Silexion advances toward Phase 2/3 trial in KRAS-driven pancreatic cancer, as SIL204 begins GMP clinical manufacturing in collaboration with global leading manufacturing partner Catalent at its European center of excellence

Tel Aviv Sourasky Medical Center's Helsinki Ethics Committee approves planned Phase 2/3 trial of SIL204 in locally advanced pancreatic cancer, marking an important clinical site activation milestone at a leading Israeli oncology center; Underscores continued regulatory momentum in preparation for trial initiation

Grand Cayman, Cayman Islands, May 13, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ:SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced the initiation of Good Manufacturing Practice (GMP) clinical batch manufacturing of SIL204, the Company's next-generation siRNA therapy targeting mutated KRAS, in support of the planned upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC). Additionally, the Company was pleased to announce that it has received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 trial of SIL204 at its site, a leading Israeli oncology center.

The clinical batches currently in production will serve as the Investigational Medicinal Product (IMP) supply used to treat the first patients to be enrolled in the safety run-in segment of the Phase 2/3 trial. The drug substance (active pharmaceutical ingredient) for SIL204 was successfully manufactured in 2025 by a specialist global oligonucleotide contract development and manufacturing organization, enabling seamless progression into drug product manufacturing. The drug product, the finished clinical formulation administered to patients, is now being manufactured by Catalent, Inc., a leading global CDMO championing the missions that help people live better and healthier lives, at its state-of-the-art facility in Limoges, France, Catalent's European center of excellence for clinical biologics formulation development and drug product manufacturing. The Limoges facility specializes in complex injectable formulations, and all activities are conducted in full compliance with applicable GMP standards.

This manufacturing milestone represents a key step in Silexion's CMC (Chemistry, Manufacturing, and Controls) readiness ahead of the planned Phase 2/3 trial and materially advances the Company's preparedness for first patient dosing. With the Israeli Ministry of Health's recent approval of the Phase 2/3 trial and the Company's Clinical Trial Application (CTA) submitted to Germany, Silexion is continuing to advance the operational steps to bring SIL204 into human trials. The Sourasky Medical Center Helsinki Ethics Committee approval, issued by one of Israel's leading academic medical centers, reflects on the solid scientific basis attributed to the Company's SIL 204 product candidate, and builds upon the foregoing Israeli Ministry of Health authorization and ongoing CTA review in Germany, reflecting multi-front regulatory progress towards the Company's planned Phase 2/3 clinical trial.