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Silexion Therapeutics Receives Approval from Israeli Ministry of Health to Initiate Phase 2/3 Clinical Trial of SIL204 in Locally Advanced Pancreatic Cancer

  • Silexion Therapeutics Corp. received formal approval from the Israeli Ministry of Health to initiate a Phase 2/3 clinical trial for its RNAi therapy SIL204 targeting locally advanced pancreatic cancer.
  • The approval follows strong positive preclinical results demonstrating significant anti-tumor activity across multiple models & the successful completion of toxicology studies.
  • SIL204 is designed to silence KRAS mutations present in over 90% of pancreatic cancers using an integrated systemic delivery approach applicable to a broad range of KRAS variants.
  • The company expects to initiate human clinical trials in the second quarter of 2026, subject to site activation & standard clinical readiness procedures.
  • Silexion plans to submit a Phase 2/3 clinical trial application in Germany by the end of the current quarter, with additional European Union filings scheduled for early 2027.
  • The company intends to advance SIL204 into additional KRAS-driven indications, including colorectal & lung cancers.
  • Silexion is transitioning into a clinical-stage biotechnology company focused on KRAS-driven cancers, building on safety data from its predecessor product, Loder.