SLXNW · Silexion Therapeutics Ltd.

Silexion Therapeutics has achieved a key regulatory milestone by successfully submitting a Clinical Trial Application (CTA) for its lead siRNA candidate SIL204 to Germany's Federal Institute for Drugs and Medical Devices (BfArM) through the EU Clinical Trials Information System (CTIS). Germany serves as the Reporting Member State, leading the scientific assessment for the broader EU program. This submission builds on positive Scientific Advice from BfArM in December 2025 and includes comprehensive data from completed two-species toxicology studies confirming no systemic organ toxicity, alongside extensive preclinical evidence. It follows recent approval from the Israeli Ministry of Health, enabling parallel trial execution at leading oncology centers in Germany, other EU states, and Israeli sites led by Sheba Medical Center. The Phase 2/3 trial, structured with a safety run-in followed by randomization, will assess SIL204 combined with standard-of-care chemotherapy via an innovative dual-route strategy—intratumoral for primary tumors and systemic for metastases—in patients with locally advanced pancreatic cancer (LAPC), where KRAS mutations drive over 90% of cases. CEO Ilan Hadar emphasized this as a defining step extending SIL204's development into Europe under one of the world's most rigorous regulatory environments, aligning with the company's 2026 roadmap for Q2 trial initiation. This advances Silexion's RNAi platform targeting KRAS-driven solid tumors, addressing a critical unmet need in oncology.