Silexion Therapeutics Corp. (NASDAQ:SLXN) shares climbed 5.9% on Tuesday after the company reported encouraging results from toxicology studies for its pancreatic cancer candidate SIL204, confirming the absence of systemic organ toxicity in two animal models.
The outcome marks a key milestone for the clinical-stage biotech firm, which remains on schedule to launch a Phase 2/3 trial in patients with locally advanced pancreatic cancer during the second quarter of 2026. The company said it is now finalizing regulatory filings for submission to authorities in Israel and Germany.
SIL204 is an RNA-based silencing therapy engineered to inhibit mutated KRAS oncogenes — genetic drivers that fuel some of the most lethal cancers. In preclinical testing, the treatment demonstrated strong suppression of tumor growth in multiple KRAS-mutated cancer cell lines and showed measurable anti-tumor activity in pancreatic cancer models following systemic dosing.
“Results from the toxicology studies have cleared us to maintain our planned timelines to initiate SIL204’s Phase 2/3 clinical trial in pancreatic cancer,” said Ilan Hadar, Chairman and Chief Executive Officer of Silexion. “We have recently secured our CRO partner for the trial and continue to prepare regulatory submissions to both Israel’s Ministry of Health and Germany’s Health Authority.”
Silexion stated that its dual-administration strategy — combining intratumoral delivery with systemic treatment — could potentially enhance survival outcomes for pancreatic cancer patients while aiming to preserve quality of life.