American Gene Technologies® Phase I HIV Gene Therapy Clinical Trial Data Published in Frontiers Journal Shows Success in Safety & Durability

American Gene Technologies has recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial

American Gene™ Plans for Phase 2 Trial of AGT103-T

American Gene Technologies®, a clinical-stage biotechnology company based in Rockville, Maryland, has recorded data that meets the primary and secondary endpoints of its AGT103-T Phase 1 trial. The Phase 1 trial demonstrated that AGT103-T — an autologous T cell product that has been modified with the AGT103 lentiviral vector for HIV resistance — was well-tolerated in humans and that these enhanced T cells persist in the body, ready to respond to HIV. Data from this first-in-human study of AGT103-T has been published in Frontiers.


Having collected data from the Phase 1 clinical trial, the company expects to submit the final Phase 1 trial report to the U.S. Food and Drug Administration (FDA) in 2023. American Gene is currently writing the protocol of a Phase 2 for FDA consideration to continue the clinical development of this potential cure for HIV.


“Our primary goal concerned safety of the cell product in low and high doses,” explained Jeff Galvin, CEO and founder of American Gene Technologies. “Our secondary objective included measuring responses to treatment, persistence of AGT103-T in vivo, responses to HIV peptide stimulation, and ability to coordinate a killer T cell response to HIV upon stimulation.”


The modified T cells were successfully infused into trial participants with no serious adverse events (SAEs) at low or high doses. Follow up monitoring showed no SAEs, and the collected blood data revealed that the modified T cells engrafted back into the body, coordinated with killer T cells, and persisted in the body, capable of responding to the target HIV peptide upon stimulation.


AGT103-T cells have enhanced RNA interference capabilities against HIV, and lack the CCR5 co-receptor necessary for HIV to enter helper T cells. These modifications in combination with their demonstrated durability give American Gene™ an optimistic outlook for a functional cure for HIV.


In 2021, this Phase 1 trial was approved to begin an additional analytic treatment interruption (ATI) study, which is still ongoing. American Gene is reporting on data from the ATI as well as further clinical observations upon the conclusion of the ATI study.


After a preliminary review of the early immunological data from the ATI participants, the National Institute of Allergy and Infectious Diseases (NIAID) reengaged with American Gene. NIAID will be conducting viral reservoir and B cell measurements, which will provide critical data about the company’s theory as they progress toward a potential HIV cure.


About HIV

According to UNAIDS, approximately 37.7 million people worldwide live with HIV/AIDS. In the United States, government statistics show 1.2 million people have HIV and estimate that 34,800 Americans were newly infected with HIV in 2019. Across the globe, UNAIDS estimates that approximately 1.5 million individuals were newly infected with HIV in 2020. The Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV, with Washington, D.C., having the highest rate of infection at nearly 46 cases per 100,000 population and Baltimore City having rates of 17 cases per 100,000. Maryland also ranks sixth among U.S. states and territories in HIV diagnosis rates, with more than 900 new cases in 2019 alone, according to the Maryland Department of Health.


Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatment has demonstrated the ability to cure HIV. American Gene Technologies is committed to addressing this unmet medical need.


About AGT103-T

AGT103-T is a genetically modified cell product made from a person's own cells. American Gene Technologies’ unique approach focuses on permanently repairing the key immune system damage caused by HIV. American Gene Technologies’ goal is to develop a gene therapy capable of repairing the immune system so it will provide natural control over HIV replication.


About American Gene Technologies

American Gene Technologies is a gene therapy company with a proprietary gene-delivery platform for rapid development of gene therapies to cure infectious diseases, cancers, and inherited disorders. Its mission is to transform people's lives through genetic medicines that rid the body of disease. American Gene Technologies has been granted four patents for the technology used to make AGT103-T and 11 patents for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors. The company has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. American Gene Technologies' treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2023.


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