Silexion activates first site for SIL204 pancreatic cancer trial in Israel

Silexion Therapeutics Corp announced on July 29, 2026 the successful initiation of its Phase 2/3 clinical trial of SIL204, its lead small interfering RNA product candidate, at Tel Aviv Sourasky Medical Center, known as TASMC or Ichilov, formally activating the first clinical site for the study in patients with locally advanced pancreatic cancer.¹

With the site now active, TASMC is cleared to begin screening patients for enrollment.¹ The activation followed receipt of all regulatory and institutional approvals needed to open the site, including Israeli Ministry of Health authorization received on March 24, 2026, and TASMC's own ethics approval, confirming that Silexion's investigational medicinal product for SIL204 is available in Israel.¹

The company said this milestone capped roughly four months of clinical readiness steps, including the March 2026 Israeli Ministry of Health approval, the start of GMP clinical supply manufacturing with Catalent announced in May 2026, TASMC's ethics approval announced in May 2026, and Germany's BfArM authorization received in June 2026.¹

Silexion said the program is now moving from regulatory preparation into active clinical execution, with additional sites in Israel and Germany progressing toward activation and first patient dosing expected as the next milestone.¹

The trial itself is designed to test SIL204 alongside standard chemotherapy in locally advanced pancreatic cancer patients, using a dual-route administration approach that combines intratumoral delivery with systemic dosing, starting with a safety run-in cohort of about 18 patients before expanding to a randomized cohort of about 166 patients worldwide.¹

Silexion noted that KRAS mutations occur in about 90% of pancreatic cancers, 45% of colorectal cancers, and 30-35% of lung adenocarcinomas, and that pancreatic cancer has a five-year survival rate below 13%, with more than 80% of related deaths driven by metastatic disease.¹