Core Insights - Silexion Therapeutics is progressing towards initiating its Phase 2/3 clinical trial for SIL204, aimed at treating locally advanced pancreatic cancer, with plans to submit regulatory documents in Israel by the end of Q4 2025 and in Germany by Q1 2026 [1][2][3] Regulatory Developments - The company received formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM), which provides clarity on the proposed trial design, including clinical design, dosing plans, patient population strategy, and manufacturing considerations [1][2] - This positive feedback is seen as a significant milestone that supports the acceptability of the proposed study design based on safety data and manufacturing specifications [2] Company Strategy and Operations - Silexion is on track to initiate the Phase 2/3 clinical trial in the first half of 2026, pending regulatory clearance, and is focused on advancing operational activities necessary for trial launch, including manufacturing readiness and clinical site preparations [3] - The company aims to address critical unmet needs in KRAS-mutated cancers, which are prevalent in solid tumor cancers [4]
Silexion Therapeutics Receives Positive Feedback from German Health Authority on Design of Phase 2/3 Clinical Trial in Pancreatic Cancer