Pipeline
Overview

Pipeline
Overview

With over a decade of advanced research and development, American Gene Technologies® has built a broad, robust gene delivery platform that accelerates the development of a wide variety of drug candidates.

This platform allows American Gene Technologies to pursue exciting clinical “cures” in large and orphan indications to complex diseases. American Gene Technologies has an extensive and growing patent portfolio protecting its lentiviral vector and proprietary process for generating autologous cell products that treat HIV as well as its methods and Composition for the Activation of Gamma Delta T cells to kill solid cancer tumors.

Using its platform and patented methods, American Gene Technologies has built a rich product pipeline of genetic therapies for patients suffering from infectious diseases, monogenic disorders, and cancer.

AGT103-T, our HIV therapeutic, is currently in Phase 1 clinical trials, and we expect to see the lead candidates in our Immuno-oncology and Phenylketonuria (PKU) programs move into the clinic in the next few years as well.

HIV CURE PROGRAM

  • Granted patents to protect its lentiviral vector and proprietary process for generating autologous cell products for treating HIV (“HIV Pre-Immunization and Therapy”)
  • Signed research agreement with NIAID for Experimental HIV/AIDS Cure Strategy
  • Former scientific advisor, Robert R. Redfield, M.D., was appointed Director of the Centers for Disease Control and Prevention (CDC)
  • Completed process development for the AGT103-T automated cell manufacturing protocol; the GMP vector for the HIV cure program was completed.
  • Selected University of Maryland, Baltimore County (UMBC) as the new clinical site for its non-IND study, AGT-CS168, to collect sample venous blood specimens from people living with HIV.

HIV CURE PROGRAM

  • Granted patents to protect its lentiviral vector and proprietary process for generating autologous cell products for treating HIV (“HIV Pre-Immunization and Therapy”)
  • Signed research agreement with NIAID for Experimental HIV/AIDS Cure Strategy
  • Former scientific advisor, Robert R. Redfield, M.D., was appointed Director of the Centers for Disease Control and Prevention (CDC)
  • Completed process development for the AGT103-T automated cell manufacturing protocol; the GMP vector for the HIV cure program was completed.
  • Selected University of Maryland, Baltimore County (UMBC) as the new clinical site for its non-IND study, AGT-CS168, to collect sample venous blood specimens from people living with HIV.

IMMUNO-ONCOLOGY

  • Granted patents to protect its lead asset in immunotherapy for cancer (“Methods and Composition for the Activation of Gamma Delta T cells”)
  • Launched Oncology Science Advisory Group (OSAG) of globally recognized scientists to accelerate its immuno-oncology cancer cure program

IMMUNO-ONCOLOGY

  • Granted 8 USPTO patents to protect its lead asset in immunotherapy for cancer (“Methods and Composition for the Activation of Gamma Delta T cells”)
  • Launched Oncology Science Advisory Group (OSAG) of globally recognized scientists to accelerate its immuno-oncology cancer cure program

Phenylketonuria (PKU)

Phenylketonuria (PKU)

FDA Designation & Patents

American Gene Technologies HIV, PKU and Cancer technologies are covered by an extensive patent portfolio. DLA Piper Global Law Firm and Snell & Wilmer serve as American Gene patent counsels. 

 

In addition, American Gene has been granted FDA Orphan Drug Designation for its treatment of PKU.

Scientific & Clinical Advisors

1 John Rossi - Blue

John J. Rossi, PhD

City of Hope,
Duarte, California

Dr. Robert Clarke, PhD, DSc

Robert Clarke, PhD, DSc

Georgetown University
Medical School

Dean W. Felsher, MD, PhD

Dean W. Felsher, MD, PhD

Stanford University
School of Medicine

Dr. Jerry Vockley, MD, PhD

Jerry Vockley, MD, PhD

University of Pittsburgh
School of Medicine

Dr. Fred Nyberg, PhD

Fred Nyberg, PhD

Uppsala University,
Sweden

W. David Hardy, MD, AAHIVS

W. David Hardy, MD, AAHIVS

Johns Hopkins University, School of Medicine

Dr. Ely Benaim, MD

Ely Benaim, MD

Chief Medical Officer,
Novocure

8 Jean Jacques Fournié -Green

Jean Jacques Fournié, PhD

University of Toulouse Cancer Center, France

9 Marc Bonneville - Yellow

Marc Bonneville, PhD

Institute Mérieux
France

10 Julie Déchanet-Merville - Red

Julie Déchanet-Merville, PhD

Bordeaux University
France