Silexion Therapeutics Corp. has announced a significant regulatory milestone with the approval from the Israeli Ministry of Health to initiate its Phase 2/3 clinical trial for SIL204, a novel RNAi therapy targeting KRAS mutations prevalent in pancreatic cancer. This approval follows promising preclinical results demonstrating substantial anti-tumor activity across multiple models and successful completion of toxicology studies. The company aims to commence human clinical trials in the second quarter of 2026, marking a pivotal step in its development of innovative treatments for cancers driven by KRAS mutations, which are notoriously difficult to target. The approval positions Silexion as a key player in the oncology space, focusing on addressing significant unmet medical needs in cancer treatment. The company also plans to submit a Phase 2/3 clinical trial application in Germany by the end of the current quarter, with further regulatory filings anticipated across the European Union in early 2027. This strategic advancement reflects Silexion's commitment to developing transformative therapies for patients suffering from KRAS-driven cancers.

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