Core Insights - Silexion Therapeutics has made significant progress in 2025, positioning its lead asset SIL204 for human clinical trials in the first half of 2026, targeting KRAS-driven cancers [2][9] - The company aims to address a global market exceeding $30 billion for KRAS-driven cancer treatments, particularly focusing on pancreatic, colorectal, and lung cancers [4][3] Company Developments - In 2025, Silexion demonstrated exceptional preclinical efficacy of SIL204, achieving over 90% inhibition of cancer cell growth across multiple human cancer cell line models [5][6] - The company validated SIL204's activity against eight distinct KRAS mutations, including G12D, G12V, and G12C, and showed efficacy in five cancer types [5][6] - Silexion completed toxicology studies confirming no systemic organ toxicity and received positive feedback from Germany's BfArM on its Phase 2/3 trial design [7][8] Clinical Trial Plans - The initiation of the Phase 2/3 clinical trial for SIL204 in locally advanced pancreatic cancer (LAPC) is planned for the first half of 2026, with regulatory submissions already completed in Israel [9][10] - The trial will utilize a dual-route strategy combining intratumoral delivery and systemic administration, with an initial safety run-in involving approximately 18 patients [10][11] Market Context - The KRAS inhibitor market is projected to reach approximately $10 billion by 2032, yet current therapies are mutation-specific and do not address the majority of KRAS-driven cancers [3] - Over 80% of pancreatic cancer mortality is attributed to metastatic disease, highlighting the unmet need that SIL204 aims to address [4]
Silexion Therapeutics Releases CEO Letter to Shareholders Highlighting 2025’s Significant Achievements and Outlining Upcoming Milestones for 2026