American Gene Technologies has officially completed its Phase 1 clinical trial for AGT103-T and submitted its final report to the FDA. Data about this first-in-human study was published in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement.
No trial participants experienced any serious adverse events. The modified T cells engrafted, expanded after infusion and maintained reactivity to HIV in 100% of the trial participants. There was no rejection of the cells, which were detectable in patients, even without exposure to the virus, until the last measurement at 180 days. There were no observable differences in safety between the low-dose and high-dose gene therapy.
After completing the Phase 1 human trial, we conducted a sponsor-initiated study called “Durable Anti-Retroviral Withdrawal Initiative (DARWIN)” with approval from the Independent Review Board (IRB) and our clinical trial investigators to test the therapy’s efficacy after cessation of patients’ antiretroviral treatment. Despite non-ideal conditions in the DARWIN study, we still measured impressive viral and immunological data in participants in the absence of their usual antiretroviral medication. 100% of the participants showed active immune responses to HIV, and the data showed that more than half of the participants achieved significant viral suppression.
We have submitted the final Phase 1 trial report to the FDA. Our scientists continue to analyze the data to fully understand the mechanisms underlying these findings. All of these encouraging results give us optimism that we’re at an inflection point in our efforts to cure HIV.
We are now designing the Phase 2 clinical trial protocol and working to identify manufacturers and trial sites. As we review the Phase 1 data with potential collaborators and partners, the response has been consistently enthusiastic to participate in the Phase 2.
The Phase 2 clinical trial is expected to optimize the regimen and then treat 50 to 100 patients to demonstrate efficacy. We expect to discuss the Phase 2 with the FDA and hope to initiate the trial in 2024.