Argos Therapeutics Inc.’s experimental HIV immunotherapy failed its mid-stage trial.
The company announced today that its investigational fully personalized immunotherapy, AGS-004, failed to meet the primary endpoint in its Phase 2b clinical trial, evaluating the drug in patients chronically infected with HIV-1. According to top-line results, AGS-004 did not meet the primary endpoint, which required a 1.1 Log lower median viral load (VL) after 12 weeks of interruption of antiretroviral therapy (ATI) in the treatment group versus the placebo group. Although the drug failed the trial, Argos said the test results were promising and warranted continued development of the drug.
The company highlighted the fact that the trial provided evidence of AGS-004’s ability to induce memory T-cell responses, which could have directly impacted the latent viral reservoir. Among patients who received AGS-004 and completed ATI, 70 percent had positive antiviral memory T-cell responses prior to ATI compared to zero percent of placebo patients. Additionally, patients receiving AGS-004 that had antiviral memory T-cell responses had significantly fewer CD4+ T-cells with integrated HIV DNA compared to non-responders.
“These data support our plans to continue testing AGS-004 in the studies aimed at decreasing or eliminating the latent HIV reservoir. In addition, based on these data we believe that more frequent dosing of AGS-004 during ART may provide further benefit, but also highlight the need to better understand the mechanisms of immune evasion employed by the HIV virus in the absence of ART,” said Dr. Charles Nicolette, chief scientific officer and president of R&D of Argos.
“These results of the AGS-004 Phase 2b trial allow us to now ask if combining AGS-004 treatment with HDAC inhibitors, part of a new class of latent reservoir mobilizers, will lead to the elimination of HIV-infected cells,” said Dr. David Margolis of the University of North Carolina, principal investigator of the AGS-004 Phase 2a adult eradication study. “We look forward to initiating stage two of the adult eradication study where patients on ART will receive the HDAC inhibitor vorinostat in addition to AGS-004.”
Source: Argos Therapeutics Inc.