HIV Cure

Clinical Trial

HIV Cure

Clinical Trial

HIV Cure

Clinical Trial

Follow along with the American Gene Technologies team as we track the clinical progress of AGT103-T, our potentially curative HIV therapeutic!

Latest Clinical Trial Progress

American Gene Technologies’ first-in-human Phase 1 study for AGT103-T is currently underway at trial sites in the Washington, D.C. area. 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 the results of the ATI by the end of this year (2022).

Latest Clinical Trial Progress

American Gene Technologies’ first-in-human Phase 1 study for AGT103-T is currently underway at trial sites in the Washington, D.C. area. 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 the results of the ATI by the end of this year (2022).

HIV Clinical Trial Timeline

MicrosoftTeams-image (4)

HIV Cure Countdown

American Gene Technologies is making great progress in our ongoing HIV clinical trial. Here is a countdown from when we first started this journey in 2019 to 2022. We highlight key milestones we’ve achieved so far, as well as future developments we are working toward — all in an effort to potentially cure HIV.

cmbanner

Share on Social Media

04_AGT Cure Countdown Page graphic

FDA Allows Clinical Trial

August 2020

After promising pre-clinical studies, the phase 1 trial for AGT103-T was 'greenlit' for a Phase 1 human trial.

05_AGT Cure Countdown Page graphic

Phase 1 Began

October 2020

American Gene’s Phase 1 trial officially opened and started seeking trial participants.

06_AGT Cure Countdown Page graphic

First Participant Enrolled

October 2020

The first trial participant was enrolled in the Phase 1 trial of AGT103-T.

07_AGT Cure Countdown Page graphic

First Product Passes Release Testing 

April 2021

After Phase 1 began and the trial participants were enrolled, American Gene manufactured AGT103-T and passed an extensive panel of safety testing.

08_AGT Cure Countdown Page graphic

First Patient Infused

May 2021

The very first trial participant received an infusion of AGT103-T.

09_AGT Cure Countdown Page graphic

Three Patients with No Serious Adverse Events; DSMB Accelerates Trial

November 2021

After no serious adverse events were recorded from the first 3 patients, the DSMB voted unanimously to continue the program at a faster pace. The 4th and 5th patient were treated in November 2021.

10_AGT Cure Countdown Page graphic

First Five Patients Show Critical Efficacy Markers

February 2022

The AGT103-T gene and cell therapy was tested on participants, giving us a sneak peek at efficacy data that normally occurs in Phase 2. The initial data showed blood markers of efficacy in all five clinical trial participants.

Capturccbannere
12_AGT Cure Countdown Page graphic

First Human Efficacy

Upcoming

Given that participants in the study are living with HIV and have been given a therapeutic dose of the experimental drug, American Gene may actually see some patients go into durable remission and be able to go off of their ARTs.

13_AGT Cure Countdown Page graphic

Phase 2 Approved

Upcoming

A successful Phase 1 will lead to a Phase 2 study, which could be pivotal. Gene and cell therapies frequently get limited license in a Phase 2 study. 

14_AGT Cure Countdown Page graphic

Phase 2 Completed

Upcoming

Successful completion of a Phase 2 study may give us the ability to apply for a limited license, sometimes referred to as a BLA. The FDA will consider whether sufficient safety has been shown, and if efficacy is attractive.

15_AGT Cure Countdown Page graphic

Biologics License Agreement (BLA)

Upcoming

We’re hopeful that our clinical successes will merit a license. Provided the successful clinical studies, the BLA will allow American Gene Technologies to offer the therapy commercially. 

Have Questions? Get Answers.

Visit our knowledge base for answers to FAQs about American Gene Technologies' HIV cure program and Phase 1 clinical trial.

How Does AGT103-T Work?

Watch our CEO break down American Gene Technologies' gene and cell therapy strategy for curing HIV.

As we work toward the next milestone in the HIV Cure Program, learn more about the history of HIV that has been developing over the last 40 years.

We're happy to help

Contact Us

Primary IR Contact

Norman Seth Rogers

Business Development, Investor Relations