AGT103-T Shows Promising Results in HIV Treatment at IAS 2025

American Gene Technologies (AGT), a clinical-stage biotechnology firm based in Rockville, Maryland, has unveiled promising results from its innovative HIV treatment, AGT103-T, during a late-breaker oral presentation at the 13th International AIDS Society Conference on HIV Science (IAS 2025) held in Kigali, Rwanda. The presentation, delivered on July 22, 2025, highlighted significant findings from a Phase 1 trial that evaluated the efficacy of AGT103-T, a cell and gene therapy aimed at enhancing and protecting HIV-specific immune cells.

In the trial involving five evaluable patients, all subjects exhibited a notable reduction in Intact Proviral HIV DNA (IPDA) following treatment with AGT103-T. Most remarkably, one participant's HIV reservoir diminished from approximately 1,664 copies per million CD4+ T cells to undetectable levels by Day 500 of treatment, maintaining this suppression for over two years. The data was generated using a novel modified IPDA capable of differentiating between vector and viral sequences.

"These data provide early evidence that AGT103-T may directly reduce the replication-competent HIV reservoir, a crucial step toward achieving a functional cure," stated Jeff Galvin, CEO of American Gene Technologies, during the presentation. He emphasized that the results support the potential of genetically modified autologous T cell therapy to revolutionize HIV treatment paradigms.

The findings presented not only mark a significant milestone in AGT's mission to offer a durable immune-based solution to HIV but also reinforce the platform's first-in-class status targeting latent reservoirs, a key challenge in achieving viral eradication or long-term remission without the need for continuous antiretroviral therapy.

Dr. Wm David Hardy, a member of AGT's Scientific Advisory Board and a veteran HIV researcher, commented, "While still preliminary, these clinical outcomes are promising signs that an HIV cure is within reach. The ability to establish viral control and deplete the intact proviral reservoir holds exciting promise for the field."

The company plans to initiate further trials in 2026 to substantiate these findings with a larger cohort and to refine strategies for analytical treatment interruptions (ATI). AGT is also exploring strategic partnerships aimed at accelerating development and broadening access to this novel therapeutic.

AGT103-T represents a significant advancement in HIV treatment methodologies, utilizing an autologous T cell therapy approach that genetically modifies a patient's own cells to resist HIV infection and enhance immune control. The treatment is administered as a single infusion, with ongoing evaluations to assess its effectiveness in reducing or eliminating the need for lifelong antiretroviral therapy.

In conclusion, the preliminary results from AGT103-T signify a transformative potential in the fight against HIV, reflecting a growing optimism within the scientific community regarding the possibility of a functional cure. As AGT progresses with its clinical trials, the implications for patients and the broader healthcare landscape could be profound, marking a pivotal moment in HIV treatment history.