Silexion Therapeutics is a clinical-stage biotech developing RNA-based cancer treatments targeting KRAS, one of the most common cancer-driving gene mutations. Rather than inhibiting the KRAS protein after it is produced — the approach most competitors take — Silexion uses small interfering RNA (siRNA) technology to silence the KRAS gene itself, preventing the oncogenic protein from being made in the first place. Silexion's lead candidate, SIL204, targets the two most common KRAS mutations in pancreatic cancer (G12D and G12V), and its initial target indication is locally advanced pancreatic cancer (LAPC), where tumors cannot be surgically removed but have not yet spread to other organs. SIL204 is delivered via a dual-route approach Silexion calls its Integrated Treatment Regimen: direct intratumoral injection (bypassing the dense fibrous tissue surrounding pancreatic tumors) combined with subcutaneous injection to address disease spread beyond the primary tumor, both used alongside standard chemotherapy. Silexion has no approved products and no revenue. The company is preparing to initiate a Phase 2/3 trial of SIL204 in Q2 2026, with a U.S. IND submission planned for Q1 2027. If SIL204 is eventually approved, Silexion would pursue either direct commercialization targeting oncologists and gastroenterologists, or partnering and licensing arrangements with larger pharma companies. Silexion is also pursuing Orphan Drug Designation in the U.S. and EU, which would provide up to seven and ten years of post-approval marketing exclusivity, respectively. SIL204's patent protection runs until 2043, with potential extensions to 2048.