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)
- Granted FDA Orphan Drug Designation for the treatment of PKU
Phenylketonuria (PKU)
- Granted FDA Orphan Drug Designation for the treatment of 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
John J. Rossi, PhD
City of Hope,
Duarte, California
Robert Clarke, PhD, DSc
Georgetown University
Medical School
Dean W. Felsher, MD, PhD
Stanford University
School of Medicine
Jerry Vockley, MD, PhD
University of Pittsburgh
School of Medicine
Fred Nyberg, PhD
Uppsala University,
Sweden
W. David Hardy, MD, AAHIVS
Johns Hopkins University, School of Medicine
Ely Benaim, MD
Chief Medical Officer,
Novocure
Jean Jacques Fournié, PhD
University of Toulouse Cancer Center, France
Marc Bonneville, PhD
Institute Mérieux
France
