Significant regulatory milestone marks advancement into clinical-stage development of next-generation RNAi therapy featuring an innovative, integrated systemic treatment delivery approach targeting highly prevalent KRAS-driven cancers with significant unmet medical need
Company reported strong positive preclinical study results demonstrating significant anti-tumor activity in multiple models and announced successful completion of toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design
Silexion expects to initiate human clinical trials in the second quarter of 2026
Grand Cayman, Cayman Islands, March 24, 2026 (GLOBE NEWSWIRE) -- Silexion Therapeutics Corp. (NASDAQ:SLXN) ("Silexion" or the "Company"), a clinical-stage, oncology-focused biotechnology company, today announced that it has received formal approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial evaluating SIL204 for the treatment of locally advanced pancreatic cancer, following positive preclinical results that demonstrated significant anti-tumor activity in mulitple models alongside successful completion of toxicology studies.
This approval represents a major regulatory milestone and a critical advancement for the Company, enabling the transition of SIL204 into human clinical evaluation and positioning Silexion as a clinical-stage biotechnology company focused on KRAS-driven cancers.
SIL204 is designed to silence KRAS mutations, which are present in over 90% of pancreatic cancers and are widely recognized as one of the most challenging targets in oncology. Unlike mutation-specific approaches, SIL204 is engineered to target a broad range of KRAS mutations, supporting its potential applicability across multiple high-value cancer indications.
The approval follows a series of major positive developments achieved by the Company, including strong positive anti-tumor activity demonstrated in multiple preclinical models, successful completion of toxicology studies, and constructive regulatory engagement supporting the Phase 2/3 trial design. Together, these achievements have enabled SIL204 to advance toward clinical-stage development. The Company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of this current quarter, with additional regulatory filings across the European Union planned in early 2027.