Core Insights - Silexion Therapeutics Corp. has announced an expanded development plan for its next-generation siRNA candidate, SIL204, targeting KRAS-driven pancreatic cancer through both systemic and intratumoral administration [1][2][3] Development Strategy - The expanded plan is based on promising preclinical findings that show SIL204 significantly inhibits tumor growth in relevant models of pancreatic cancer [2][5] - The dual-route approach aims to tackle the aggressive nature of KRAS-driven cancers, which have high mortality rates and limited treatment options [2] Clinical Development Timeline - Silexion plans to initiate human trials in the first half of 2026, following additional toxicology and pharmacodynamic studies throughout 2025 [3][5] - Regulatory submissions are expected to be made to the Israel Ministry of Health in the second half of 2025 and to the European Union in the first half of 2026 [3] Preclinical Data Support - The first-generation product, siG12DLoder, demonstrated an overall survival benefit in Phase 2 clinical trials, providing a foundation for SIL204 [5] - Recent studies indicate that subcutaneous administration of SIL204 significantly reduces metastases to secondary organs in orthotopic models, with sustained drug levels observed for approximately two months post-administration [5] Industry Engagement - The expanded development plan and recent preclinical developments will be presented at the Cancer Advocacy Group of Louisiana NeauxCancer 2025 Conference [6][7] Company Overview - Silexion Therapeutics is focused on developing RNA interference therapies for solid tumors driven by KRAS mutations, with a commitment to improving outcomes for patients with difficult-to-treat cancers [8]
Silexion Therapeutics Unveils Innovative Expanded Development Plan for SIL204 Based on Recent Groundbreaking Preclinical Data