biotech / news / / The Manila Times
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.
Silexion submitted a Clinical Trial Application for SIL204 Phase 2/3 trial to Germany via CTIS.
KEY POINTS
- 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.
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