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Biotechnology: Biological Products (No Diagnostic Substances)
Clinical TrialAug 4, 2026, 04:17 PM

Silexion SIL204 Shows Positive Preclinical Data, Advances to Phase 2/3

AI Summary

Silexion Therapeutics announced new positive preclinical findings for its RNAi therapy, SIL204, demonstrating multi-mechanism immune sensitization in KRAS-driven cancers. The data showed statistically significant upregulation of FAS and downregulation of HLA-G in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines. These findings, combined with previous data, support SIL204's potential as an immune sensitizer and its combination with anti-PD-(L)1 checkpoint inhibitors. Concurrently, Silexion has advanced SIL204 into Phase 2/3 clinical evaluation, with the first trial site initiated.

Key Highlights

  • SIL204 treatment led to statistically significant upregulation of FAS (CD95), an immune "death receptor."
  • SIL204 treatment resulted in statistically significant downregulation of HLA-G, an immune checkpoint.
  • Findings were observed in human KRAS-mutant pancreatic and non-small cell lung cancer cell lines across three KRAS mutations (G12D, G12V, G12C).
  • Data supports a multi-mechanism immune-sensitization signature, building on previously reported MHC-I upregulation.
  • The company initiated its first Phase 2/3 clinical trial site for SIL204 at Tel Aviv Sourasky Medical Center.
  • The findings reinforce the rationale for combining SIL204 with anti-PD-(L)1 immune checkpoint inhibitor therapies.