Leap Therapeutics Reports Updated Clinical Data from Sirexatamab Colorectal Cancer Study

Leap Therapeutics reported updated clinical data from its Sirexatamab Colorectal Cancer study, demonstrating statistically significant improvements in progression-free survival (PFS) in the DKK1-high, VEGF-naïve, and liver metastasis subgroups. The company's Board of Directors has initiated a process to explore strategic alternatives to maximize shareholder value.

Leap Therapeutics, Inc. (Nasdaq: LPTX), a biotechnology company focused on developing targeted and immuno-oncology therapeutics, has reported updated clinical data from its DeFianCe study, demonstrating statistically significant improvements in progression-free survival (PFS) in specific patient subgroups. The company's Board of Directors has initiated a process to explore strategic alternatives to maximize shareholder value.

The updated data from the DeFianCe study, which is a Phase 2 study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy alone, shows a positive trend on overall response rate (ORR) and PFS in the full second-line colorectal cancer (CRC) population. The study was conducted in patients with advanced microsatellite stable (MSS) CRC who had received one prior systemic therapy for advanced disease.

Key findings include:
- In patients with high levels of DKK1, no prior exposure to anti-VEGF therapy, or liver metastasis, sirexatamab demonstrated a statistically significant benefit in PFS and ORR.
- The median PFS in the sirexatamab arm was 9.2 months compared to 8.31 months in the control arm, with a hazard ratio (HR) of 0.84 (p = 0.1749).
- The ORR by investigator assessment (IA) was 35.1% in the sirexatamab arm compared to 26.6% in the control arm (p = 0.1009).

Given the current market conditions, Leap Therapeutics has decided to wind down the DeFianCe clinical trial and reduce internal expenses. The company will implement a workforce reduction of approximately 75% over the next two months, with total cash payments and costs related to this reduction estimated to be approximately $3.2 million.

The company has initiated a review of the full range of strategic alternatives to preserve and maximize shareholder value, including leveraging its cash balance and exploring potential sale or partnership opportunities for sirexatamab and FL-501. The Board of Directors has approved the engagement of Raymond James & Associates, Inc. to serve as exclusive financial advisor to assist in this strategic evaluation process.

References:
[1] https://www.prnewswire.com/news-releases/leap-therapeutics-reports-updated-clinical-data-from-sirexatamab-colorectal-cancer-study-and-announces-exploration-of-strategic-alternatives-302487496.html
[2] https://www.morningstar.com/news/pr-newswire/20250623ne15330/leap-therapeutics-reports-updated-clinical-data-from-sirexatamab-colorectal-cancer-study-and-announces-exploration-of-strategic-alternatives