At a Glance
- First participant dosed in Phase 1 trial of JANX011 for autoimmune diseases
- CD19-targeted bispecific immunotherapy developed using proprietary ARM platform
- Designed to enable deep and durable B-cell depletion without preconditioning
- Preclinical data suggest broad safety window and low cytokine release risk
Written By: Katherashala Dharan Kumar Pharm D
Reviewed By: Pharmacally Editorial Team
Janux Therapeutics, Inc. a clinical-stage biopharmaceutical company, announced the dosing of the first participant in a Phase 1 clinical study of JANX011 (NCT07291323). This CD19-targeted bispecific immunotherapy developed using the company’s proprietary Adaptive Immune Response Modulator (ARM) platform, targets autoimmune diseases by enabling deep and durable depletion of CD19-expressing B cells in blood and tissue.
JANX011 represents the first clinical candidate from the ARM platform, which is engineered to mimic an adaptive immune response. Unlike traditional T-cell engagers that require repeated dosing for sustained B-cell depletion, ARM molecules promote controlled T-cell expansion only while target cells persist, followed by contraction post-elimination. This design aims for tissue-level clearance without lymphodepletion or pre-conditioning.
Preclinical studies demonstrated that a single subcutaneous dose of JANX011 achieved profound B-cell depletion across blood and tissue, with prolonged memory B-cell reset. Notably, cytokine levels stayed low over a >100-fold dose range, suggesting a wide safety margin and lower cytokine release syndrome risk compared to conventional therapies.
“Dosing the first participant with JANX011 marks an important milestone for Janux and our ARM platform’s first clinical evaluation,” said David Campbell, Ph.D., President and CEO. “JANX011 targets autoimmune diseases initially, with potential broader applications in CD19-expressing conditions like hematologic malignancies.”
The open-label, dose-escalation trial in healthy adult volunteers will assess safety, tolerability, pharmacokinetics, and pharmacodynamics, including B-cell depletion, memory B-cell reset, T-cell expansion, and cytokine dynamics. Early data will guide dose selection and autoimmune indication prioritization.
“Preclinical data suggest JANX011 could match CAR-T pharmacodynamics stable immune changes and autoantibody reduction while providing autoimmune patients with better safety, convenience, and re-dosing flexibility,” said Tommy DiRaimondo, Ph.D., Chief Scientific Officer and Co-founder.
This trial advances Janux’s pipeline of novel immunotherapies, potentially transforming treatment for B-cell mediated autoimmune conditions.
References
Janux Therapeutics. Janux Therapeutics Announces First Patient Dosed in Phase 1 Study of JANX011, February 17, 2026, Janux – Investor Relations – Janux Therapeutics Announces First Patient Dosed in Phase 1 Study of JANX011
Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability, ClinicalTrials.gov ID NCT07291323, https://clinicaltrials.gov/study/NCT07291323