Silexion Therapeutics Corp. (NASDAQ: SLXN) has selected AMS Advanced Medical Services GmbH as its contract research organization to support upcoming Phase 2/3 clinical trials for SIL204, the company's next-generation siRNA candidate targeting KRAS-driven solid tumor cancers. The partnership represents a critical milestone as the clinical-stage biotechnology company advances its RNA interference therapy toward pivotal trials.
Strategic Partnership for Clinical Development
AMS brings over 28 years of drug development experience and proven Phase 3 oncology trial expertise to support Silexion's clinical program. The collaboration is expected to encompass regulatory strategy, clinical trial design, site selection and management, and data analysis for the planned Phase 2/3 study.
"Selecting AMS as our CRO partner represents a critical milestone as we advance SIL204 toward clinical development," said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. "This partnership brings the deep oncology expertise and regulatory knowledge essential for executing our dual-route administration strategy effectively."
Dr. Christian Carls, Managing Director of AMS, emphasized the significance of the collaboration: "AMS provides Silexion a global CRO with extensive experience across a wide range of oncology indications and particularly deep expertise in pancreatic cancer. Partnering with Silexion provides a rare and meaningful opportunity to contribute to the development of an important and potentially disease-altering treatment."
Regulatory Timeline and Trial Design
The partnership is expected to 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 upcoming Phase 2/3 trial is planned to evaluate SIL204's innovative dual-route administration strategy in patients with locally advanced pancreatic cancer. This approach integrates both intratumoral delivery to target primary tumors and systemic administration to address metastatic disease, 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.
Groundbreaking Preclinical Results
The CRO selection follows a series of groundbreaking preclinical results announced in recent months, demonstrating SIL204's efficacy across multiple cancer types. Notable findings include 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.
Overall, SIL204 has shown activity against multiple KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D. These results support the therapeutic potential of the siRNA candidate in addressing KRAS-driven cancers, which are generally considered to involve the most common oncogenic gene driver in human cancers.
Company Background and Development Strategy
Silexion Therapeutics is a clinical-stage biotechnology company pioneering RNA interference therapies for KRAS-driven cancers. The company previously conducted a Phase 2a clinical trial in its first-generation product, which showed a positive trend in comparison to the control of chemotherapy alone.
With SIL204 having demonstrated significant preclinical efficacy and a manufacturing partnership with Catalent already in place, Silexion is building a comprehensive foundation to advance this potentially transformative RNAi therapy to patients with KRAS-driven cancers. The company expects to finalize the partnership agreement with AMS shortly following the CRO selection.
