Drug intelligence / Profile preview

JANX011

Development stage
Phase 1
Lead developer
Janux Therapeutics
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, T-cell Engagers → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Subcutaneous, Intravenous
01

Overview

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.

02

Targets

CD19 (B lymphocyte antigen CD19)CD3 (T-cell surface glycoprotein CD3)

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