Argos Therapeutics today announced two presentations at the AIDS Vaccine 2009 conference, detailing positive viral load, immune response and safety data from an ongoing Phase 2a trial of AGS-004, its personalized immunotherapy candidate. AGS-004 is a product of the Company’s Arcelis™ technology, and is a personalized, RNA-loaded, dendritic cell-based immunotherapy that is perfectly matched to each patient’s unique HIV viral burden. The presentations contained important results, including a favorable safety profile for AGS-004, the ability to induce partial to complete viral load control in the absence of antiretroviral therapy (ART) during a 12-week structured treatment interruption (STI), and a potent and diverse immune response to AGS-004 treatment. These AGS-004 results are unprecedented for an immunotherapeutic candidate in HIV and, if confirmed in an upcoming randomized study, could lead to a new treatment paradigm for HIV.
“The Arcelis approach to immunotherapy has broad potential as a new therapeutic strategy to combat HIV,” said Jean-Pierre Routy, M.D., from McGill University Health Centre in Montreal. “The level of viral load control in response to AGS-004 has been unexpectedly strong compared to what has been reported for other immunotherapies tested in similar patient populations. Additionally, because this approach uses patient-specific HIV antigens, it may overcome the extreme genetic heterogeneity of HIV from patient to patient, which has been one of the reasons for the failure of prior HIV immunotherapies.”
In an oral presentation, Dr. Routy, principal investigator of the ongoing Phase 2a trial, discussed data assessing the safety and impact of AGS-004 in controlling viral load during a 12-week STI from ART. Patients enrolled in the trial had pre-ART viral load levels ranging between 10,000-500,000 copies/mL. Data were presented for 16 patients that had successfully completed the 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 of greater than 1 Log, corresponding to a greater than 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.