Silexion Therapeutics reports breakthroughs from SIL-204 preclinical studies

Silexion Therapeutics announced new preclinical findings for SIL-204, its second-generation siRNA candidate, following the optimization of its extended-release formulation. These latest findings demonstrate that the latest SIL-204-microparticle formulation can inhibit the growth and induce necrosis of the human pancreatic cell line that bears the KRAS G12D mutation xenotransplanted into mice. Given that this mutation constitutes the largest segment of pancreatic cancer subtypes, it represents a significant in the development of SIL-204. Key new pre-clinical findings include: Significant Anti-tumor Activity: In recent mouse xenograft studies, SIL-204 demonstrated substantial tumor reduction in the human pancreatic tumor cell lines with the KRAS G12D mutations using the innovative approach of oncogene silencing with siRNA. Previous studies showed this effect using unformulated siRNA with daily injections. The new studies further show this effect with a single administration of SIL-204 encapsulated in an extended-release formulation. Moreover, histopathological examination of treated tumors showed a very high induction of tumor necrosis. Improved Formulation In Vivo: The transition from PLGA depot rods to PLGA microparticles has resulted in a superior extended-release profile, enhancing the therapeutic potential. We now report in vivo results indicating that our new modified PLGA-microparticle formulation has superior properties over previous extended-release formulations. Silexion plans to initiate toxicology studies with SIL-204 within the upcoming months and has plans to advance SIL-204 into Phase 2/3 clinical trials in the first half of 2026, focusing initially on locally advanced pancreatic cancer which has a notoriously high mortality rate. In parallel, the company plans to initiate preclinical studies for SIL-204, in colorectal cancer models.