# CTA submission positions Silexion for European Phase 2/3 trial of SIL204 in KRAS-driven pancreatic cancer, with Germany serving as Reference Member State for the EU program.

*biotech · news · 2026-04-28 · The Manila Times*

## Key points

- Silexion submitted a Clinical Trial Application for SIL204 Phase 2/3 trial to Germany via CTIS.
- Germany will serve as Reference Member State for the EU scientific assessment of the SIL204 trial.
- Two-species toxicology studies for SIL204 showed no systemic organ toxicity supporting the trial submission.
- The planned Phase 2/3 trial uses dual-route siRNA administration: intratumoral and systemic in LAPC patients.
- SIL204 trial will start in Q2 2026 across top oncology centers in Germany, EU, and Israel.

**Companies:** Silexion Therapeutics Corp.
**Countries:** Germany, Israel

[Read the full story on The Manila Times](https://www.manilatimes.net/2026/04/28/tmt-newswire/globenewswire/silexion-therapeutics-announces-successful-submission-of-phase-23-clinical-trial-application-to-germanys-bfarm-for-sil204-in-kras-driven-locally-advanced-pancreatic-cancer/2330453)

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