Silexion Therapeutics Selects Contract Research Organization for Phase 2/3 Clinical Trials of SIL204

Silexion Therapeutics has selected a contract research organization (CRO) to support its upcoming Phase 2/3 clinical trials for SIL204. The CRO, AMS Advanced Medical Services GmbH, brings over 28 years of drug development experience and proven Phase 3 oncology trial expertise. The partnership is expected to support regulatory submissions to the Israel Ministry of Health in Q4 2025 and the European Union in Q1 2026, with Phase 2/3 clinical trials commencing in H1 2026. SIL204 recently demonstrated up to 97% inhibition rates in preclinical studies.

Silexion Therapeutics Corp. (NASDAQ: SLXN) has selected AMS Advanced Medical Services GmbH (AMS) as its contract research organization (CRO) to support its upcoming Phase 2/3 clinical trials for SIL204. The partnership is a strategic milestone for the company as it advances its next-generation siRNA candidate targeting KRAS-driven solid tumor cancers.

AMS, with over 28 years of drug development experience and proven expertise in Phase 3 oncology trials, will support Silexion's planned regulatory submissions to the Israel Ministry of Health in the fourth quarter of 2025 and to the European Union in the first quarter of 2026. Phase 2/3 clinical trials are expected to commence in the first half of 2026.

The selection of AMS follows a series of groundbreaking preclinical results, including SIL204's demonstrated efficacy across pancreatic, colorectal, and lung cancer models. Notably, SIL204 showed up to 97% inhibition in pancreatic cancer cells with KRAS Q61H mutations, approximately 90% inhibition in colorectal cancer cells, and significant dose-dependent activity in lung cancer cell lines. These results highlight SIL204's potential to target multiple KRAS mutations.

The upcoming Phase 2/3 trial will evaluate SIL204's innovative dual-route administration strategy, which integrates both intratumoral delivery to target primary tumors and systemic administration to address metastatic disease. This approach is supported by preclinical data demonstrating SIL204's ability to significantly reduce both primary tumor growth and metastatic spread in clinically relevant orthotopic pancreatic cancer models.

The partnership with AMS is expected to encompass regulatory strategy, clinical trial design, site selection and management, and data analysis. The collaboration aims to bring the highest standards of operational excellence, scientific rigor, and patient focus to this critical program.

Silexion expects to finalize the partnership agreement with AMS shortly following this selection. The company's manufacturing partnership with Catalent is already in place, further bolstering the foundation for SIL204's clinical development.

References:
[1] https://www.globenewswire.com/news-release/2025/09/04/3144642/0/en/Silexion-Therapeutics-Announces-Selection-of-Contract-Research-Organization-to-Support-Upcoming-Phase-2-3-Clinical-Trials-for-SIL204.html
[2] https://www.stocktitan.net/news/SLXN/silexion-therapeutics-announces-selection-of-contract-research-mlua0gwicgxv.html