Rapid Drug

Development Platform

Advanced Gene & Cell

Therapy Platform

Yielding Cures for Serious Diseases

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HIV Cure Program

Therapy In Clinical Trials To

Make HIV+ Individuals Immune to HIV

Without The Use Of Daily Antiretrovirals

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Cancer Cure Program

Stimulating the Natural Immune System

(Gamma Delta T Cells) to Safely Remove

Solid Tumors

Human Trial Forecast for 2023

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Phenylketonuria

Cure Program

A One Time Treatment For PKU

That Lasts a Lifetime

Forecast for Human Trials 2022

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Rapid Drug Development Platform

Advanced Gene & Cell Therapy Platform
Yielding Cures for Serious Diseases

VIEW PIPELINE

HIV Cure Program

Therapy In Clinical Trials To Make HIV+ Individuals Immune to HIV
Without The Use Of Daily Antiretrovirals

LEARN MORE

Cancer Cure Program

Stimulating the Natural Immune System (Gamma Delta T Cells)
to Safely Remove Solid Tumors
Human Trial Forecast for 2023

LEARN MORE

Phenylketonuria Cure Program

A One Time Treatment For PKU That Lasts a Lifetime
Forecast for Human Trials 2022

LEARN MORE

JULY 15, 2021: AGT receives a unanimous vote to continue AGT’s HIV cure program without modification after safety analysis of the participant’s data revealed no adverse effects from AGT103-T. 

Our Vision for an HIV Cure

HIV Cure Project Initiated: October 2016. AGT meets with the FDA and defines a path forward for AGT103-T. FDA outlines safety requirements and greenlights further development.

IND Submission: October 2019. The Investigational New Drug (IND) application provides preclinical data and a rationale for why this unique immuno-regulatory approach is worthy of advancing into the clinic.

IND Approved - Clinical Trials Begin: August 2020, FDA approves the IND and clears AGT to begin a Phase 1 human trial.

First Patient Enrolled - October 2020. AGT begins the Phase 1 trial for AGT103-T, and the first trial participant is expected to be infused early in 2021.

Initial Safety Data - July 2021. The first participant experiences no adverse events; USMB reviews safety data and approves continuation of study.

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Watch clips from AGT's red carpet event celebrating its IND submission to the FDA.

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Who We Are

American Gene Technologies International Inc. (AGT) is a private biotechnology company pursuing cures and treatments for infectious diseases, cancers and monogenic disorders.
AGT's programs are designed to:

Create immunotherapy for HIV disease with gene modified T cells
Activate innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology
Treat PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation
Advance clinically to provide human proof of concept

What We Do

For over a decade, AGT has developed, tested and banked thousands of lentiviral vectors that can be adapted to the specific needs of new target diseases. AGT has developed gene therapy for diseases using this rapid gene delivery platform.

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Gene Therapies

AGT’s platform allows it to pursue clinical “cures” for complex diseases. The company has developed patent-protected gene therapeutics that are breakthroughs in medicine.

GENE THERAPY

HIV/AIDS

Immunotherapy for HIV disease with gene modified T cells

IMMUNO-ONCOLOGY

Activates innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology

GENE THERAPY

Phenylketonuria (PKU)

Treats PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation

Pipeline

American Gene Technologies™ (AGT) is building a rich product pipeline based on its lentiviral vector platform. Our three lead programs are well into the laboratory phase and scheduled to move into the clinic over the coming months.

Our Executive Team

American Gene Technologies™ (AGT) is building a rich product pipeline based on its lentiviral vector platform. Our three leading therapeutics are well into the laboratory phase and scheduled to move into the clinical phase over the course of the next 6-18 months. AGT is in the process of testing and commercializing genetic medicines that will cure or halt the progression of several major diseases.

Jeff Galvin CEO of American Gene

Jeff Galvin

CEO and
Founder

Jeff earned his BA degree in Economics from Harvard in 1981. He has more than 30 years of business and entrepreneurial experience including founder or executive positions at a variety of Silicon Valley startups. Several of his companies were taken public and/or sold to public companies.

Dr. David Pauza

C. David Pauza, PhD

Chief Science
Officer

David has 35 years of experience in HIV, immunology, virology, and cancer biology, and has held faculty positions and at University of Wisconsin and University of Maryland medical schools. Prior to joining AGT, David was Adjunct Professor of Medicine at the University of Maryland Medical School in Baltimore.

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C. Neil Lyons, CPA

Chief Financial Officer &
Executive Vice President

Neil has more than 30 years of experience in finance, strategy, raising capital, SEC compliance, and corporate governance in both public and private companies, with over 10 years of that leading finance for publicly-traded, clinical-stage biotechnology companies.

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AGT's Core Objectives

Leverage our lentivirus platform to create highly-effective targeted genetic medicines
Create solutions for patients across a spectrum of infectious diseases, cancers and inherited disorders
Collaborate with leading medical researchers from around the globe
Partner with pharmaceutical and biotech firms on indication and platform-specific opportunities
Enhance our proprietary platform to expedite drug development

Cutting Edge Methods to Kill Cancer

AGT’s innovative immuno-oncology program aims to create genetic drugs that increase treatment potency, broaden the range of cancers treated, and provide the greatest value for patients. This led to the development of the ImmunoTox program, a genetic medicine introduced by a lentiviral vector delivered to sites of solid tumor growth where it penetrates tumor cells and alters their normal metabolism. The ImmunoTox program’s novel approach causes the build up of a small molecule danger signal that activates γδ T cells to kill cancer cells.

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