Janux Therapeutics has dosed the first participant in a Phase I clinical trial of JANX011, a Cluster of Differentiation 19 (CD19)-targeted bispecific candidate designed using its adaptive immune response modulator (ARM) platform.
The open-label, dose-escalation trial will assess the tolerability, safety, pharmacodynamics, and pharmacokinetics of JANX011 in healthy adults.
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The investigation aims to define key immune responses, such as memory B-cell reset, B-cell depletion, cytokine release risk, and T-cell expansion.
The trial is expected to provide early pharmacodynamic data that will inform dose selection and indicate which autoimmune conditions should be prioritised in subsequent development stages.
JANX011 is intended for autoimmune disease treatment through targeted depletion of CD19-expressing B cells in both blood and tissues to achieve a deep and lasting immune reset.
It represents the first clinical candidate from Janux’s ARM platform, which seeks to enable enduring B-cell depletion by leveraging adaptive-like immune responses while improving the safety profile and convenience of immune-engaging therapies.
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By GlobalDataJanux Therapeutics president and CEO David Campbell said: “Dosing the first participant with JANX011 marks an important milestone for Janux and the first clinical evaluation of our ARM platform.
“While JANX011 is initially being developed for autoimmune diseases, the differentiated immune profile of the ARM platform may also have broader implications across CD19-expressing diseases, including haematologic malignancies.”
Janux Therapeutics chief scientific officer and co-founder Tommy DiRaimondo said: “Based on compelling preclinical data, we believe JANX011 has the potential to achieve pharmacodynamic effects comparable to those seen with CAR-T therapies, including stable immune cell population changes and reductions in autoantibody drivers of disease, while offering the safety, convenience, and re-dosing flexibility required for autoimmune patients.”
In May 2025, Janux started Phase Ib expansion trials with JANX007 in the first-in-human ENGAGER-PSMA-01 clinical trial, aimed at treating advanced metastatic castration-resistant prostate cancer (mCRPC).
