Silexion Therapeutics to Initiate SIL204 Clinical Trials in 2025
Silexion Therapeutics released a letter to shareholders from Chairman and Chief Executive Officer, Ilan Hadar. "2025 was a transformational year for Silexion Therapeutics. We positioned our lead asset, SIL204, to enter human clinical trials in the first half of 2026, bringing us significantly closer to delivering breakthrough treatments for some of the most aggressive and difficult-to-treat cancers... We believe the long-term broader addressable market for our solution may exceed $30 billion annually when considering pancreatic, colorectal, and lung cancer treatment globally... Throughout 2025, we generated compelling preclinical evidence demonstrating SIL204's exceptional potency and broad applicability. Our pre-clinical results showed significant inhibition of cancer cell growth in human cancer cell line models, which consistently exceeded 90% across multiple models. We validated activity against eight distinct KRAS mutations, including G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D... As recently reported, we have completed our regulatory submissions in Israel to initiate our Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer. We anticipate receiving a response during the first quarter of 2026, with clinical trial commencement planned for the first half of 2026. Additional regulatory submissions to Germany are planned for the first quarter of 2026, with additional European Union submissions expected later in 2026 and a U.S. IND submission anticipated in the second half of 2026... We believe that the human data generated during the first stage of our clinical program in 2026 will be critical in demonstrating the potential of our approach and may serve as a foundation for future strategic collaborations and financing as we work to advance SIL204 toward a first-in-class and first-line therapy for pancreatic cancer."
Trade with 70% Backtested Accuracy
Analyst Views on SLXN
About SLXN
About the author
Silexion Finishes Toxicology Studies for SIL204; Phase 2/3 Trial for Pancreatic Cancer Set to Start in Q2
SIL204 Development: Silexion Therapeutics has completed toxicology studies for SIL204, a next-generation siRNA therapy targeting mutated KRAS oncogenes in pancreatic cancer, showing no systemic organ toxicity.
Therapeutic Potential: SIL204 has demonstrated significant inhibition of cancer cell growth in preclinical models and positive anti-tumor activity in pancreatic cancer, paving the way for regulatory submissions in Israel and Germany.
Clinical Trial Plans: The therapy is set to progress to a Phase 2/3 trial in Q2 2026, utilizing a unique regimen that combines intratumoral and systemic administration to evaluate safety and efficacy in patients with locally advanced pancreatic cancer.
Stock Performance: Silexion's stock has fluctuated between $2.13 and $63.45 over the past year, closing at $2.44, reflecting a 13.48% increase in recent trading.
Silexion Completes Toxicology Studies for SIL204, Plans Phase 2/3 Trial in 2026
- Successful Toxicology Studies: Silexion has completed dual-species toxicology studies for SIL204, confirming no systemic organ toxicity, which lays the groundwork for planned regulatory submissions in Israel and Germany, potentially accelerating clinical trial progress.
- Clinical Trial Timeline: The company is on track to initiate a Phase 2/3 clinical trial for locally advanced pancreatic cancer in Q2 2026, ensuring competitiveness and timely market entry in the oncology sector.
- Innovative Therapy Potential: SIL204, designed as a next-generation RNA interference therapy targeting mutant KRAS oncogenes, has demonstrated significant anti-tumor activity in vitro, indicating its substantial potential in treating aggressive cancers.
- Integrated Treatment Strategy: The company's approach combines both intratumoral and systemic administration, aiming to improve survival rates for patients suffering from high-mortality cancers that currently lack effective treatment options.
