On June 23, 2026 Silexion Therapeutics Corp. (NASDAQ: SLXN) ("Silexion" or the "Company"), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, reported that it has received formal approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM, Bundesinstitut für Arzneimittel und Medizinprodukte) to initiate its planned Phase 2/3 clinical trial of SIL204, the Company’s lead small interfering RNA (siRNA) product candidate, in patients with locally advanced pancreatic cancer (LAPC). The trial has been approved without conditions, with both Part I and Part II of the assessment determined to be justifiable, following the positive opinion of the Ethics Committee of the North Rhine Medical Association regarding the conduct of the trial in Germany.
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The decision was issued under Articles 5 and 8 of EU Regulation No. 536/2014 in conjunction with the German Medicines Act (AMG), with Germany serving as the Reporting Member State (rMS) leading the scientific assessment of the trial under the EU Clinical Trials Regulation. The approval follows the Company’s April 2026 submission of its Clinical Trial Application (CTA) through the EU Clinical Trials Information System (CTIS), which was informed by the positive written Scientific Advice from BfArM received in December 2025, the previously announced completion of two-species toxicology studies confirming no systemic organ toxicity, and the Company’s broader preclinical package. The decision also builds on the March 24, 2026 approval from the Israeli Ministry of Health, which authorized initiation of the same Phase 2/3 trial in Israel. With the assessment in Germany complete, Silexion is now positioned to potentially expand its Phase 2/3 program across additional EU member states under the harmonized CTIS framework.
"With this BfArM approval, Silexion has now secured clinical trial authorizations in the two leading regulatory jurisdictions where we sought to initiate the Phase 2/3 trial of SIL204," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics. "Germany is widely regarded as one of the most rigorous regulatory environments globally, and an unconditional approval as Reporting Member State under the EU Clinical Trials Regulation is, for us, a strong external validation of the SIL204 preclinical and safety package and a meaningful endorsement of the trial design we developed in close engagement with the agency. With Israeli and German authorizations now in hand, our focus shifts entirely to clinical execution, and we expect to dose our first patient in the coming weeks at one of the activated sites in Israel or Germany."
With both regulatory authorizations now obtained, Silexion is finalizing site activation procedures at participating medical centers in Israel and Germany, including the contracting and budget arrangements customary for multi-site international trials of this scale. The Company expects first-patient dosing to occur in the coming weeks, with the initial dosing site to be determined by the timing of site activation across the participating centers. Site activation in Israel is led by Sheba Medical Center and Tel Aviv Sourasky Medical Center, both of which previously received local ethics approvals for the trial, with leading German oncology centers being brought into the program under the EU CTIS framework.
The Phase 2/3 trial is designed to evaluate SIL204 in combination with standard-of-care chemotherapy in patients with LAPC, using Silexion’s innovative dual-route administration strategy – combining intratumoral delivery to target primary tumors with systemic administration to address metastatic disease. The study is structured as an initial safety run-in cohort of approximately 18 patients, followed by expansion into a randomized cohort of approximately 166 patients. Pancreatic cancer remains one of the most lethal malignancies, with a five-year survival rate below 13%, and more than 80% of pancreatic cancer mortality driven by metastatic disease. KRAS mutations are present in approximately 90% of pancreatic cancers, 45% of colorectal cancers, and 30–35% of lung adenocarcinomas, representing one of the largest and most persistent unmet needs in oncology.
(Press release, Silexion Therapeutics, JUN 23, 2026, View Source [SID1234668925])