Grand Cayman, Cayman Islands — November 25, 2025 — Leads & Copy — Silexion Therapeutics Corp. (NASDAQ: SLXN) announced the successful completion of toxicology studies for its next-generation RNA silencing (siRNA) therapy, SIL204, designed to target mutated KRAS oncogenes.
The two-species toxicology studies confirmed no systemic organ toxicity, moving the company closer to planned regulatory submissions in Israel and Germany. Silexion remains on track to begin a Phase 2/3 clinical trial in locally advanced pancreatic cancer (LAPC) in the second quarter of 2026.
SIL204 is engineered to abolish expression of mutated KRAS proteins, which drive aggressive cancers. Preclinical data has demonstrated significant inhibition of cancer cell growth in vitro across a broad range of KRAS mutated cell lines. SIL204 has also shown anti-tumor activity in pancreatic cancer sites after systemic administration.
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, stated that the toxicology study results allow the company to maintain its timelines for initiating the Phase 2/3 clinical trial in pancreatic cancer. He noted that a CRO partner has been secured for the trial and the company is preparing regulatory submissions for Israel’s Ministry of Health and Germany’s Health Authority (BfArM).
Hadar added that SIL204’s preclinical package has shown potential as a cancer treatment by stopping mutated, cancer-driving proteins before expression. The company is eager to demonstrate this potential in clinical trials to bring SIL204 to patients.
Dr. Mitchell Shirvan, Chief Scientific and Development Officer of Silexion, said that the favorable safety results support the company’s integrated treatment regimen approach, which combines intratumoral and systemic administration. He believes that this approach, along with Silexion’s platform for disrupting communication between the KRAS oncogene and tumor cells, could improve survival and quality of life for patients.
Silexion Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for solid tumor cancers with the mutated KRAS oncogene. The company’s first-generation product showed a positive trend in a Phase 2a clinical trial compared to chemotherapy alone.
Silexion is dedicated to advancing therapeutic solutions in oncology and further developing its lead product candidate for LAPC.
Ms. Mirit Horenshtein Hadar, CFO, mirit@silexion.com
Arx Investor Relations, North American Equities Desk, silexion@arxhq.com
Source: Silexion Therapeutics Corp
