On September 30, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that the first patient worldwide has been successfully dosed in its Phase 2/3 clinical trial evaluating the Company’s lead candidate, SIL204, in patients with locally advanced pancreatic cancer (LAPC). The treatment was administered at Tel Aviv Sourasky Medical Center ("TASMC" or "Ichilov") in Israel, marking a defining transition into active clinical execution for the Company’s global therapeutics program.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The trial is a prospective, randomized, controlled, multinational, Phase 2/3, open-label study evaluating the efficacy and safety of SIL204 administered as an integrated therapeutic regimen in combination with standard-of-care chemotherapy, versus chemotherapy alone, in patients with LAPC. The study is structured with an initial safety run-in cohort of approximately 18 patients, followed by global expansion to enroll a randomized cohort of approximately 166 patients. The trial enrolls newly diagnosed, treatment-naïve adult patients with unresectable Stage 3 LAPC without distant metastases whose tumors harbor a confirmed KRAS mutation. SIL204 is administered as a first-line regimen alongside standard chemotherapy, with the choice of chemotherapy at the treating physician’s discretion.
In this trial, SIL204 is administered via an innovative dual-route delivery strategy designed to address the anatomical and biological barriers of pancreatic tumors. Treatment combines direct intratumoral administration via an endoscopic ultrasound (EUS)-guided procedure, targeting the primary pancreatic lesion to bypass dense tumor stroma, with subcutaneous abdominal injections designed to provide systemic exposure and address potential micro-metastases.
"Successfully dosing the first patient in our Phase 2/3 clinical trial of SIL204 is a defining operational and clinical milestone for Silexion, transitioning our lead RNAi program into active patient treatment," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Locally advanced pancreatic cancer is one of the most aggressive and lethal solid tumors, with patients facing a persistent lack of new therapeutic options. By combining direct local tumor penetration with systemic coverage, our integrated regimen is engineered to overcome the critical delivery barriers that have historically limited pancreatic cancer treatments. We are thrilled to initiate dosing at Tel Aviv Sourasky Medical Center and look forward to advancing additional clinical trial sites across Israel and Germany, as we work toward preliminary clinical readouts in the near term to evaluate SIL204’s potential to improve response rates and survival outcomes for patients with locally advanced pancreatic cancer."
Tel Aviv Sourasky Medical Center serves as the anchor clinical center for the trial in Israel following receipt of institutional ethics approval and authorization from the Israeli Ministry of Health. Additional Israeli oncology centers, alongside leading academic medical institutions in Germany approved under the European Union Clinical Trials Regulation (EU CTR) framework by the Federal Institute for Drugs and Medical Devices (BfArM), are progressing through site activation and are expected to join the Phase 2/3 program in the coming months.
(Press release, Silexion Therapeutics, SEP 30, 2026, View Source [SID1234671204])