Grand Cayman, Cayman Islands — January 6, 2026 — Leads & Copy — Silexion Therapeutics Corp (NASDAQ: SLXN) announced that SIL204 demonstrated significant tumor inhibition in positive pre-clinical studies with activity across pancreatic, colorectal, and lung cancer models. The company’s platform seeks to address an estimated $30+ billion global KRAS-driven cancer market with a Pan-KRAS therapeutic platform. Following positive regulatory feedback and successful toxicology studies, the initiation of a Phase 2/3 clinical trial in LAPC is planned for H1 2026.
Silexion Therapeutics Corp (NASDAQ: SLXN), a clinical-stage biotechnology company pioneering RNA interference (RNAi) therapies for KRAS-driven cancers, today released a letter to shareholders from Chairman and Chief Executive Officer, Mr. Ilan Hadar. The letter outlines the Company’s major progress in 2025, including positive preclinical data demonstrating significant inhibition in human KRAS-mutated cancer cell line models, successful completion of regulatory toxicology studies, positive feedback from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) on Phase 2/3 trial design, and strategic manufacturing and clinical development collaborations positioning SIL204 for its planned human clinical trial initiation in 2026. In parallel, the letter outlines the vision ahead for 2026 and significant expected near-term milestones.
According to industry estimates, the KRAS inhibitor market is projected to reach approximately $10 billion by 2032, yet the only KRAS-targeted therapies currently approved are mutation-specific, addressing a limited subset of KRAS alterations, and the majority of KRAS-driven cancers still lack effective targeted treatment options.
Throughout 2025, the company generated compelling preclinical evidence demonstrating SIL204’s exceptional potency and broad applicability. The pre-clinical results showed significant inhibition of cancer cell growth in human cancer cell line models, which consistently exceeded 90% across multiple models. Activity was validated against eight distinct KRAS mutations, including G12D, G12V, G12R, G12C, G13C, G12A, Q61H, and G13D.
Preclinical efficacy was demonstrated across five different cancer types, including pancreatic, colorectal, lung, gastric, and additional solid tumor models. In clinically relevant orthotopic pancreatic cancer models, SIL204 demonstrated significant reduction of both primary tumor growth and metastatic spread to secondary organs following systemic administration. The company confirmed drug distribution to major metastatic sites, including liver, peritoneum, and lung, with measurable reductions in tumor burden at clinically relevant doses.
The company completed two-species toxicology studies confirming no systemic organ toxicity, received positive written Scientific Advice from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) on their Phase 2/3 trial design, established strategic collaborations with Catalent for clinical manufacturing and AMS Advanced Medical Services as their contract research organization, and raised over $18 million in aggregate financing during 2025 while regaining full Nasdaq compliance.
The company has completed regulatory submissions in Israel to initiate the Phase 2/3 clinical trial of SIL204 in locally advanced pancreatic cancer (LAPC). A response is anticipated during the first quarter of 2026, with clinical trial commencement planned for the first half of 2026.
Additional regulatory submissions to Germany are planned for the first quarter of 2026, with additional European Union submissions expected later in 2026 and a U.S. IND submission anticipated in the second half of 2026. The innovative dual-route strategy combines intratumoral delivery for primary tumors with systemic administration for metastases. The initial safety run-in will evaluate this approach in combination with standard chemotherapy in approximately 18 patients, assessing safety, tolerability, and preliminary efficacy signals. Following successful completion, the company plans to expand into a second stage of the phase 2/3 clinical trial which would include a randomized study of approximately 166 patients.
Silexion Therapeutics is dedicated to the development of innovative treatments for unsatisfactorily treated solid tumor cancers which have the mutated KRAS oncogene. Silexion is committed to pushing the boundaries of therapeutic advancements in the field of oncology, and further developing its lead product candidate for locally advanced pancreatic cancer.
Company Contact:
Silexion Therapeutics Corp
Ms. Mirit Horenshtein Hadar, CFO
mirit@silexion.com
Investor Contact:
Arx Investor Relations
North American Equities Desk
silexion@arxhq.com
Source: Silexion Therapeutics
