Silexion Therapeutics Corp. (NASDAQ: SLXN) is expanding the development plan for its next-generation siRNA candidate, SIL204, to treat KRAS-driven pancreatic cancer. The new plan incorporates both systemic and intratumoral administration, targeting metastases and primary tumors, respectively, based on positive preclinical data showing significant tumor growth inhibition. This dual-route approach builds upon promising Phase 2 clinical results from Silexion’s first-generation product, siG12DLoder.
This development is crucial due to the aggressive and deadly nature of KRAS-driven cancers, coupled with the current lack of effective treatments. The dual-pronged strategy of targeting both the primary tumor and metastases directly addresses a critical unmet need in pancreatic cancer therapy, potentially improving patient outcomes and survival rates. This approach signifies a potential shift in how this challenging cancer is treated, moving beyond single-target strategies to a more comprehensive, multi-front attack.
Silexion plans to conduct additional toxicology and pharmacodynamic studies in 2025. Regulatory submissions are planned for the Israel Ministry of Health in the second half of 2025 and the European Union in the first half of 2026. Human trials are targeted to commence in the first half of 2026. Preclinical data for SIL204 demonstrates significant reduction in metastases in orthotopic models and sustained drug levels in secondary tumors for approximately two months after a single subcutaneous administration. This long-lasting effect suggests potential benefits in reducing treatment frequency and improving patient convenience.
This expanded development plan signifies a substantial advancement in Silexion’s pipeline and positions the company as a leader in developing innovative KRAS-targeted therapies. The dual-route strategy holds the promise of significantly improving the treatment landscape for pancreatic cancer and potentially other KRAS-driven cancers. The planned clinical trials will be a crucial step in validating this approach and ultimately determining the real-world impact on patient survival and quality of life.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
