- Silexion Therapeutics (SLXN, Financial) collaborates with Catalent for SIL204 formulation and clinical manufacturing.
- SIL204 aims at multiple KRAS mutations, showing efficacy in preclinical pancreatic cancer models.
- Human clinical trials planned for early 2026, with regulatory submissions preceding in 2025.
Silexion Therapeutics (SLXN), a clinical-stage biotechnology company, has entered a strategic collaboration with Catalent to develop the formulation and enhance clinical manufacturing capabilities for SIL204, its next-generation siRNA candidate. The partnership leverages Catalent's advanced delivery technologies at their Limoges facility in France, focusing on optimizing both systemic and intratumoral delivery formulations.
The collaboration builds on promising preclinical results, wherein SIL204 showed significant efficacy in reducing primary tumor growth and metastatic spread in pancreatic cancer models. SIL204 targets several KRAS mutations—G12D, G12V, G12R, Q61H, and G13D—critical in pancreatic, colorectal, and lung cancers.
Looking ahead, Silexion plans to begin human clinical trials in the first half of 2026. Prior to this, the company aims to submit regulatory applications to the Israel Ministry of Health in the second half of 2025, followed by submissions to the European Union in the first half of 2026. Throughout 2025, Silexion will conduct additional toxicology and pharmacodynamic studies as part of their comprehensive development strategy.
