Addimmune will build upon the success of American Gene Technologies Phase 1 HIV clinical trial, accelerating the clinical development with dedicated investment and singular focus on HIV.

ROCKVILLE, Md., June 9, 2023 /PRNewswire-PRWeb/ -- American Gene Technologies (AGT™), a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company — Addimmune — to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.

Addimmune aims to create tremendous benefits for HIV patients, payers, and the public. Its gene therapy technology has the power to transform millions of lives. The new company's name represents a fusion of two fundamental concepts: using gene and cell therapy to add new capacity to the human T cell to create an improved immune system to fight HIV.

Addimmune is founded on the solid legacy established by AGT.

• Spinning off the HIV components into a separate company enables Addimmune to focus its resources on the Phase 2 and Phase 3 clinical trials.
• The Phase 2 clinical trial will optimize the regimen for an expanded trial, treating fifty to one hundred patients with the intention to firmly establish efficacy levels that justify a pivotal study. If successful, upcoming additional clinical trials could allow Addimmune to continue towards commercialization and the goal of providing improved outcomes and quality of life for people living with HIV.

"I founded American Gene Technologies fifteen years ago in the wake of the Human Genome Project, inspired by scientific discoveries in viral vectors and other technological advancements in gene and cell therapy. I saw a future where modifying DNA would lead to treatments and cures for formerly intractable diseases. Fast forward to today, our HIV clinical trial has produced a successful Phase 1 for our single-infusion gene therapy, AGT103-T. Now we're launching a new company, Addimmune, to accelerate our research and continue to pursue our mission to cure HIV. We feel the market is receptive to this mission, data, and potential. Additional capital and a laser focus on HIV will align our company with the hopes and needs of the HIV community and maximize our chance of success," explained American Gene Technologies CEO, Jeff Galvin.

American Gene completed the Phase 1 HIV clinical trial and submitted the final report to the U.S. Food and Drug Administration (FDA). Internal data from the HIV Phase 1 clinical trial demonstrated the following results:

• 100% of the participants experienced no serious adverse events.
• 100% of the participants' modified T cells were engrafted, expanded after infusion, and maintained reactivity to HIV.
• There was no rejection of the cells that continued to be detected in patients, even without exposure to the virus, until final study measurements at 180 days.
• There were no differences in safety between the low-dose and high-dose treatment arms.

Data about this first-in-human study was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement.

After completing the Phase 1 human trial, American Gene Technologies conducted a sponsor-initiated study with approval from the Independent Review Board (IRB) and clinical trial investigators to test the therapy's efficacy after cessation of patients' antiretroviral treatment.

Despite the relatively long time between the infusion of the HIV cure cell therapy and the analytic treatment interruption study, AGT still measured impressive viral and immunological data in participants absent the typically prescribed antiretroviral treatment drugs:

• 100% of the participants showed active immune responses to HIV.
• The data showed that more than half of the participants achieved significant viral suppression.

AGT scientists continue to analyze the data to fully understand the mechanisms underlying these findings.

About Addimmune
Addimmune was founded in 2023 to cure HIV with promising gene therapy technologies. Building upon the success of American Gene Technologies' HIV clinical trial, Addimmune is solely focused on developing and commercializing an effective and lasting cure for HIV. Learn more about Addimmune in this video: https://www.youtube.com/watch?v=xFQVfUtiYQc

About American Gene Technologies
American Gene Technologies is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of gene therapies to cure infectious diseases, cancers, and inherited disorders. Its mission is to transform people's lives through genetic medicines that rid the body of disease. Safety data from American Gene Technologies' Phase 1 HIV gene therapy clinical trial is published in the Frontiers in Medicine journal. In addition, the company has been granted broad patent protection for the technology used to make AGT103-T. Numerous other patents have been granted for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors, as well as other important innovations and discoveries that are useful across a wide variety of gene and cell therapy applications. American Gene Technologies has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. The company's treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2025.

Media Contact

Kathy Fowler, American Gene Technologies, 410-963-2345, kfowler@americangene.com

SOURCE American Gene Technologies