Phase 2a study of AGS-004 for the immunotherapeutic treatment of HIV infection

Argos Therapeutics announced positive data from an ongoing Phase 2a trial of AGS-004, a personalized, RNA-loaded, dendritic cell-based immunotherapy for the treatment of HIV infection. AGS-004 utilizes the company’s proprietary Arcelis technology to be perfectly matched to each patient’s unique HIV viral burden. Patients enrolled in the trial had pre-antiretroviral (ART) viral load levels ranging between 10,000–500,000copies/mL.

Data were presented for 16 patients that had successfully completed the structured treatment interruption (STI). After the three month treatment break from ART, 13 of 16 patients had a lower viral load compared to their pre-ART levels, with a mean reduction >1 Log, corresponding to a >80% reduction from pre-ART levels. AGS-004 also exhibited a favorable side-effect and safety profile, with no reports of autoimmunity or AIDS-defining events during the STI, and no treatment-related serious adverse events reported.

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