AGT Celebration of First Safety Data In the HIV Cure Human Trial

On July 29th, 2021, we celebrated amazing news regarding the human trial of our HIV Cure Program. The Data and Safety Monitoring Board (DSMB) voted unanimously to continue AGT’s HIV Cure Program without modification after safety analysis of the first participant’s data revealed no adverse effects from the treatment AGT103-T. We are now one step closer to a functional cure for HIV after this critical milestone!

On November 9th, 2021, AGT announced that the DSMB recorded no serious adverse events in the third participant infused with AGT103-T, allowing the clinical trial to accelerate greatly as the DSMB eliminated the requirement of reviews between each patient.

Read the full press release regarding the third infusion here: https://www.prweb.com/releases/american_gene_technologies_passes_major_milestone_in_potential_hiv_cure_clinical_trial_with_third_patient_showing_no_serious_adverse_effects_saes/prweb18319153.htm

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. AGT 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. AGT's unique approach focuses on repairing the key immune system damage caused by HIV. AGT’s goal is to develop a cell and gene therapy capable of repairing the immune system so it will provide natural control over HIV replication. AGT’s Phase 1 trial for AGT103-T is currently underway at trial sites in the Maryland / Washington, DC area. The recruitment status of the phase 1 RePAIR (Restore Potent Antiviral Immune Responses) clinical trial along with information of the trial sites can be found on ClinicalTrials.gov. The trial is the company’s first step in clinical testing of cell and gene therapies for HIV, cancer, and rare diseases.

About American Gene Technologies

AGT is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of cell and gene therapies to cure infectious diseases, cancers, and inherited disorders. AGT's mission is to transform people's lives through genetic medicines that rid the body of disease. AGT 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. AGT's 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 2022.

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