Silexion Therapeutics Corp. (SLXN) on Wednesday announced a strategic collaboration with Catalent Inc., a global contract development and manufacturing organization, for its SIL204 development program.
SIL204 is a next-generation siRNA candidate targeting KRAS-driven cancers. In preclinical trials, a single administration of SIL-204 encapsulated in an extended-release formulation yielded tumor necrosis in pancreatic cancer models. Preclinical studies for SIL-204 in colorectal cancer models are also set to begin.
The company plans to initiate human clinical trials of SIL204 in the first half of 2026.
As per the agreement terms, Catalent will conduct formulation development and clinical manufacturing activities for Silexion's SIL204 at its state-of-the-art facility in Limoges, France. The collaboration will focus on optimizing both systemic and intratumoral delivery formulations, supporting Silexion's dual-route strategy aimed at treating both primary tumors and metastases in pancreatic, colorectal, and lung cancers.
"We are excited to work with Catalent, whose expertise in sustained-release and complex injectable technologies will be critical as we move SIL204 toward first-in-human trials," said Ilan Hadar, Chairman and Chief Executive Officer of Silexion Therapeutics.
The company expects to complete toxicology and pharmacodynamic studies of SIL204 in 2025, followed by regulatory submissions to the Israel Ministry of Health in late 2025 and the European Union in early 2026.
Currently, SLXN is trading at $1.06 up by 46.73 percent on the Nasdaq.
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