American Gene Technologies Announces Promising Results from AGT103-T HIV Functional Cure Program Presented as Late-Breaker at International AIDS Society 2025

All evaluable patients (n=5), demonstrated a significant reduction in Intact Proviral HIV DNA (IPDA) following treatment with AGT103-T

ROCKVILLE, Md., July 22, 2025 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT), a clinical-stage biotechnology company focused on cell and gene therapies for infectious diseases, today announced compelling new data from its HIV cure program, AGT103-T, during a late-breaker oral presentation at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda.

The presentation highlighted human clinical data from AGT’s Phase 1 trial evaluating AGT103-T, a cell and gene therapy designed to protect and enhance HIV-specific immune cells. Using a novel, modified Intact Proviral HIV DNA Assay (IPDA) capable of distinguishing vector from viral sequences, AGT reported sustained reductions in intact HIV proviral DNA in all evaluable subjects.

“These data provide early evidence that AGT103-T may directly reduce the replication-competent HIV reservoir, a crucial step toward achieving a functional cure,” said Jeff Galvin, CEO of American Gene Technologies. “The results support our belief that genetically modified autologous T cell therapy has the potential to transform HIV treatment paradigms.”

Key Findings Presented:

• In all five evaluable participants, AGT103-T resulted in a significant decrease in intact HIV proviral DNA in blood.
• One subject’s reservoir dropped from ~1,664 copies per million CD4+ T cells to undetectable levels by Day 500, with suppression sustained for over two years.
• Defective proviral DNA remained stable, underscoring the selective impact of AGT103-T on the replication-competent reservoir.
• Analytical treatment interruptions (ATI) provided additional insight into the immune system’s ability to control viral rebound post-infusion.

These findings represent a significant milestone in AGT’s mission to deliver a durable, immune-based solution to HIV. The data also reinforces the value of AGT103-T as a first-in-class cell and gene therapy platform targeting latent reservoirs, a key obstacle in achieving viral eradication or long-term remission without antiretroviral therapy.

“While still preliminary, these clinical outcomes are promising signs that an HIV cure is within reach,” said Dr.Wm David Hardy, AGT Scientific Advisory Board member and veteran HIV researcher. “The ability to establish viral control and, as these data demonstrate in an unprecedented manner, deplete the intact proviral reservoir holds exciting promise for the field.”

AGT plans to initiate additional trials in 2026 to further validate these findings in a larger cohort and refine ATI timing and monitoring strategies. The company is actively exploring strategic partnerships to accelerate development and expand access to this novel therapeutic.

About AGT103-T
AGT103-T is an autologous T cell therapy that genetically modifies a patient’s own cells to resist HIV infection and enhance immune control. The treatment is administered as a single infusion and is being evaluated for its ability to reduce or eliminate the need for lifelong antiretroviral therapy.

About American Gene Technologies
American Gene Technologies is a pioneering gene and cell therapy company with a robust platform for developing curative treatments for infectious diseases, cancer, and rare disorders. AGT is headquartered in Rockville, Maryland.

Investor & Partnership Inquiries:
Jim Shaffer
Chief Business Officer
jim.shaffer@americangene.com

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