Leap Therapeutics, Inc. (Nasdaq:LPTX) has announced the completion of enrollment in the expanded randomized controlled Part B of the Phase 2 DeFianCe study. This study is evaluating DKN-01, Leap's anti-DKK1 monoclonal antibody, in combination with standard-of-care bevacizumab and chemotherapy in second-line patients with advanced colorectal cancer (CRC). Initial data from this part of the study are expected in mid-2025.
Patient follow-up is also continuing in the randomized controlled Part C of the Phase 2 DisTinGuish study. This trial is assessing DKN-01 in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer. The company anticipates sharing initial randomized controlled data from the DisTinGuish study in late 2024 or early 2025.
Advancing FL-501 Development
Leap Therapeutics has initiated the development of FL-501, its anti-GDF-15 monoclonal antibody. Preclinical data suggest that FL-501 could be a potential best-in-class antibody for neutralizing GDF-15 to treat patients with cachexia and other GDF-15-driven diseases. FL-501 is also being explored for its potential to enhance the activity of the immune system within the tumor microenvironment. Preclinical models of cachexia have shown that FL-501 increases body weight and restores muscle mass.
Clinical Trial Details
The DeFianCe study (NCT05480306) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with bevacizumab and chemotherapy for advanced CRC patients who have received one prior systemic therapy. Part B of the study enrolled 188 patients.
The DisTinGuish study (NCT0436380) is a Phase 2, randomized, controlled, open-label study of DKN-01 in combination with tislelizumab and chemotherapy in first-line, HER-2 negative patients with GEJ and gastric cancer. Part C of this study enrolled 170 patients.
Financial Position
Leap Therapeutics reported a net loss of $18.2 million for the third quarter of 2024, compared to a net loss of $13.7 million for the same period in 2023. Research and development expenses for the third quarter of 2024 were $14.9 million, compared to $11.5 million for the same period in 2023. As of September 30, 2024, Leap Therapeutics had cash and cash equivalents totaling $62.8 million, which is expected to fund operations into Q2 2026.
Executive Commentary
"We have made significant progress advancing our pipeline this quarter, including the completion of enrollment in the expanded Part B of the Phase 2 DeFianCe study of DKN-01 in patients with advanced colorectal cancer," said Douglas E. Onsi, President and Chief Executive Officer of Leap. "We look forward to sharing initial randomized controlled data from the DisTinGuish study and the DeFianCe study in the coming months. In addition, based on positive preclinical data, we are enthusiastically moving FL-501 into development. With a strong cash position that is expected to fund operations into Q2 2026, Leap is well positioned for continued success and long-term growth to deliver personalized medicines to patients fighting against cancer."
