Global Phase 2/3 trial evaluates SIL204 in combination with standard chemotherapy in patients with locally advanced pancreatic cancer

Integrated regimen combines direct EUS-guided intratumoral delivery to penetrate tumor stroma with subcutaneous dosing; first patient treated at Tel Aviv Sourasky Medical Center (Ichilov)

Grand Cayman, Cayman Islands and Ramat Gan, Israel, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ:SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today announced 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.

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.