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Janux Therapeutics Announces First Patient Dosed in Phase 1 Study of JANX011

  • Janux Therapeutics has dosed the first participant in a Phase 1 clinical study for JANX011, a CD19-targeted bispecific engineered using the proprietary Adaptive Immune Response Modulator (ARM) platform.
  • JANX011 is being developed for autoimmune diseases to enable deep, durable immune reset through targeted depletion of CD19-expressing B cells in blood & tissue.
  • The ARM platform differs from conventional T-cell engagers by driving controlled T-cell expansion while target cells are present, followed by contraction after elimination, which aims to clear target cells without lymphodepletion or pre-conditioning.
  • Preclinical studies showed a single subcutaneous dose of JANX011 achieved deep B-cell depletion in blood & tissue with prolonged memory B-cell reset while maintaining low cytokine levels across a >100-fold dose range.
  • The Phase 1 trial (NCT07291323) is an open-label, dose-escalation study in healthy adult volunteers designed to evaluate safety, tolerability, pharmacokinetics, & pharmacodynamics.
  • The study aims to characterize B-cell depletion, memory B-cell reset, T-cell expansion, & cytokine release risk to inform dose selection & prioritization of autoimmune indications.
  • Janux also has other clinical candidates in development, including JANX007 (PSMA-targeted TRACTr for mCRPC) & JANX008 (EGFR-targeted TRACTr for solid tumors).