Leap Therapeutics' Strategic Shift Following Promising Sirexatamab Oncology Data Reveal

Leap Therapeutics' Update on Sirexatamab in Colorectal Cancer



Leap Therapeutics, a biotechnology company specializing in targeted and immuno-oncology therapeutics, has recently shared promising clinical data from its ongoing trials of Sirexatamab (DKN-01) for advanced colorectal cancer. As part of the DeFianCe study, the company highlighted improvements in progression-free survival (PFS) for specific patient subgroups, demonstrating the potential impact of Sirexatamab in treating this challenging disease.

Overview of the DeFianCe Study



The DeFianCe study is a Phase 2 clinical trial designed to assess the effectiveness of Sirexatamab in combination with bevacizumab and chemotherapy. This combination was compared with a control group receiving only the latter two treatments. The most notable findings indicate significant benefits in patients with elevated levels of Dickkopf-1 (DKK1) protein, who have not previously undergone anti-VEGF therapy or those with liver metastasis.

Key Findings:


  • - Overall response rate (ORR): The latest analysis revealed positive trends in the overall response rates, with the Sirexatamab arm achieving 35.1% based on investigator assessments compared to 26.6% in the control group. This was even more pronounced with blinded independent central review assessments showing an ORR of 33.0% versus 20.2% for the control.
  • - PFS for specific cohorts: Particularly impressive results were noted among patients with high DKK1 levels, showcasing a median PFS of 9.36 months for the Sirexatamab group compared to just 5.88 months in the control arm, marking a significant advancement.
  • - Statistical Significance: The results for PFS in certain subsets like those with no prior anti-VEGF exposure demonstrated a hazard ratio of 0.61, suggesting nearly a 40% reduction in the risk of disease progression compared to the control.

Corporate Strategy Moving Forward



Despite these promising findings, Leap Therapeutics has acknowledged ongoing challenges related to its financial situation. To navigate these hurdles, the board has decided to initiate a strategic review aimed at maximizing shareholder value through potential sales or partnerships related to Sirexatamab and their other pipeline candidate, FL-501.

Changes in Workforce and Operations


Employing a proactive approach to conserve capital, Leap Therapeutics is implementing a workforce reduction of approximately 75%, a decision that underlines the urgency of their financial strategy. The move is expected to incur around $3.2 million in total costs, primarily impacting their upcoming fiscal quarters.

Douglas E. Onsi, the company's President and CEO, expressed gratitude towards the patients and physicians involved in clinical trials for their continued dedication, emphasizing that despite winding down the DeFianCe study due to funding constraints, the gathered data supports the significant impact of Sirexatamab.

Conclusion



Leap Therapeutics is at a pivotal junction, with groundbreaking data from the DeFianCe study that may lead to advancements in colorectal cancer treatment through Sirexatamab. However, the company is also taking necessary steps to ensure sustainability and increase shareholder confidence amid shifting market dynamics. As they explore strategic alternatives, the potential for Sirexatamab remains promising in the fight against colorectal cancer, marking Leap Therapeutics as a company to watch in the coming months.

For ongoing updates about Leap Therapeutics and their innovative drug developments, visit Leap’s official website and keep an eye on future publications detailing their progress in the medical field.

Topics Health)

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