On May 13, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported 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.
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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.
"Initiating GMP clinical supply manufacturing for SIL204 is a defining operational milestone that brings us materially closer to first patient dosing," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "With our drug product formulation now in production with Catalent under full GMP controls at its European center of excellence, we are translating years of preclinical science into regulator-ready clinical supply. This milestone reflects the strength of our CMC execution, much as our recent regulatory approval and submission in Israel and Germany, respectively, exhibit our strong progress on the regulatory front."
Silexion’s manufacturing relationship with Catalent at its Limoges, France, site; originally announced in April 2025, was established to optimize both the systemic and intratumoral delivery formulations of SIL204 in support of the Company’s dual-route administration strategy. The collaboration leverages Catalent’s extensive experience in complex injectable formulations and sustained-release technologies to enhance SIL204’s stability, bioavailability, and delivery precision.
The GMP clinical batches are being manufactured in accordance with validated production processes, controlled raw material sourcing, comprehensive in-process controls, and full quality testing and documentation, in preparation for final batch release and clinical use. Stability programs consistent with applicable regulatory guidelines have been initiated to support the clinical use of the material.
SIL204 is a next-generation siRNA therapy designed to silence mutated KRAS oncogenes, the most common oncogenic driver in human cancers, before cancer-driving proteins are expressed. The upcoming Phase 2/3 trial in LAPC will evaluate SIL204 in combination with standard-of-care chemotherapy, using the Company’s innovative dual-route administration strategy that combines intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The trial is structured as a safety run-in followed by a randomized cohort.
(Press release, Silexion Therapeutics, MAY 13, 2026, View Source [SID1234665660])