Drug intelligence / Profile preview

DAX-044

Development stage
Preclinical
Lead developer
Audax Biosciences
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes
01

Overview

DAX-044 is an investigational, immune-targeted interleukin-12 (IL-12) antibody-cytokine fusion (immunocytokine) designed using Audax Biosciences' proprietary AVIKINE platform. It is engineered to selectively concentrate IL-12's immune-activating activity within the tumor microenvironment (TME) while minimizing systemic exposure and toxicity, which has historically limited the clinical utility of IL-12 therapies. Preclinical studies suggest a potentially best-in-class therapeutic index for DAX-044. In October 2026, Astellas Pharma and Audax Biosciences entered into an exclusive option and license agreement for the global development, manufacturing, and commercialization of DAX-044, with Audax retaining co-funding and co-promotion rights in Australia and New Zealand. The candidate is currently in IND/CTN-enabling development, with a Phase 1 clinical trial expected to commence in 2027 for the treatment of solid tumors.

02

Targets

IL-12R (Interleukin-12 receptor)

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