Addimmune HIV Cure Clinical Trial
Follow along with the Addimmune™ team as we track the clinical progress of AGT103-T, our potentially curative HIV therapeutic!
Clinical Trial Progress
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HIV Cure Countdown
This HIV Cure Countdown outlines the critical milestones accomplished so far. We still have a few more to go, so follow along with us as we pursue a gene therapy cure for HIV.
10
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.
CBS News Baltimore WJZ: "FDA Clears Maryland Company’s Potential HIV Cure For Human Trials"
ABC 7 News WJLA: "MoCo biotech company receives FDA approval for human trials of HIV Cure program"
9
Phase 1 Began
October 2020
American Gene™ Phase 1 trial officially opened and started seeking trial participants.
8
First Participant Enrolled
October 2020
The first trial participant was enrolled in the Phase 1 trial of AGT103-T.
7
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.
6
First Patient Infused
May 2021
The very first trial participant received an infusion of AGT103-T.
HIV Breakthrough at American Gene Technologies Gets Researchers Closer to the Cure
HIV Cure Program Clinical Trial Update - Spring 2021
AGT Announces Progress With HIV Cure Program - ABC 7 Interview with CEO Jeff Galvin
ABC 7 News Interview with Dr. Jose Bordon who Infused HIV Therapy to First Participant In Phase 1
5
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.
4
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.
Upcoming Milestones
3) First Human Efficacy
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.
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2) Phase 2 Approved
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.
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1) Phase 2 Completed
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.
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0) Biologics License Agreement (BLA)
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.
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