WSW, NY, July 29th, 2026, FinanceWire
Silexion Therapeutics (NASDAQ: SLXN) just announced that it initiated its Phase 2/3 clinical trial of SIL204 at Tel Aviv Sourasky Medical Center (TASMC, commonly known as Ichilov), one of Israel’s premier oncology research centers. Site initiation clears TASMC to begin patient screening in the coming weeks, with first patient dosing anticipated to follow. For a company that has spent years assembling a pan-KRAS RNA interference candidate against a target the industry called “undruggable” for nearly four decades, this is the day the paperwork ends and the patients begin.
The activation at Ichilov caps a roughly four-month sprint in which Silexion cleared every remaining readiness gate for the SIL204 program: Israeli Ministry of Health authorization on March 24, 2026, followed by the initiation of GMP clinical supply manufacturing with Catalent at its Limoges, France center of excellence in May, TASMC’s own institutional ethics approval that same month, Germany’s BfArM authorization in June, and today’s formal site activation. Additional Israeli and German centers are advancing through activation in parallel. In the Company’s own framing, that transitions the SIL204 program from regulatory preparation into active clinical execution.
Ichilov is not a placeholder site. It is one of Israel’s largest teaching hospitals, one of its most active oncology research institutions, and serves as the anchor site for the Israeli arm of Silexion’s Phase 2/3 program. Anchoring the first activation at a leading academic medical center signals that the Israeli oncology community has taken the trial through full institutional review, and gives SIL204 a credibility platform for the additional Israeli and German sites lined up behind it.
The trial design
The Phase 2/3 study aimes to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with locally advanced pancreatic cancer (LAPC), a stage where the disease has progressed beyond surgical resection but has not yet spread widely. It is structured as a safety run-in cohort of approximately 18 patients, followed by expansion into sites worldwide to obtain a randomized cohort of approximately 166. The dosing strategy uses Silexion’s dual-route approach: intratumoral delivery designed to overcome the stromal barrier that limits systemic drug penetration into the pancreatic primary tumor, alongside systemic administration intended to address metastatic disease. That framework is engineered for pancreatic cancer biology specifically. Five-year survival sits below 13%, and more than 80% of mortality is driven by metastatic disease.
KRAS is one of the most common oncogenic drivers in human cancer, present in approximately 90% of pancreatic cancers, 45% of colorectal, and 30 to 35% of lung adenocarcinomas. For nearly four decades, its smooth protein surface defied conventional small-molecule inhibitor design. The first real cracks came with sotorasib (Amgen) and adagrasib (Mirati) against KRAS G12C. But G12C represents only around 1 to 2% of pancreatic cases. The dominant pancreatic mutations, G12D, G12V, and G12R, remain effectively unaddressed by approved targeted therapy. SIL204 is not a small molecule. It is a small interfering RNA (siRNA) engineered to silence mutated KRAS messenger RNA before the cancer-driving protein is made, the same class of biology behind Alnylam’s approved RNAi drugs. Because RNAi targets a genetic sequence rather than a protein shape, SIL204 can be designed to hit a broad swath of mutations in a single molecule.
The preclinical and clinical foundation
In preclinical human cell line studies previously reported by the Company, SIL204 has shown up to 99.7% inhibition of cancer cell growth, with reported activity across eight KRAS mutations including G12D, G12V, G12R, and G12C, and across pancreatic, colorectal, lung, gastric, and additional KRAS-driven models. Preclinical data does not predict clinical outcomes, but that breadth is what makes SIL204 a pan-KRAS candidate rather than a mutation-specific one. This is also not Silexion’s first pass at the disease. According to Company reporting, its predecessor compound LODER ran a Phase 2 trial in LAPC in which patients receiving LODER alongside standard-of-care chemotherapy showed a 9.3-month improvement in overall survival, a 56% objective response rate, and a 67% resectability rate in tumors previously deemed inoperable. Past clinical results do not predict future outcomes.
The clinical calendar for Silexion has now shifted meaningfully. From today forward, the milestones may stop being preparatory and start being clinical: patient screening, first patient dosing, additional site activations, and eventually safety and interim data. The risks are real. Pancreatic cancer trials are notoriously difficult, translation from preclinical models to patients is never assured, RNAi delivery in solid tumors is a known challenge, site timelines can slip, and as a microcap, financing and execution will matter as much as biology. But the story from here is now one with clinical data in its pipeline rather than just regulatory paperwork, and for a microcap approaching first human data in one of oncology’s hardest indications, that is a chapter worth watching closely.
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