- Silexion Therapeutics has entered into a collaboration with Catalent for the formulation development and clinical manufacturing of its siRNA candidate, SIL204.
- The project will be carried out at Catalent’s Limoges facility in France and supports Silexion’s dual-route delivery strategy targeting KRAS-driven cancers.
Silexion Therapeutics Corp., a clinical-stage biotechnology company focused on RNAi therapies, has announced a collaboration with Catalent for the development and manufacturing of SIL204, its next-generation siRNA candidate targeting KRAS-driven cancers.
The agreement will see Catalent undertake formulation development and clinical manufacturing at its facility in Limoges, France. This collaboration will support Silexion’s dual-route strategy for SIL204, aimed at delivering the therapy both systemically and intratumorally to address primary tumours and metastatic spread.
SIL204 has shown promise in preclinical studies, where it significantly reduced tumour growth and metastasis in pancreatic cancer models. The compound targets a range of KRAS mutations, including G12D, G12V, G12R, Q61H, and G13D, which are prevalent in pancreatic, colorectal, and lung cancers.
“This collaboration with Catalent represents a significant advancement in our SIL204 development programme,” said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. He added that the partnership will help optimise SIL204’s formulation in preparation for clinical trials targeted for the first half of 2026.
Catalent’s Limoges site specialises in injectable formulations and will apply its experience with sustained-release technologies to improve SIL204’s stability and delivery precision. The project aligns with Silexion’s broader strategy to move the candidate through preclinical studies, with regulatory submissions planned for 2025 and 2026.
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