The HIV epidemic has raged for over four decades and to date, there is no widely available cure. However, in rare cases, people living with HIV have been cured. The first cure was declared in 2008, the second in 2019, and then two more in 2022 and another in 2023. These cases shatter the notion that HIV is permanent and incurable, but the invasive procedures used to install rare donor cells render these methods unfeasible for mass use. To liberate the millions of people living with HIV, we need a safe, scalable method to cure HIV – which is where Addimmune comes in.
Addimmune was formed by American Gene Technologies® (AGT™) after AGT103-T, a gene and cell therapy for HIV, demonstrated encouraging Phase 1 clinical trial results. AGT103-T was designed to be what researchers call a functional cure, which is a therapy that enables recipients to control HIV without the help of antiretroviral medication. After AGT103-T established momentum in initial clinical testing, Addimmune was formed to advance the HIV cure program further. With dedicated investment and a singular focus on HIV, the Addimmune team will facilitate the smoothest possible path through clinical testing and hopefully to commercialization.
So far, AGT103-T has been tested in a Phase 1 clinical trial, and no serious adverse events were reported during the trial: a great initial safety profile. An additional study, called the Durable Anti-Retroviral Withdrawal Initiative (DARWIN), was initiated after the Phase 1 trial to study the impact of AGT103-T in the body when antiretroviral medication was paused. All DARWIN participants showed an immune response against HIV, more than half have already shown significant viral suppression, and further data continues to be generated from the study. The Phase 1 trial and the DARWIN trial have provided ample information to optimize the use of this first-in-class intervention in later-stage clinical trials. Imbued with hope and excitement, the Addimmune team plans to add to the momentum with a Phase 2 study.
A cure for HIV, and an end to the devastating, expensive, decades-long HIV epidemic is more than just a noble cause. The business case is sound, the technology is here, and the societal impact is enormous. Addimmune builds on over a decade of work done by American Gene™, making it the frontrunner in the race to the cure in terms of clinical progress. We are Addimmune and with revolutionary gene therapy technology, we believe a cure for HIV is possible.