Silexion Therapeutics Corp. received approval from the Israeli Ministry of Health to initiate a Phase 2/3 clinical trial of SIL204 for locally advanced pancreatic cancer. This regulatory milestone advances SIL204 into clinical-stage development as a next-generation RNAi therapy targeting KRAS mutations present in over 90% of pancreatic cancers.
Key takeaways
Israeli Ministry of Health approval received on March 24, 2026, for Phase 2/3 trial of SIL204
Trial targets locally advanced pancreatic cancer with KRAS mutations in over 90% of cases
Positive preclinical results showed significant anti-tumor activity in multiple models
Successful completion of toxicology studies
Expects to initiate trial in second quarter of 2026
Plans to submit Phase 2/3 application in Germany by end of current quarter