Latest preclinical results validate systemic delivery approach, positioning SIL204 for Phase 2/3 initiation in first half of 2026
Silexion Therapeutics (NASDAQ: SLXN) today announced groundbreaking preclinical data demonstrating that its leading asset SIL204 successfully reaches all primary sites of pancreatic cancer metastasis following systemic administration, marking a pivotal advancement as the clinical-stage biotechnology company prepares for Phase 2/3 trials in the first half of 2026.
The new findings represent a critical validation of the systemic component of Silexion’s innovative dual-route administration strategy, which combines intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. In a metastatic pancreatic cancer mouse model using bioluminescent imaging, SIL204 demonstrated successful distribution to the liver, peritoneum, and lung with measurable reductions in tumor burden across multiple sites at clinically relevant doses.
The importance of these results becomes clear when considering the challenges of pancreatic cancer treatment, where over 80 percent of mortality is attributed to metastatic disease and more than 40 percent of initially resectable patients experience recurrence within 12 months, predominantly as distant metastases. The ability to systemically target these widespread cancer cells represents a fundamental breakthrough in addressing one of oncology’s most challenging malignancies.
“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, Chief Scientific Officer of Silexion. The study achieved statistically significant reductions in tumor burden in the peritoneum, lung, and intestine, while the liver, the most common site of pancreatic cancer metastasis, showed measurable reduction following a single subcutaneous injection.
The timing of this announcement positions Silexion at a critical juncture as the company advances toward regulatory submissions planned for the fourth quarter of 2025 to the Israel Ministry of Health and the first quarter of 2026 to the European Union. The company recently selected AMS Advanced Medical Services as its contract research organization, bringing over 28 years of drug development experience and proven Phase 3 oncology trial expertise to support the upcoming pivotal study.
This latest data builds upon a series of remarkable preclinical achievements that have established SIL204 as a potentially transformative pan-KRAS therapeutic. Recent studies have demonstrated unprecedented inhibition rates of up to 97 percent in pancreatic cancer cells, with the therapy showing robust activity against multiple KRAS mutations including G12D, G12V, G12R, Q61H, and G13D across pancreatic, colorectal, and lung cancer models. These three cancer types collectively represent global treatment markets worth over 30 billion dollars annually, yet most KRAS variants remain difficult to target with conventional therapeutic approaches.
The company’s strategic positioning has been further strengthened through its collaboration with global therapeutics leader Catalent for advanced siRNA formulation development and clinical manufacturing activities. This partnership, announced in April, focuses on optimizing both systemic and intratumoral delivery formulations of SIL204 at Catalent’s state-of-the-art facility in Limoges, France.
Silexion’s approach represents a fundamental departure from traditional KRAS targeting strategies. While small molecule inhibitors attempt to target already-produced mutant KRAS proteins, SIL204 employs RNA interference to silence the production of oncogenic KRAS at the genetic level, preventing the formation of these cancer-driving proteins at their source. This innovative mechanism, combined with the company’s dual-route delivery system, positions SIL204 to comprehensively address both primary and metastatic disease.
The market opportunity for effective KRAS-targeting therapies continues to expand, with the precision medicine market projected to grow from 102 billion dollars in 2024 to 470 billion dollars by 2034. Recent high-profile acquisitions in the precision oncology space, including Pfizer’s 43 billion dollar purchase of Seagen and AbbVie’s 10.1 billion dollar acquisition of Immunogen, underscore the industry’s appetite for innovative cancer therapeutics.
Chairman and CEO Ilan Hadar emphasized the clinical importance of the new findings, stating that the data “addresses a fundamental challenge in pancreatic cancer treatment – reaching micrometastases that have spread beyond the primary tumor.” Combined with previously reported intratumoral efficacy data, the company now possesses evidence supporting both components of its comprehensive treatment approach designed to address this aggressive disease.
As Silexion advances toward its planned regulatory submissions and Phase 2/3 trial initiation, the company continues conducting expanded tissue culture studies across multiple cancer types and KRAS mutations to further characterize SIL204’s pan-KRAS potential, with additional results expected in the near future.
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