Silexion Therapeutics Reports Positive Preclinical Data Demonstrating SIL204’s Reach & Activity in Major Pancreatic Cancer Metastatic Sites Following Systemic Administration

Silexion Therapeutics Corp. recently announced new preclinical data demonstrating that subcutaneously administered SIL204 successfully reaches all primary sites of pancreatic cancer metastasis and shows anti-tumor activity.

The study evaluated SIL204’s biodistribution and therapeutic activity following subcutaneous administration in a metastatic pancreatic cancer mouse model using bioluminescent imaging. Results confirmed that SIL204 distributed to key organs where pancreatic cancer commonly spreads, with measurable reductions in tumor burden observed across multiple sites.

The ability to reach metastatic sites is particularly important given that over 80% of pancreatic cancer mortality is attributed to metastatic disease, and more than 40% of initially resectable patients experience recurrence within 12 months, predominantly as distant metastases.

“These findings provide additional validation for a critical component of our dual-route administration strategy – the ability of subcutaneously delivered SIL204 to reach metastatic sites throughout the body,” said Mitchell Shirvan, PhD, Chief Scientific Officer of Silexion. “Demonstrating drug distribution to the liver, peritoneum, and lung, which represent the primary sites of metastatic pancreatic cancer spread, supports our approach of combining intratumoral delivery for primary tumors with systemic administration for disseminated disease.”

Key Study Findings:

• SIL204 successfully distributed to all major metastatic sites following a single subcutaneous injection at 5mg/mouse (mid-range human equivalent dose for planned clinical trials)
• Reductions in bioluminescent signal, indicating decreased tumor burden, were observed at day 7 across all evaluated organs
• Statistically significant reductions (p<0.01) were achieved in the peritoneum (mesentery), lung, and intestine
• The liver, the most common site of pancreatic cancer metastasis, showed measurable reduction in tumor burden
• Studies utilized human pancreatic cancer cells (Panc-1) harboring the KRAS G12D mutation
• The use of human equivalent dosing demonstrates that these results were achieved at drug concentrations directly relevant to planned clinical use, providing important validation for the transition from preclinical to human studies

“This data addresses a fundamental challenge in pancreatic cancer treatment – reaching micrometastases that have spread beyond the primary tumor,” added Ilan Hadar, Chairman and CEO of Silexion. “Combined with our previously reported intratumoral efficacy data, we now have evidence supporting both components of our treatment approach designed to comprehensively address this aggressive disease.”

The company is also conducting expanded tissue culture studies across multiple cancer types and KRAS mutations to further characterize SIL204’s pan-KRAS potential, with results expected in the near future.

Silexion remains on track to initiate Phase 2/3 clinical trials evaluating its dual-route administration approach in the first half of 2026, with regulatory submissions planned for Q4 2025 and Q1 2026.

Silexion Therapeutics is a pioneering clinical stage, oncology-focused biotechnology company dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene, generally considered to be the most common oncogenic gene driver in human cancers. The company conducted a Phase 2a clinical trial in its first-generation product which showed a positive trend in comparison to the control of chemotherapy alone. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer. For more information please visit: https://silexion.com.