Silexion starts SIL204 Phase 2/3 in pancreatic cancer; FDA pre-IND expected Q1 2027

Silexion Therapeutics Corp

Phase 2/3 safety run-in for SIL204 in LAPC initiated July 2026; approved by Israel MoH and Germany BfArM.
Early human data expected Q4 2026; IND application and US/EU expansion planned Q1 2027.
SIL204 targets >74% of KRAS mutations in PDAC; sub-nanomolar IC50 across G12D/V/C/R and others.
Preclinical data show tumor growth inhibition, synergy with FOLFIRI, and 11-fold safety margins.
Toxicology package for marketing approval planned H2 2026; collaboration with Catalent and Axolabs for GMP supply.

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