Silexion Therapeutics (SLXN, Financial) has entered into a strategic partnership with Catalent (CTLT) to advance the development of SIL204, its innovative siRNA candidate. The collaboration will see Catalent undertake formulation development and clinical manufacturing activities at its Limoges, France facility, a hub for clinical biologics formulation and complex injectable manufacturing.
The focus of this partnership is on refining both systemic and intratumoral delivery mechanisms for SIL204, aligning with Silexion’s dual-route development approach aimed at targeting primary tumors and metastatic lesions in KRAS-driven cancers. Catalent's expertise in sustained-release technologies is expected to enhance SIL204's therapeutic impact by improving its stability, bioavailability, and delivery accuracy.
Silexion's strategy involves advancing SIL204 through preclinical stages into clinical trials. The plan includes additional toxicology and pharmacodynamic studies throughout 2025, with potential regulatory filings anticipated with the Israeli Ministry of Health in late 2025 and the European Union in early 2026.