SLXNW · Silexion Therapeutics Ltd.

Silexion Therapeutics announced two significant operational milestones: the initiation of GMP clinical supply manufacturing of its next-generation siRNA therapy SIL204 with leading global CDMO Catalent, and the approval of its planned Phase 2/3 trial by the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center. The GMP manufacturing is taking place at Catalent's European center of excellence in Limoges, France, which specializes in complex injectable formulations. The drug substance was successfully manufactured in 2025 by a specialist oligonucleotide CDMO, enabling seamless progression into drug product manufacturing. The clinical batches will serve as the Investigational Medicinal Product for the safety run-in segment of the Phase 2/3 trial in locally advanced pancreatic cancer (LAPC). The trial will evaluate SIL204 in combination with standard-of-care chemotherapy using a dual-route administration strategy (intratumoral and systemic). These milestones build upon the Israeli Ministry of Health's recent approval of the Phase 2/3 trial and the Company's Clinical Trial Application submitted to Germany, reflecting multi-front regulatory progress. The manufacturing milestone represents a key step in CMC readiness ahead of the planned trial and materially advances preparedness for first patient dosing. The ethics committee approval from a leading Israeli academic medical center underscores the scientific basis of SIL204. These developments are critical for investors as they de-risk the path to clinical data and potential commercialization.