Core Insights - Silexion Therapeutics has successfully completed toxicology studies for SIL204, confirming no systemic organ toxicity, which supports the company's plans for regulatory submissions in Israel and Germany [1][2][3] - The company is on track to initiate a Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer (LAPC) in Q2 2026 [1][3] Company Overview - Silexion Therapeutics is a clinical-stage biotechnology company focused on developing RNA interference therapies for KRAS-driven cancers, particularly targeting mutated KRAS oncogenes [4] - The company previously conducted a Phase 2a clinical trial for its first-generation product, which showed a positive trend compared to chemotherapy alone [4] Product Development - SIL204 is designed as a next-generation siRNA therapy aimed at abolishing the expression of mutated KRAS proteins, which are known to drive aggressive cancers [2] - Preclinical data for SIL204 indicates significant inhibition of cancer cell growth in vitro across various KRAS mutated cell lines and positive anti-tumor activity in pancreatic cancer sites following systemic administration [2] Clinical Trial Preparation - The company has secured a contract research organization (CRO) partner for the upcoming clinical trial and is preparing regulatory submissions to health authorities in Israel and Germany [3] - The favorable safety results from the toxicology studies support Silexion's integrated treatment regimen approach, which combines intratumoral and systemic administration [3]
Silexion Therapeutics Successfully Completes Toxicology Studies for SIL204, Next-Generation RNA Silencing Therapy, Ahead of Phase 2/3 Clinical Trial in Pancreatic Cancer