Collage of photos of AGT employees, scientists in the lab, and the AGT office building
BioBuzz by Workforce Genetics

​​HIV Functional Cure Momentum Builds as American Gene Technologies Approaches Data Readout

American Gene Technologies, a clinical-stage biotechnology company located in Rockville, Maryland, is one of the many exciting and promising companies that call the BioHealth Capital Region (BHCR) home.

After achieving several important clinical milestones, momentum and excitement have been building for months around the company’s lead pipeline candidate AGT103-T, which is a potential HIV functional cure. In the coming months, the company expects to have the latest data readout for its Phase 1 trial. AGT103-T is a single-dose HIV gene therapy that could potentially replace antiretroviral therapy (ART) with a functional cure.

American Gene Technologies has been making steady clinical trial progress as the team strives to pull their HIV cure program to the finish line. 

In November 2021, the company announced that the independent Data Safety and Monitoring Board (DSMB) overseeing American Gene Technologies’ RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258) found no serious adverse events (SAEs) from the treatment of its third patient. The DSMB also voted unanimously to allow the organization’s HIV cure program to continue at a faster pace. 

Then in February 2022 the company announced the safe and effective dosing of two more clinical trial patients.   

Most recently, the company broke news that five of the six clinical trial patients (data is still pending on the sixth patient) who received AGT103-T had demonstrated safety and blood markers of efficacy. There have been no serious adverse events in the Phase 1 study. These promising results prompted the Institutional Review Board (IRB) overseeing the trial to approve analytic treatment interruption (ATI) of the patients’ ART program to potentially demonstrate American Gene Technologies’ functional HIV cure.

“This is a very exciting and hope-filled time for the HIV community and for our company,” stated Jeff Galvin, American Gene Technologies’ Founder and CEO. 

“Once these patients stop ART, there’s the possibility of a viral rebound within a month. The upcoming data readout will tell us if our HIV gene therapy prevents this rebound from happening. We’re actively working to develop protocols for taking patients off of ART safely and we’ll soon have the opportunity to review the treatment interruption data If one patient stays in remission off of ART that would be groundbreaking. If all patients remain in remission, we would have clear visibility to a functional cure for HIV for millions of people living with HIV,” added Galvin. 

This cascade of positive HIV cure program data—as well as American Gene Technologies’ efforts to educate stakeholders about HIV and its potential cure via programs like The Cure Chronicles—has garnered tremendous interest and sparked tangible excitement among HIV advocate communities, leading scientific experts and investors. The interest building behind American Gene Technologies’ HIV cure program has also attracted some of the leading scientific experts to the company’s fight to cure HIV. 

Most recently, Dr. Jeff Boyle, formerly the President of Ellume USA LLC, was announced as the company’s new Chief Science Officer.   

In addition, American Gene Technologies’ HIV advisory team now includes life sciences veterans Dr. W. David Hardy of Johns Hopkins University, Dr. Ely Benaim and John J. Rossi, PhD. The company also recently named Dr. Marcus A. Conant as Chief Medical Officer; Conant is a leading U.S. dermatologist who was one of the first physicians to diagnose and treat AIDS.  

The company’s professional advisors also include former Secretary of the Department of Health and Human Services Tommy Thompson and Dr. Robert Redfield, the former director for the CDC. 

We spoke with a  few of the company’s investors, who recognized AGT103-T’s enormous potential not only to eliminate the profound burden of ART by possibly curing HIV, but also as a positive and disruptive force in the drug development industry.  

In late April 2022 American Gene Technologies announced that Ride Wave Ventures had invested in the company, bringing its fundraising total to nearly $60M. Ride Wave Ventures targets high growth startups with the potential for venture class returns. This capital will go directly to supporting American Gene Technologies’ HIV cure program as well as the development of gene therapies for some of humanity’s worst diseases, including cancers and phenylketonuria (PKU).

The enthusiasm, hope, expertise, and investment interest enveloping American Gene Technologies’ HIV cure program is a result of the aforementioned clinical trial milestones and its educational outreach. 

However, it’s critical to not lose sight of why this progress has been made and why so much momentum is building around this HIV cure program—the leading-edge science behind AGT103-T.

American Gene Technologies’ technology platform utilizes viral vectors as its primary therapy delivery system. The company’s potential functional cure is an autologous gene therapy (where cells are removed from a patient, stored and processed outside the body, and then returned to that same patient) that infuses HIV patients with their own supercharged CD4 T cells. CD4 T cells, or helper T cells, are critical to fighting off infection; however, HIV targets and destroys helper T cells to a level where they can no longer combat the HIV infection. AGT103-T CD4 T cells are both trained to detect HIV-specific proteins and are genetically modified using lentiviral vectors to prevent HIV from entering and multiplying, meaning that they are resistant to being infected by the very virus they are seeking to destroy.

American Gene Technologies is attempting to develop a single infusion of enriched, HIV-specific CD4 T cells that will resist HIV infection/destruction, allowing the body to fight the infection and create durable immunity. AGT103-T is a potential “functional” cure because it doesn’t eradicate HIV entirely from the body but recruits the immune system to durably suppress the virus to prevent AIDS or passing the disease to others. It may also render the individual permanently immune to HIV, preventing the possibility of reinfection.

Since the advent of successful ART, which has helped improve the lives of those living with HIV, public perception of HIV/AIDS has transformed from abject terror to wrongly believing the disease has been “cured” and that the disease’s global impact is insignificant. This perception is simply wrong. While contracting HIV is no longer a death sentence, its global impact on public health and HIV patients is still profound. 

I-270-Wet-Lab-Frederick-Maryland

According to the World Health Organization (WHO), over 79M people have been infected with HIV and over 36M people have died from AIDS since the epidemic began. In 2020, over 37M people were living with HIV and some 680,000 died of AIDS-related illnesses

What’s more, as of June 2020, 28.2M people are estimated to be receiving daily ART globally. While one of the greatest achievements in medical history, ART and subsequent treatment forms do not cure HIV. Within just weeks of stopping treatment, the virus returns to full strength and chronic inflammation caused by suppressed HIV can lead to adverse health effects over the long term. Current HIV treatments control it but do not cure it; in fact, research shows that those being treated for HIV are more susceptible to other diseases and health risks at an earlier age.

This makes the single dose nature of AGT103-T critically important because HIV patients on daily ART therapy have to remain on this drug cocktail for life. As soon as they stop, the latent HIV reservoir will return. Treatments like AGT103-T have the promise to offer a single dose therapy that cures HIV and potentially removes the burden of lifetime ART—and its long term health risks—from patients.

While American Gene Technologies’ potential cure for HIV has been in the spotlight recently, and rightfully so, the company is also advancing a robust and diverse product pipeline to achieve its mission. American Gene Technologies’ mission is clear—to end as much human suffering as possible—yet the possible pathways to achieve this goal are manifold. The company’s gene technology platform also has strong potential to create new, effective, and safe therapies for other infectious diseases, monogenic disorders, and cancer.  

And this is what all of the excitement is about: the confluence of great science, hard working scientists, support teams and the collective will of the HIV community yielding a potential HIV cure that could improve the quality of life for millions upon millions of people across the globe.American Gene Technologies’ HIV cure program is leading the way in the company’s fight to end human suffering. Stay tuned.