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Janux Therapeutics Announces Positive Initial Phase 1 Data for JANX011 in Healthy Volunteers, Supporting Planned Development in Patients with Autoimmune Disease

JANX
  • A single 3 mg subcutaneous dose of JANX011 produced greater than 90% peripheral B-cell depletion in most participants, including two with B cells below the limit of detection, with reductions persisting through Day 42
  • All observed cytokine release syndrome events were Grade 1, with no serious adverse events or dose-limiting toxicities reported across 25 healthy volunteers
  • Dose-responsive activation was concentrated in the intended TRBV6-expressing T-cell subset, linking selective T-cell recruitment with deep B-cell depletion
  • Janux plans to advance JANX011 into autoimmune patient studies for immune thrombocytopenia in the first half of 2027, followed by rheumatoid arthritis studies in the second half of 2027
  • Janux hosted an investor webcast on November 9, 2026, to review initial JANX011 clinical data, followed by a live Q&A session
  • JANX011 is the first clinical-stage candidate from Janux's proprietary Adaptive Immune Response Modulator (ARM) platform, designed to selectively recruit defined T-cell subsets via the TRBV6 domain
  • The Phase 1 study in healthy volunteers evaluated safety, tolerability, pharmacokinetics, & pharmacodynamics across five single-ascending-dose cohorts ranging from 30 µg to 3 mg
  • At 3 mg, one Grade 3 ALT elevation & Grade 2 ALT/AST elevations were observed but were transient, asymptomatic, & did not require treatment
  • JANX011 is an investigational CD19-targeted bispecific T-cell engager intended for the potential treatment of autoimmune diseases
  • Janux aims to use ITP & RA indications to establish clinical proof of concept & characterize JANX011's clinical profile regarding dose, regimen, durability, & activity