Silexion Files Phase 2/3 CTA with Germany’s BfArM for SIL204 in Pancreatic Cancer
Silexion submitted a Phase 2/3 Clinical Trial Application to Germany’s BfArM for SIL204 in KRAS-driven locally advanced pancreatic cancer, supported by toxicology data confirming no systemic organ toxicity. The Q2 2026 study will combine intratumoral and systemic administration of SIL204 with chemotherapy at sites in Germany, EU countries and Israel.
1. Clinical Trial Application Submission
Silexion submitted a Clinical Trial Application on April 28, 2026, to Germany’s Federal Institute for Drugs and Medical Devices (BfArM) for its Phase 2/3 trial of SIL204 in KRAS-driven locally advanced pancreatic cancer, marking its entry into the European regulatory process.
2. Regulatory Package and Preclinical Data
The submission is supported by a comprehensive dossier including two-species toxicology studies that confirmed no systemic organ toxicity and extensive preclinical efficacy data on SIL204’s RNA interference mechanism targeting mutated KRAS.
3. Upcoming Phase 2/3 Study Design
The planned trial will initiate in Q2 2026 with a safety run-in followed by a randomized cohort, evaluating intratumoral and systemic administration of SIL204 in combination with standard chemotherapy across sites in Germany, EU countries and Israel.
4. Strategic Implications and Timeline
With Germany serving as Reference Member State under the EU Clinical Trials Regulation and Israeli approval in place, Silexion aims to leverage rigorous regulatory assessments to support simultaneous trial initiation across multiple jurisdictions as per its 2026 roadmap.