Silexion Therapeutics Corp. (NASDAQ: SLXN) reported that the first patient worldwide has been successfully dosed in its Phase 2/3 clinical trial of SIL204 for locally advanced pancreatic cancer. The treatment was administered at Tel Aviv Sourasky Medical Center in Israel, marking the start of active clinical execution for the company's lead RNA interference candidate.
The study is a prospective, randomized, controlled, and open-label evaluation of SIL204 combined with standard chemotherapy against chemotherapy alone in patients with locally advanced pancreatic cancer. The trial structure includes an initial safety run-in cohort of approximately 18 patients, followed by a global expansion to a randomized cohort of approximately 166 patients. Enrollment is limited to newly diagnosed, treatment-naïve adults with unresectable Stage 3 locally advanced pancreatic cancer without distant metastases, specifically those with confirmed KRAS mutations.
SIL204 is administered as a first-line regimen alongside chemotherapy, with the specific chemotherapy regimen chosen at the treating physician's discretion. The delivery strategy combines direct intratumoral administration via endoscopic ultrasound-guided procedure with subcutaneous abdominal injections. This dual-route approach is designed to bypass dense tumor stroma in the primary lesion while providing systemic exposure to address potential micro-metastases.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics, stated that dosing the first patient represents a defining operational and clinical milestone. He noted that locally advanced pancreatic cancer remains one of the most aggressive solid tumors with limited new therapeutic options. Hadar said the integrated regimen is engineered to overcome delivery barriers that have historically limited treatments in this area. The company plans to advance additional clinical trial sites across Israel and Germany.
Tel Aviv Sourasky Medical Center serves as the anchor clinical center in Israel following institutional ethics approval and authorization from the Israeli Ministry of Health. Additional Israeli oncology centers and academic medical institutions in Germany are progressing through site activation under the European Union Clinical Trials Regulation framework. These German sites have received approval from the Federal Institute for Drugs and Medical Devices and are expected to join the program in coming months.
Silexion Therapeutics is a clinical-stage biotechnology company focused on RNA interference therapies for KRAS-driven cancers. The company previously conducted a Phase 2a trial of its first-generation product candidate, which showed a positive trend compared to chemotherapy alone. SIL204 is the company's second-generation small interfering RNA candidate currently advancing through Phase 2/3 evaluation.
The company's press release includes forward-looking statements regarding clinical development, enrollment, and anticipated outcomes. These statements involve risks and uncertainties, including the ability to enroll patients as planned, the possibility that preliminary data may not confirm early observations, and the ability to complete site activation on anticipated timelines. Actual results may differ materially from those projected.