Core Insights - Leap Therapeutics, Inc. announced the presentation of final clinical results from Part B of the DeFianCe study, focusing on the efficacy of sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy for advanced microsatellite stable colorectal cancer [1][2] Company Overview - Leap Therapeutics is a biotechnology company specializing in targeted and immuno-oncology therapeutics, with a pipeline that includes sirexatamab (DKN-01) and FL-501, both humanized monoclonal antibodies targeting specific proteins [2] Clinical Study Details - The DeFianCe study is a Phase 2 trial comparing the Sirexatamab Arm (sirexatamab plus bevacizumab and chemotherapy) to the Control Arm (bevacizumab and chemotherapy) in patients who have received one prior systemic therapy for advanced disease [1][2] - The final results will be presented at the European Society for Medical Oncology (ESMO) Congress 2025, scheduled for October 17-21 in Berlin, Germany [1]

Core Viewpoint - Leap Therapeutics is exploring strategic alternatives to maximize shareholder value following updated positive results from the DeFianCe study, which demonstrated significant benefits of sirexatamab in specific patient subgroups with advanced colorectal cancer [1][2][7]. Study Results - The DeFianCe study (NCT05480306) showed that sirexatamab, in combination with bevacizumab and chemotherapy, provided statistically significant improvements in progression-free survival (PFS) and overall response rate (ORR) among patients with high DKK1 levels, no prior anti-VEGF therapy, or liver metastasis [1][3]. - In the intent-to-treat population (n=188), the median PFS for the sirexatamab arm was 9.2 months compared to 8.31 months for the control arm, with a hazard ratio (HR) of 0.84 [3]. - For patients with high DKK1 levels (n=44), the median PFS was 9.36 months for the sirexatamab arm versus 5.88 months for the control arm, with a significant p-value of 0.0237 [4]. - In patients who had not received prior anti-VEGF therapy (n=95), the median PFS was 11.2 months for the sirexatamab arm compared to 8.34 months for the control arm, with a p-value of 0.0383 [5]. Corporate Actions - Due to current market conditions, Leap Therapeutics has decided to wind down the DeFianCe clinical trial and implement a workforce reduction of approximately 75%, with estimated costs of $3.2 million related to severance payments [2][6]. - The company has engaged Raymond James & Associates, Inc. as an exclusive financial advisor to assist in exploring strategic alternatives, including potential sales or partnerships for sirexatamab and FL-501 [7]. - As of March 31, 2025, Leap's cash and cash equivalents totaled $32.7 million, indicating a need for strategic financial management [6].

Core Viewpoint - Leap Therapeutics is hosting a virtual KOL event to discuss the potential of sirexatamab (DKN-01) in treating advanced microsatellite stable colorectal cancer, highlighting its clinical data and unmet medical needs [1][2][3] Company Overview - Leap Therapeutics, Inc. is a biotechnology company focused on developing targeted and immuno-oncology therapeutics, with its most advanced clinical candidate being sirexatamab, a humanized monoclonal antibody targeting the DKK1 protein [5] - The company is also developing FL-501, another humanized monoclonal antibody targeting GDF-15, which is currently in preclinical development [5] Event Details - The virtual KOL event will feature Dr. Zev A. Wainberg from UCLA, who will discuss the unmet needs in treating advanced MSS colorectal cancer and the potential improvements offered by sirexatamab [1][2] - The event will review positive data from Part B of the Phase 2 DeFianCe study, focusing on second-line patients with advanced MSS CRC [3] - A live Q&A session will follow the discussion, and a replay will be available on the company's investor page [3] Research and Development - Dr. Wainberg's research includes clinical trials for various gastrointestinal cancers, and he is currently focused on targeting cancer stem cells and molecular classification of gastrointestinal cancers [4] - Sirexatamab is being studied specifically for its efficacy in patients with colorectal cancer, addressing a significant unmet need in the treatment landscape [2][5]