refractory (n=15) to PD-1/PD-L1 antagonists.
Leap Poster Presentation Details
Presentation Number: 660P
Title: Safety and Efficacy of a DKK1 Inhibitor (DKN-01) in Combination with Pembrolizumab (P) in Patients (Pts) with Advanced Gastroesophageal (GE) Malignancies
Session Title: Gastrointestinal tumours – colorectal & non-colorectal
Date: October 21, 2018
Time: 12:45pm – 1:45pm CEST
Location: Hall A3 - Poster Area Networking Hub, ICM München
About Leap Therapeutics
Leap Therapeutics (NASDAQ:LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein, a Wnt pathway modulator. DKN-01 is in clinical trials in patients with esophagogastric cancer, biliary tract cancer, and gynecologic cancers, with an emerging focus on patients with defined mutations of the Wnt pathway and in combination with immune checkpoint inhibitors. Leap's second clinical candidate, TRX518, is a humanized GITR agonist monoclonal antibody designed to enhance the immune system's anti-tumor response that is in two advanced solid tumor 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.
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