Under the agreement, Catalent will conduct formulation development and clinical manufacturing activities for Silexion's next-generation siRNA candidate, SIL204, at its state-of-the-art facility in Limoges, France. The collaboration will focus on optimizing both the systemic and intratumoral delivery formulations of SIL204, supporting Silexion's recently announced dual-route development strategy designed to target both primary tumors and metastases in KRAS-driven cancers.
This collaboration builds upon Silexion's recently reported breakthrough preclinical data demonstrating SIL204's significant efficacy in reducing both primary tumor growth and metastatic spread in clinically relevant orthotopic pancreatic cancer models. SIL204 targets a broad spectrum of KRAS mutations (including G12D, G12V, G12R, Q61H, and G13D), which are critical drivers in pancreatic, colorectal, and lung cancers.
"Our collaboration with Catalent represents a significant advancement in our SIL204 development program," said Ilan Hadar, Chairman and CEO of Silexion Therapeutics. "Following our recent promising preclinical results and the unveiling of our expanded development plan, we look forward to this partnership advancing the optimization of SIL204's formulation for both systemic and intratumoral delivery routes. Catalent's expertise in complex formulation development will be instrumental as we work toward our goal of initiating human clinical trials in the first half of 2026."
Catalent's Limoges facility is its European center of excellence for clinical biologics formulation development and drug product manufacturing, specializing in complex injectable formulations. The collaboration will leverage Catalent's extensive experience in developing sustained-release technologies to enhance SIL204's therapeutic potential through improved stability, bioavailability, and delivery precision.
This collaboration is part of Silexion's comprehensive strategy to advance SIL204 through preclinical development and into clinical trials, with plans to conduct additional toxicology and pharmacodynamic studies throughout 2025, followed by potential regulatory submissions to the Israel Ministry of Health in the second half of 2025 and to the European Union in the first half of 2026.
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