Molecular Therapy Peer-Reviewed Article by AGT and NIAID Outlines Preclinical Data, Shows Potential for HIV Functional Cure

ROCKVILLE, Md., July 30, 2020 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT), an internationally recognized advanced gene and cell therapy company in Rockville, MD, today announced a coauthored article by scientists from AGT and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), regarding AGT’s promising cell and gene therapy for HIV.

Through a collaboration agreement initiated in 2019 between AGT and NIAID, government researchers studied the mechanism of action for AGT103-T, AGT’s proprietary, genetically modified, autologous cell product, to define its potential impacts on HIV. AGT’s prior studies suggested the enrichment of HIV-specific CD4 T cells in their AGT103-T autologous cell product can provide increased helper and effector activities capable of reducing the HIV burden, improving therapy, and potentially leading to a functional cure.

Under the agreement, NIAID provided detailed characterization of CD4 T cells in the company’s AGT103-T cell product and insight into mechanisms of action for this biological drug that may benefit people living with HIV. The publication describes the evolution of the AGT103-T manufacturing process as researchers developed the large-scale production of modified HIV-specific, CD4 T cells that resist infection and depletion by HIV.

HIV disease is characterized by the extensive loss of and failure to reconstitute HIV-specific CD4 T cells, which leads to chronic infection and disease. Replacing these cells with genetically modified, HIV-specific CD4 T cells that resist HIV infection and depletion may restore the capacity for natural immune control of disease. Experimentation performed by AGT and the laboratory of NIAID’s Tae-Wook Chun, PhD, confirmed the process for large-scale production of HIV-specific CD4 T cells and characterized these unique cells. AGT103-T shows the potential for clinical impact on HIV disease.

“The combined skill and experience of the AGT team working with researchers at NIAID have advanced our understanding of AGT103-T cell properties and opened the door to clinical trials of this unique and highly promising cell and gene therapy for HIV disease,” said C. David Pauza, PhD, Chief Science Officer at AGT.

“The levels of potency in the AGT103-T cell product that has been repeated and validated by NIAID has given AGT further confidence that antiretroviral therapy-free HIV remission could be achieved in the near future,” said Jeff Galvin, CEO of AGT.

Link to Molecular Therapy Article:

https://www.cell.com/molecular-therapy-family/methods/fulltext/S2329-0501(20)30084-X

About American Gene Technologies

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. The Company's mission is to transform people's lives through genetic medicines that rid the body of disease. The Company expects to take its patented lead candidate for an HIV cure to the clinic in 2020. AGT has an extensive patent and intellectual property portfolio spanning infectious disease, monogenic disorders, and cancer, including seven 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 an optimized 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 2021.

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