HIV

Getting Close to a Potential Cure with Gene Therapy

HIV

Getting Close to a Potential Cure with Gene Therapy

American Gene Technologies’ HIV Cure Program is currently in a Phase 1 human trial.

The Future of Medicine

American Gene Technologies recognizes that gene therapy is so effective at curing diseases because it allows us to “edit” a cell’s operating system (its DNA) to correct the code or commands (genes). Gene therapy enables us to develop more specific and directed treatments and cures with fewer side effects because the drugs target diseased cells and avoid healthy tissue. American Gene is making great progress in our ongoing Phase 1 clinical trial where we are testing a gene therapy treatment that could potentially cure HIV.

Latest News on HIV Clinical Trial Progress

21_AGT Investor Page Red Check

This is a pivotal step to potentially demonstrating a gene therapy cure for HIV.

17_AGT Investor Page Blue Check

First Three Participants Showed No Serious Adverse Events

18_AGT Investor Page Teal Check

First Participant Was Infused With AGT103-T

HIV Science Advisory Board

09_AGT HIV Page John Rossi

John J. Rossi, PhD

City of Hope,
Duarte, California

10_AGT HIV Page Robert Clarke

Robert Clarke, PhD, DSc

Georgetown University
Medical School

11_AGT HIV Page Dean Felsher

Dean W. Felsher, MD, PhD

Stanford University
School of Medicine

12_AGT HIV Page Jerry Vockley

Jerry Vockley, MD, PhD

University of Pittsburgh
School of Medicine

13_AGT HIV Page Fred Nyberg

Fred Nyberg, PhD

Uppsala University,
Sweden

HIV Program Milestones

8.3.22_New_Timeline_Graphic_V1_-_AGT

American Gene Technologies' Plan for Immunotherapy of HIV

Our plan is simple. If the HIV-specific CD4 T cells are missing and this explains why treatment must be continued for life, we should replace the missing cells with new ones. When a person has enough of the HIV-specific memory CD4+ cells, natural immune control of HIV should be restored.

newPage-Plan-Graphicnew

AGT103-T is a single does autologous cell therapy delivering gene-modified, HIV specific CD4 T cells to persons with HIV disease.

By repairing CD4 T cell immunity to HIV, AGT103-T promotes natural virus control and durable immunity from reinfection.

Rationale for AGT103-T

The manufacturing of specific T cells is used increasingly to make treatments for infectious diseases and cancer. In most cases, the processes are straightforward and cells are highly effective after injecting back into the person suffering from a disease.

 

A new industry is springing up around the need for cell manufacturing and is providing automation of highly efficient cell processing for T cell-based products. In most cases, specific cells are purified, grown to large numbers outside the body, then injected back in as a living cell therapy using the person’s own cells so there is no risk of rejection.

HIV infection depletes virus-specific CD4 T cells that are not reconstituted despite years of ART.

The critical CD4 T cell subset is the Gag-specific CD4 T call population (around 10-4 frequency in persons with chronic, progressive HIV and virus suppressed by ART).

Elite controllers (EC) and long-term non-progressors (LTNP) are distinguished by much higher levels of Gag-specific CD4 T cells.

American Gene Technologies created a cell and gene therapy to raise Gag-specific CD4 T cell levels in patients with chronic, progressive disease and mimic the condition of EC and LTNP individuals.

Reconstituted Gag-Specific CD4 T cells may support durable immunity to HIV and reduce or eliminate the need for ART.

HIV infection depletes virus-specific CD4 T cells that are not reconstituted despite years of ART.

The critical CD4 T cell subset is the Gag-specific CD4 T call population (around 10-4 frequency in persons with chronic, progressive HIV and virus suppressed by ART).

Elite controllers (EC) and long-term non-progressors (LTNP) are distinguished by much higher levels of Gag-specific CD4 T cells.

American Gene Technologies created a cell and gene therapy to raise Gag-specific CD4 T cell levels in patients with chronic, progressive disease and mimic the condition of EC and LTNP individuals.

Reconstituted Gag-Specific CD4 T cells may support durable immunity to HIV and reduce or eliminate the need for ART.

Patented Lentivirus Vector AGT103-T

20_AGT HIV Page Lentivirus Graphic 1

AGT103-T gives CD4 T cells the ability to survive attack by HIV and support effective antiviral immune response

19_AGT Investor Page Green Check

Efficient transduction of primary CD4 T cells

20_AGT Investor Page Yellow Check

Blocks HIV infection by CCR5- and CXCR4-tropic viruses

21_AGT Investor Page Red Check

Prevents HIV replication in latently-infected reservoir cells

Manufacturing Cell Products for Treatment of HIV Disease

We developed a highly efficient, cost-effective process for manufacturing large numbers of HIV-specific cells, modifying them with lentivirus vector AGT103-T, and infusing them back into the body as a single dose, autologous cell therapy.

22_AGT HIV Page Cell Product Graphic

Three Key Features of the AGT103-T Product Are:

The lentivirus vector modifies HIV-specific CD4 T cells and: prevents infection by CCR5- or CXCR4-tropic strains of HIV; reduces depletion of CD4 T cells during exposure to HIV; and prevents a latently-infected cell from releasing new HIV virus particles.

The process for cell manufacturing is reliable and consistent; this is important for supporting clinical trials.

AGT103-T starts with about 1 million HIV-specific CD4 T cells obtained from blood and, by the end of production, delivers about 1 billion HIV-specific CD4 T cells with most of them modified by the AGT103-T lentivirus vector.

By achieving this high dose of HIV-specific CD4 T cells that are protected from attack by HIV, we expect this treatment to reconstitute the immune system and restore an ability to make antiviral immune responses for natural control of HIV. 

HIV Clinical Trial Progress

American Gene Technologies’ first-in-human study for AGT103-T is currently underway at trial sites in the Washington, D.C. area. Participants in the Phase 1 trial received a single infusion of their own HIV-specific CD4 T cells after those cells were enriched and genetically modified to resist infection.

 

Seven patients have received AGT103-T and have experienced no serious adverse events, thereby demonstrating the therapy’s safety. Blood markers in the treated patients have provided a view into how the cell therapy is responding in their bodies. So far, the data has confirmed that the cells are properly engrafting, persisting, and seem to be remaining uninfected while reacting to, and likely fighting HIV the way scientists expected.

 

The independent Institutional Review Board (IRB) overseeing the clinical trial approved the next step of the clinical trial: analytic treatment interruption (ATI). Withdrawing each participant from their antiretroviral drugs will reveal whether they are cured of HIV, meaning they no longer need daily medication, and can’t develop AIDS or become re-infected with HIV. American Gene Technologies expects to reveal results of the ATI by the end of this year (2022).

Our Commitment to Developing New Treatments for HIV

Our company is developing genetic medicines for unmet medical needs. First among our priorities is a treatment for HIV that restores natural control of viremia and reduces dependence on antiretroviral therapy.

 

We believe natural virus control will be effective and will reduce the costs and side-effects inherent in life-long use of antiretroviral medication. 

These Two Clinical Trial Participants Living with HIV Believe In HIV Cure Research

American Gene Technologies is a private company supported by accredited investors.

Norman Rogers

Business Development

Schedule Call