American Gene Technologies® Major Milestone Announcements



American Gene Technologies (AGT™), a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company — Addimmune — to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.

About Addimmune

Addimmune was founded in 2023 to cure HIV with promising gene therapy technologies. Building upon the success of American Gene Technologies’ HIV clinical trial, Addimmune is solely focused on developing and commercializing an effective and lasting cure for HIV. Learn more about Addimmune in this video:

About American Gene Technologies

American Gene Technologies is a gene and cell 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. Safety data from American Gene Technologies’ Phase 1 HIV gene therapy clinical trial is published in the Frontiers in Medicine journal. In addition, the company has been granted broad patent protection for the technology used to make AGT103-T. Numerous other patents have been granted for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors, as well as other important innovations and discoveries that are useful across a wide variety of gene and cell therapy applications. American Gene Technologies has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. The company’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 2025.

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12 Comments

  1. We should campare the Anti-HIV duo CAR-T cell therapy to [A] Excision BioTherapeutics' EBT-101 and [B] American Gene Technologies' AGT103-T .

    [1]. Anti-HIV duo CAR-T cell therapy .
    CAR-T cell therapies has been successful in treating patients with cancer and lupus. So far, two HIV+ patients received the CAR-T cell therapy, which which is currently in Phase 1/2 human clinical trials. This Anti-HIV duo CAR-T cells involves the patent's own white bloods cells, called T-cells and modifying them so these modified T-cells identify and target HIV cells (HIV envelope glycoprotein 120) to control the virus. The first two participants was dosed with the Anti-HIV duo CAR-T cells at the UC Davis Medical Center in August 2022.

    [2]. Excision BioTherapeutics' EBT-101  as a potential "sterilizing cure".  EBT-101 is currently in human clinical trials and in September 2022, Excision BioTherapeutics dosed their first participant in the EBT-101 Phase 1/2 Trial. EBT-101 is CRISPR-based, single administered therapy, designed to cut and removing HIV DNA out of human cells. This potential gene editing treatment employs an adeno-associated virus to deliver CRISPR-CAS9 nucleases and dual guide RNAs targeting three sites within the HIV genome that tell the enzymes where to cut.

    [3]. American Gene Technologies' AGT103-T as a possible "functional" cure. AGT103-T is currently in human clinical trials and in June 2021, the first patent was treated with potentially curative HIV cell and gene therapy. AGT103-T is a cell product made from an individual's own cells and modified with AGT103 lentiviral vector for HIV resistance. The Phase 1 trial found that AGT103-T was well tolerated in humans and persisted in the body. AGT103-T is designed to restore the Gag-speciffic CD4+ T cell response in persons with chronic HIV who are receiving antiretroviral therapy.

    Out of CAR-T cell therapy, AGT103-T and EBT-101, which therapy will be first to advance to Phase 2 human clinical trials, then to Phase 3 FDA approval then approved for distribution?

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