SLXN News & Events

Silexion Therapeutics announced the initiation of good manufacturing practice, or GMP, clinical batch manufacturing of SIL204, the company's siRNA therapy targeting mutated KRAS, in support of the planned upcoming Phase 2/3 clinical trial in locally advanced pancreatic cancer. Additionally, the company announced that it has received approval from the Helsinki Ethics Committee of Tel Aviv Sourasky Medical Center for the planned Phase 2/3 trial of SIL204 at its site, a leading Israeli oncology center. The clinical batches currently in production will serve as the investigational medicinal product supply used to treat the first patients to be enrolled in the safety run-in segment of the Phase 2/3 trial. The drug substance for SIL204 was successfully manufactured in 2025 by a specialist global oligonucleotide contract development and manufacturing organization. The drug product, the finished clinical formulation administered to patients, is now being manufactured by Catalent at its facility in Limoges, France.

Silexion Therapeutics announced the recent successful submission of a clinical trial application, or CTA, to Germany for its planned Phase 2/3 clinical trial of its lead, small interfering RNA product candidate, SIL204, in patients with locally advanced pancreatic cancer. The CTA was submitted through the EU Clinical Trials Information System, with Germany serving as the Reporting Member State - the country that will lead the scientific assessment of the trial across the European Union.