Janux Therapeutics Reports Initial Phase 1 JANX011 Data, Providing Clinical Validation For ARM Platform In Autoimmune Diseases
Benzinga Newsdesk 4 hours ago
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A single 3 mg subcutaneous dose produced greater than 90% peripheral B-cell depletion in most participants, including two participants with B cells below the limit of detection, with B-cell reductions persisting through
- A single 3 mg subcutaneous dose produced greater than 90% peripheral B-cell depletion in most participants, including two participants with B cells below the limit of detection, with B-cell reductions persisting through Day 42
- All observed cytokine release syndrome events were Grade 1, including in the two participants with B cells below the limit of detection; no serious adverse events or dose-limiting toxicities were 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 and supporting the ARM design
- Janux plans to advance JANX011 into autoimmune patient studies, initially prioritizing immune thrombocytopenia and rheumatoid arthritis, with study initiations targeted for the first and second halves of 2027, respectively
- Janux will host an investor webcast today, November 9, 2026, at 8:30 a.m. ET to review the initial JANX011 clinical data, followed by a live Q&A session
Janux Therapeutics, Inc. (NASDAQ:JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, today announced initial clinical results from the Phase 1 study of JANX011 in healthy volunteers and outlined its planned clinical development strategy in autoimmune diseases. JANX011 is the first program from Janux’s proprietary Adaptive Immune Response Modulator (ARM) platform to enter clinical development. The ARM platform is designed to selectively recruit a defined T-cell subset to drive deep and sustained target-cell depletion while limiting broad T-cell activation.
Following one subcutaneous dose without step-up dosing, JANX011 demonstrated deep B-cell depletion, Grade 1-only cytokine release syndrome (CRS), and selective activation of the intended TRBV6-expressing T-cell subset. Together, these findings provide initial human clinical validation of ARM and establish a strong foundation for advancing JANX011 in autoimmune disease.