Full Press Release Details
Leap Therapeutics Announces Completion of Enrollment
in Part B of the DeFianCe Study
of DKN-01 for the Treatment of Colorectal Cancer
MA - September 30, 2024 - Leap Therapeutics, Inc. (Nasdaq:LPTX), a biotechnology company focused on developing
targeted and immuno-oncology therapeutics, today announced that enrollment of 188 patients has been completed in the randomized controlled
Part B of the DeFianCe study evaluating DKN-01, Leap's anti-Dickkopf-1 (DKK1) antibody, in combination with standard of care bevacizumab
and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC).
completion of enrollment in Part B of the DeFianCe study marks a significant achievement and highlights the enthusiasm in the potential
of DKN-01 from both patients and healthcare providers," said Cynthia Sirard, M.D., Chief Medical Officer of Leap. "The encouraging
data from Part A of the study which showed clinically meaningful response rates and durable tumor reductions, as well as a favorable
safety profile in advanced CRC patients, provides a strong foundation to the expanded Part B of the study. We look forward
to sharing initial data from Part B, including the subpopulation of patients with left-sided CRC, in mid 2025."
DeFianCe study (NCT05480306) is a Phase 2, open-label, global study of DKN-01 in combination with standard of care bevacizumab
and chemotherapy in patients with advanced CRC who have received one prior systemic therapy for advanced disease. Part B of the
study expanded from a 130 to a 188-patient randomized controlled trial, with the primary endpoint being progression free survival (PFS).
An additional primary endpoint will measure PFS in the subpopulation of patients with left-sided CRC. Secondary objectives include objective
response rate, duration of response, and overall survival.
About Leap Therapeutics
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. DKN-01 is being developed in patients with esophagogastric,
gynecologic, and colorectal cancers. For more information about Leap Therapeutics, visit http://www.leaptx.com or
view our public filings with the SEC that are available via EDGAR at http://www.sec.gov or via https://investors.leaptx.com/.
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programs; the ability to enter into a strategic partnership for DKN-01 or any of Leap's other programs; and any assumptions underlying
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President & Chief Executive Officer
Leap Therapeutics, Inc.