Argos Therapeutics, Inc., a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on the Arcelis® technology platform, today announced that the NIH Division of AIDS (DAIDS) has approved $6.6 million in funding for an investigator-initiated Phase 2a adult eradication study of AGS-004, the company’s investigational fully personalized immunotherapy for HIV.
Eliminating the latent virus reservoir has been shown to be an essential goal in efforts to eradicate HIV. Research has shown that histone deacetylase (HDAC) inhibitors can activate cells that are latently infected with HIV, making them more visible to the immune system. One strategy to achieve HIV eradication is known as the “kick and kill” approach where a latency reversing therapy such as an HDAC inhibitor is combined with an immunotherapy to maximize the immune system’s response to the latent reservoir in an effort to eliminate it.
“Previous study results suggest AGS-004 can induce anti-viral memory T-cell responses that are associated with lower persistent viral reservoirs when administered in combination with standard antiretroviral therapy (ART),” said Dr. Charles Nicolette, Argos’ chief scientific officer and vice president of research and development. “The continued support of DAIDS allows us to move forward with stage two of our adult eradication trial, which has already been cleared for initiation by the FDA. We believe that this is the first human clinical trial to test the highly promising ‘kick and kill’ approach to treatment.”
“With this NIH funding, we can now study whether combining AGS-004 treatment with a latent reservoir mobilizer can lead to the elimination of HIV-infected cells,” stated Dr. David Margolis of the University of North Carolina, principal investigator of the AGS-004 Phase 2a adult eradication study. “In stage two of this study, patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004.”