GRAND CAYMAN, Cayman Islands, Sept. 11, 2025 – Silexion Therapeutics Corp. (NASDAQ: SLXN), a clinical-stage biotechnology company developing RNA interference (RNAi) therapies, announced positive preclinical data showing that its lead candidate SIL204 successfully reached major metastatic sites of pancreatic cancer and reduced tumor burden at clinically relevant doses. The results support the company’s dual-route administration strategy and advance SIL204 toward planned Phase 2/3 trials in 2026.
Science Significance
The new findings demonstrate that subcutaneously administered SIL204 distributed effectively to the liver, peritoneum, and lung — primary sites of pancreatic cancer metastasis — with measurable anti-tumor activity. In a mouse model harboring KRAS G12D mutations, statistically significant tumor reductions were observed, validating SIL204’s systemic potential. This complements earlier intratumoral efficacy data, supporting a dual-route approach aimed at treating both primary tumors and disseminated metastatic disease.
As over 80% of pancreatic cancer deaths are attributed to metastases, SIL204’s demonstrated biodistribution provides a strong scientific rationale for advancing to human trials.
Regulatory Significance
Silexion is preparing regulatory submissions in Q4 2025 and Q1 2026 to enable Phase 2/3 clinical trials in the first half of 2026. These submissions will outline SIL204’s preclinical safety and efficacy profile, its dual-route administration framework, and proposed study protocols. The ability to demonstrate results at human-equivalent dosing strengthens the package for regulatory review by agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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Business Significance
Silexion’s announcement underscores the company’s position as a leading innovator in RNAi-based oncology therapeutics. The validation of SIL204’s systemic activity enhances its commercial potential, particularly in the pancreatic cancer market where treatment options are limited and outcomes remain poor. The company is also conducting expanded studies in multiple cancer types and KRAS mutations, suggesting broader pipeline opportunities.
By demonstrating clinically relevant preclinical efficacy, Silexion strengthens its standing with investors, prospective partners, and regulatory authorities — an important step as it advances toward pivotal trials.
Patients’ Significance
For patients, particularly those facing pancreatic cancer with high risk of metastasis, SIL204 represents a potential new therapeutic option addressing a major unmet need. Nearly 40% of patients who undergo surgery relapse within a year, often with distant metastases. Current treatments struggle to address micrometastases effectively, leaving patients with limited alternatives.
If successful in clinical trials, SIL204 could offer a dual-action therapy: intratumoral delivery for primary tumor control and systemic administration for metastatic disease suppression, giving patients new hope against this highly aggressive cancer.
Policy Significance
The development of SIL204 aligns with global health policy priorities that emphasize innovation in oncology and unmet medical needs. Breakthroughs in pancreatic cancer treatment are specifically targeted by cancer research initiatives in the U.S., EU, and Asia, where incidence rates are rising. As policymakers look to accelerate access to next-generation cancer therapies, Silexion’s RNAi-based approach could attract support under orphan drug and expedited regulatory pathways.
Transaction Highlights
In its latest announcement, Silexion highlighted a series of important preclinical milestones supporting the advancement of SIL204. The study confirmed that subcutaneously administered SIL204 successfully reached the liver, peritoneum, and lung, the most common metastatic sites in pancreatic cancer, with statistically significant reductions in tumor burden achieved at clinically relevant doses. These results address the long-standing challenge of targeting micrometastases, which account for the majority of pancreatic cancer mortality. In parallel, the company is conducting expanded research across additional KRAS-driven cancers to further characterize SIL204’s pan-KRAS therapeutic potential. With regulatory submissions scheduled for late 2025 and early 2026, Silexion remains on track to initiate Phase 2/3 clinical trials in the first half of 2026, marking a pivotal step in its mission to deliver a dual-route therapy designed to treat both primary tumors and metastatic disease.
Source: Silexion Therapeutics Corp. Press Release
