FDA Approves American Gene Technologies (AGT) to Move Forward with Phase 1 Clinical Trial of HIV Cure Program

ROCKVILLE, Md., Aug. 11, 2020 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT) announced today approval by the FDA (Food and Drug Administration) to begin Phase 1, the first human clinical trial for AGT’s lead HIV program. AGT will conduct its Phase 1 study at clinical sites in the Baltimore/D.C. area, and has named Washington Health Institute, University of Maryland, Institute of Human Virology and Georgetown University as its initial trial sites. These sites are expected to begin enrollment in September 2020.  AGT hopes to report initial data before the end of the year.

AGT’s Phase 1 trial will 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.

HIV has affected society for more than four decades. Globally, nearly 38 million people have been infected with HIV and over one million people in the United States are living with HIV. So far, efforts to cure the disease have been unsuccessful. AGT developed a new treatment to repair immune system damage done by HIV and allow natural responses to control the virus. From its research, AGT believes a cure is attainable and 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 demonstrates the ability to clear itself of HIV when challenged with the virus and HIV-infected human cells.

AGT’s characterization of AGT103-T was done in collaboration with government 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.

A peer-reviewed article co-authored by AGT and NIAID scientists was published in Molecular Therapy in June 2020 (read published article). 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.

The levels of potency in the AGT103-T cell product that have been repeated and validated by NIAID have given AGT further confidence that antiretroviral therapy-free HIV remission could be achieved soon. According to AGT founder and CEO Jeff Galvin, “I am confident AGT103-T will be an important step towards an eventual cure for HIV.”

"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 Chief Science Officer David Pauza, Ph.D. “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.”

Phase 1 in Maryland

Maryland ranked fifth of all U.S. states and territories in HIV diagnosis rates, with nearly 1,000 new cases in 2018 alone according to the Maryland State Department of Health. The Washington, D.C. metropolitan area, including Baltimore, is a hotspot for HIV/AIDS.  Our clinical trial sites in the metro area will test our new treatment in populations hardest hit by HIV.

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About HIV

Today, approximately 37.9 million people worldwide and 1.2 million people in the United States are living with HIV/AIDS. The U.S. government has estimated that 38,900 Americans were newly infected with HIV in 2018 and 1.7 million individuals globally were infected with HIV in 2018. Locally, 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 48 infections per 100,000 population and Baltimore City with similarly high infection rates of 36 per 100,000.

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 treatments can cure HIV. This is an unmet medical need that AGT is closer to addressing.

About AGT 103-T

AGT103-T is a genetically-modified cell product made from a person's own cells. AGT's approach is unique in that it focuses on repairing the key immune system damage caused by HIV. When HIV infection causes this specific damage, killing of T helper cells required for immunity to HIV, the infected person becomes unable to eliminate the virus and thus, becomes chronically infected. AGT's approach is designed to repair the T helper cell defect and provide durable virus control that is not compromised by HIV strains that vary in sequence or use alternate ways to enter and infect T cells. AGT's AGT103-T HIV therapeutic drug should work to remove infected cells from the body and decrease or eliminate the need for lifelong antiretroviral treatment.

About American Gene Technologies (AGT)

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 received 3 patents for the technology used to make the AGT103-T cell product and ten 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 2020.

FOR MEDIA: Register Now for AGT’s Virtual Press Conference
AGT will be hosting a virtual press conference to provide the media details regarding the AGT103-T autologous cell therapy, pre-clinical results, clinical sites, enrollment plan, and timelines. If you are a member of the media and would like to attend this 1-hour press conference, please register here: (click link)

American Gene Technologies Contacts:

C. Neil Lyons, Chief Financial Officer
Phone: (301) 337-2269
Email: info@americangene.com

Sasha Whitaker, Digital Marketing and Communications
Phone: (301) 337-2100
Email: swhitaker@americangene.com

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