The US Food and Drug Administration (FDA) has granted approval for American Gene Technologies (AGT) to commence Phase I of the first human clinical trial for its lead HIV program. The firm plans to conduct the Phase I study at sites in the Baltimore, Maryland and Washington, DC.
"This is momentous news that we have FDA approval to launch Phase 1 and conduct our first human trials. We are beyond excited to reach this milestone. This brings us closer to our goal of transforming lives with genetic medicines,” said AGT’s chief science officer David Pauza. “Based on our successful commercial-scale product manufacturing runs and features of the product observed in our labs, this therapy has a high potential to be effective.”
According to AGT, the study’s initial trial sites will be at the Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University. The sites expect to kick off in September 2020, with AGT reportedly hoping to report initial data before the end of the year.
The Phase I clinical trial is designed to investigate the safety of AGT103-T, measure key biomarkers and explore surrogate markers of efficacy. AGT103-T is a single-dose, lentiviral vector-based gene therapy developed to eliminate HIV from the millions of people globally infected with the disease.
Since HIV first drew worldwide attention, nearly 38 million people reportedly have been infected with HIV, with over 1m Americans currently living with the virus. While a number of treatments exist for HIV, no cure for the virus has been approved to date.
AGT’s new treatment is intended to repair immune system damage done by HIV and allow natural responses to control the virus. AGT reports that research has led its team to believe a cure is attainable, and it is now taking the significant step of testing in humans.
The AGT103-T cell product is made from blood cells using an 11-day process that increases the HIV-fighting T cells and uses a gene therapy to help these cells survive in the body. The product reportedly shows the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells.
AGT’s characterization of AGT103-T was executed in collaboration with researchers from the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health. Under a Collaborative Research 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.
AGT and NIAID scientists co-authored an article, peer-reviewed and published in Molecular Therapy. 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. The upcoming Phase 1 study will allow AGT to examine the effect of AGT103-T in a clinical setting which was previously demonstrated in preclinical human cell models.
Jeff Galvin, AGT founder and CEO, said, “I am confident AGT103-T will be an important step towards an eventual cure for HIV.”