Silexion Therapeutics Announces Submission of Phase 2/3 Clinical Trial Application to Israel for SIL204 in Locally Advanced Pancreatic Cancer

Core Insights - Silexion Therapeutics has initiated a regulatory application in Israel for its Phase 2/3 clinical trial of SIL204 targeting locally advanced pancreatic cancer, marking a significant milestone in its clinical development program [1][2][4] - The application is supported by successful toxicology studies and positive feedback from German regulatory authorities, with plans for further regulatory filings in Germany and the EU in Q1 2026 [1][2][4] - The planned Phase 2/3 trial aims to evaluate SIL204's dual-route administration strategy, which combines intratumoral delivery and systemic administration [4] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on RNA-based therapies for oncology, particularly targeting cancers with mutated KRAS oncogenes [5] - The company previously conducted a Phase 2a clinical trial for its first-generation product, which showed a positive trend compared to chemotherapy alone [5] Clinical Development - The regulatory submission in Israel is in collaboration with Sheba Medical Center, a top-ranked hospital, where the Israeli portion of the trial will be conducted [3] - The company plans to expand its clinical development to U.S. sites following the completion of safety run-in studies in Israel and Germany [2]