American Gene Technologies Hosts Celebration Event For Its First IND Submission (For HIV) To The Food and Drug Administration (FDA)

ROCKVILLE, Md., Nov. 06, 2019 (GLOBE NEWSWIRE) -- American Gene Technologies (AGT) announced today it will host a red carpet event tonight to celebrate a significant milestone in the company’s 11-year history of scientific research in cell and gene therapy: AGT successfully submitted its Investigational New Drug (IND) application to the Food & Drug Administration (FDA) to begin a Phase 1 clinical trial for its genetically modified autologous cell therapy for HIV. This milestone was announced on October 18th (read press release).

The event brings together over 370 guests, including life science industry leaders, government, press, and the entire AGT team. It is intended not only to celebrate AGT’s growth and development, but it is meant to celebrate the growing Maryland biotech industry and to energize “DNA Valley,” the cell and gene therapy industry cluster of Maryland.

“We believe in collaborating within our community and industry as we grow. Events like this have the potential to ignite synergies within the industry that will help us accelerate our development of therapies that we hope will save lives,” said CEO Jeff Galvin.

The event will take place in the heart of Maryland’s biotech corridor. It will feature live music, drinks, and food for guests. Event details:

Event: American Gene's Red Carpet Event To Celebrate Its IND Submission 
Speakers: Jeff Galvin, David Pauza, PhD, Benjamin Wu, Deputy Secretary of the Maryland Department of Commerce
November 6, 2019
Time:   5pm-8pm EST
Location: Office Park Mall Area, 9715 Key West Avenue
Rockville, MD 20850

The event is private. The event is open to the media, but please contact and for details.

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. 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 into the clinic in 2019. AGT has received 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 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.

About AGT 103-T, AGT’s Therapy It Submitted An IND Application To Begin Human Trials

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.

"Previous cell and gene therapies for HIV provided very low doses of critical virus-specific CD4 T cells that are needed to repair the immune defect caused by HIV. AGT103-T becomes highly enriched in these specific cells during our proprietary 12-day manufacturing process. By providing high doses of virus-specific helper T cells, which are protected from HIV damage by a safe genetic modification, AGT's goal is to rebuild the capacity for normal, unhindered immune responses against HIV that may control the infection and protect against future virus exposures. We believe this product will be suitable for persons in different disease stages and with multiple types of HIV infection," explains Chief Science Officer C. David Pauza, PhD.

AGT has entered into a Research Collaboration Agreement with the National Institute of Allergy and Infectious Diseases (NIAID) and was able to demonstrate AGT103-T's mechanism of action. Read about AGT's NIAID Research Collaboration Agreement here.

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American Gene Technologies Contacts:

C. Neil Lyons, Chief Financial Officer
Phone: (301) 337-2269

Sasha Whitaker, Digital Marketing and Communications
Phone: (301) 337-2100