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JANX011 is a masked, bispecific T-cell engager (TCE) developed by Janux Therapeutics for the treatment of autoimmune diseases. Utilizing Janux's proprietary TRACT (Tumor Activated T Cell Engager) platform technology, JANX011 is designed as a prodrug that remains inactive in systemic circulation due to a masking moiety that sterically hinders the CD3 binding site. Upon reaching sites of inflammation where specific proteases are upregulated, the mask is cleaved, allowing the molecule to simultaneously bind CD19 on B cells and CD3 on T cells. This redirection of T-cell cytotoxicity leads to the targeted depletion of pathogenic B cells. By restricting activity to specific environments, JANX011 aims to provide a wider therapeutic window and reduced systemic toxicities, such as cytokine release syndrome (CRS), compared to conventional non-masked T-cell engagers. It is currently being evaluated in a Phase 1 first-in-human study in healthy adult volunteers to assess safety, pharmacokinetics, and pharmacodynamics.
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