Silexion submits Phase 2/3 trial application to Germany's BfArM for SIL204 in KRAS-driven pancreatic cancer

Silexion Therapeutics Corp

Silexion submitted CTA to Germany’s BfArM for Phase 2/3 trial of SIL204 in KRAS-driven locally advanced pancreatic cancer.
Germany will serve as EU Reference Member State; trial initiation remains on track for Q2 2026.
Submission supported by completed two-species toxicology studies confirming no systemic organ toxicity.
Planned trial will evaluate SIL204 in combination with standard chemotherapy using dual-route administration.
Pancreatic cancer has <13% five-year survival; KRAS mutations present in about 90% of cases.

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