FDA APPROVES AMERICAN GENE TECHNOLOGIES (AGT) TO MOVE FORWARD WITH PHASE 1 CLINICAL TRIAL OF HIV CURE PROGRAM
Our Vision for an HIV Cure Attempt
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.
Watch clips from AGT's red carpet event celebrating its IND submission to the FDA.
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:
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.
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.
Immunotherapy for HIV disease with gene modified T cells
Activates innate T cell immunity capable of killing all tumor cells with its vector used in immuno-oncology
Treats PKU by bringing a functional gene into cells that express a dysfunctional gene due to mutation
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 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.
C. David Pauza, PhD
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.
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.
Kelly Huang, PhD
Kelly brings more than 10 years of experience in biopharma drug development, and has lead teams to support the development of drugs targeting diverse therapeutic areas including infectious disease, autoimmunity, and oncology.
AGT's Core Objectives
Is the cure for cancer right around the corner?…
Advances in gene technologies and the resulting cures are accelerating exponentially while costs are coming down. If you were in Silicon Valley for the last 35 years, you’d recognize parallels to many previous high-tech “explosions” such as microcomputers, software and the Internet. “Moore’s Law” now applies to drug development and the next big startup could be up in a garage near you! Forget zeroes and ones… A-C-G-T is the new growth area of programming and real-world solutions. Viva la revolution!