Silexion Therapeutics Initiates SIL204 Clinical Trial Application in Israel
Silexion Therapeutics announced the initiation of its regulatory application in Israel for its planned Phase 2/3 clinical trial of SIL204 in patients with locally advanced pancreatic cancer, LAPC, based on the positive Scientific Advice response received from the German Federal Institute for Drugs and Medical Devices, BfArM. The submission represents a key regulatory milestone in the Company's clinical development program and advances Silexion toward initiating human trials with SIL204, which are planned for the second quarter of 2026. The application is further supported by two recently completed species toxicology studies confirming no systemic organ toxicity. Silexion plans to file regulatory applications in Germany and the European Union in the first quarter of 2026, with expansion to U.S. clinical sites anticipated following completion of the safety run-in in Israel and Germany.
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Silexion Finishes Toxicology Studies for SIL204; Phase 2/3 Trial for Pancreatic Cancer Set to Start in Q2
SIL204 Development: Silexion Therapeutics has completed toxicology studies for SIL204, a next-generation siRNA therapy targeting mutated KRAS oncogenes in pancreatic cancer, showing no systemic organ toxicity.
Therapeutic Potential: SIL204 has demonstrated significant inhibition of cancer cell growth in preclinical models and positive anti-tumor activity in pancreatic cancer, paving the way for regulatory submissions in Israel and Germany.
Clinical Trial Plans: The therapy is set to progress to a Phase 2/3 trial in Q2 2026, utilizing a unique regimen that combines intratumoral and systemic administration to evaluate safety and efficacy in patients with locally advanced pancreatic cancer.
Stock Performance: Silexion's stock has fluctuated between $2.13 and $63.45 over the past year, closing at $2.44, reflecting a 13.48% increase in recent trading.
Silexion Completes Toxicology Studies for SIL204, Plans Phase 2/3 Trial in 2026
- Successful Toxicology Studies: Silexion has completed dual-species toxicology studies for SIL204, confirming no systemic organ toxicity, which lays the groundwork for planned regulatory submissions in Israel and Germany, potentially accelerating clinical trial progress.
- Clinical Trial Timeline: The company is on track to initiate a Phase 2/3 clinical trial for locally advanced pancreatic cancer in Q2 2026, ensuring competitiveness and timely market entry in the oncology sector.
- Innovative Therapy Potential: SIL204, designed as a next-generation RNA interference therapy targeting mutant KRAS oncogenes, has demonstrated significant anti-tumor activity in vitro, indicating its substantial potential in treating aggressive cancers.
- Integrated Treatment Strategy: The company's approach combines both intratumoral and systemic administration, aiming to improve survival rates for patients suffering from high-mortality cancers that currently lack effective treatment options.
