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CAMBRIDGE, Mass. - Leap Therapeutics, Inc. (NASDAQ:LPTX), a clinical-stage biotech company with a market capitalization of $86 million and an overall "Fair" financial health rating according to InvestingPro, has announced positive initial data from its DeFianCe study for the treatment of advanced colorectal cancer (CRC), showing a higher objective response rate (ORR) with its drug sirexatamab when used in combination with bevacizumab and chemotherapy. The company also shared initial data from its DisTinGuish study in gastric cancer, which did not meet the necessary criteria to proceed to Phase 3.
The DeFianCe study, a Phase 2 trial involving 188 patients with advanced microsatellite stable CRC, demonstrated a 35% ORR in the experimental arm compared to a 23% ORR in the control arm. This improvement was observed across various subgroups, including patients with high levels of the protein DKK1, which is targeted by sirexatamab. The data suggest a correlation between DKK1 levels and clinical activity, indicating potential for a biomarker-driven approach to treatment.
In light of these findings, Leap Therapeutics is preparing for a registrational Phase 3 study in second-line CRC patients, focusing on those with high unmet needs and specific biomarker profiles. The company maintains a strong liquidity position with a current ratio of 3.97x and more cash than debt on its balance sheet, though InvestingPro data indicates rapid cash burn remains a concern. Subscribers can access 8 additional key financial insights about LPTX. The company has outlined potential populations for this study, including patients naive to anti-VEGF therapy, those who have experienced anti-EGFR therapy, and those with RAS wildtype tumors.
Conversely, the DisTinGuish study's Part C did not yield a clear positive signal in the primary progression-free survival endpoints for advanced gastroesophageal junction and gastric cancer. Despite showing activity in biomarker populations, the study's results led Leap to decide against advancing to Phase 3 in gastric cancer. Instead, the company will concentrate its efforts on CRC and seek strategic partnerships to further develop sirexatamab in other indications.
Leap plans to present more detailed clinical data in a conference call today at 8:00 a.m. Eastern Time. The call will discuss the implications of these studies and the company's strategy moving forward. The stock has experienced significant volatility, declining 8.5% in the past week, while analysts maintain a consensus buy rating with substantial upside potential. The next earnings report is scheduled for March 19, 2025, where investors will get more clarity on the company's financial trajectory.
The information in this article is based on a press release statement from Leap Therapeutics.
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