Silexion Therapeutics has entered into a collaboration with Catalent to support formulation development and clinical manufacturing of SIL204, its investigational RNAi therapy targeting KRAS-driven cancers.
The work will take place at Catalent’s facility in Limoges, France, and will focus on optimizing both systemic and intratumoral delivery of the siRNA candidate.
SIL204 is designed to target a broad range of KRAS mutations, common drivers in pancreatic, colorectal, and lung cancers. The agreement follows Silexion’s recent preclinical data showing SIL204 reduced tumor growth and metastasis in pancreatic cancer models, as the company prepares for further development and clinical testing.
The collaboration includes plans for additional toxicology and pharmacodynamic studies throughout 2025. Silexion aims to submit regulatory applications to Israel’s Ministry of Health by the end of the year, with a European Union submission expected in early 2026.
Silexion Therapeutics is a clinical-stage biotechnology company specializing in RNAi therapies aimed at treating solid tumors driven by KRAS mutations, particularly in pancreatic cancer.
Catalent’s Limoges site specializes in complex injectable formulations and sustained-release technologies. The company’s expertise will support Silexion’s strategy to begin clinical trials of SIL204 in the first half of 2026.