1. Silexion initiates regulatory submission for SIL204 clinical trial in Israel. 2. Positive feedback received from German authorities supports trial advancement. 3. SIL204 shows up to 99.7% cancer cell inhibition in preclinical studies. 4. Phase 2/3 trial expected to start in Q2 2026. 5. Plans for regulatory filings in Germany and the EU by Q1 2026.
FAQ
Why Bullish?
The regulatory submission and encouraging preclinical data suggest strong potential for SIL204, similar to past biotech successes like Moderna's early pipeline developments which were met with bullish market reactions.
How important is it?
Silexion's advancement towards clinical trials with promising data provides a strong foundation for potential future growth and investment interest.
Why Long Term?
While immediate impact is positive, full results from clinical trials and eventual market adoption will take time, hence long-term influence.
Silexion Therapeutics Submits Phase 2/3 Clinical Trial Application in Israel for SIL204 Targeting Locally Advanced Pancreatic Cancer
On December 16, 2025, Silexion Therapeutics (NASDAQ: SLXN), a clinical-stage biotechnology company focused on RNA-based therapies within oncology, announced the submission of its regulatory application in Israel for the Phase 2/3 clinical trial of its promising candidate, SIL204, aimed at treating locally advanced pancreatic cancer (LAPC). This milestone follows positive feedback from the German Federal Institute for Drugs and Medical Devices (BfArM) and successful toxicology studies.
Key Milestones and Future Plans
The submission of the clinical trial application is a critical step in Silexion’s development program, propelling the company toward human trial initiation currently scheduled for the second quarter of 2026. This decision is bolstered by:
- Completion of two species toxicology studies, confirming no systemic organ toxicity.
- Plans for regulatory submissions in Germany and the European Union by Q1 2026.
- Potential expansion into U.S. clinical sites after the safety run-in concludes in Israel and Germany.
Collaboration with Sheba Medical Center
The clinical trial in Israel is being conducted in cooperation with Sheba Medical Center, recognized as one of the top ten hospitals worldwide by Newsweek. The company intends to carry out the Israeli segment of the Phase 2/3 clinical trial at this prestigious facility, pending the necessary regulatory and ethical approvals.
Comments from Leadership
Ilan Hadar, Chairman and Chief Executive Officer of Silexion, emphasized the importance of this regulatory request: "The submission of the regulatory request to initiate human studies in Israel with Sheba Medical Center marks a pivotal moment for Silexion. It signifies the transition of SIL204 from preclinical development into advanced clinical trials. Our preclinical data has shown up to 99.7% inhibition across various KRAS mutations, and with positive feedback from German authorities and our completed safety package, we believe SIL204 is well-poised to meet the substantial unmet need in locally advanced pancreatic cancer." He added, "This submission marks our final milestone for 2025, and I am proud of our team's exceptional execution throughout this transformative year."
About SIL204 and Its Mechanism
SIL204 represents Silexion’s next-generation small interfering RNA (siRNA) therapy designed to silence mutated KRAS oncogenes, which are common drivers of human cancers. The planned Phase 2/3 trial will assess an innovative dual-route administration method, which combines intratumoral delivery to target primary tumors with systemic administration to address metastatic disease.
Company Background
Silexion Therapeutics is a groundbreaking, oncology-focused biotechnology firm committed to developing novel treatments for solid tumor cancers characterized by mutated KRAS oncogenes. The company previously conducted a Phase 2a clinical trial with its first-generation product, yielding favorable outcomes compared to conventional chemotherapy. Silexion remains dedicated to advancing its lead product candidate for locally advanced pancreatic cancer, driving forward innovations in the oncology landscape.
For more details, visit: silexion.com.
Forward-Looking Statements
This press release contains forward-looking statements, including those regarding regulatory submissions and the expected timeline for the Phase 2/3 clinical trial of SIL204. Actual results may differ materially from those projected due to various risks and uncertainties. Interested parties should review the risks set forth in Silexion's filings with the SEC, including the Company's Annual Report on Form 10-K.