Raj Natarajan, host of ShareTreck, goes behind the scenes with Jeff Galvin, Founder and CEO of American Gene™ in this compelling interview learn how gene therapy works, and what it means for people with deadly diseases, as well as how it will impact the current pharmaceutical landscape. The company is currently in the midst of a human clinical trial using gene therapy to find a potential cure for HIV. Find out what’s on the horizon and when investors might see a public offering. Watch the full video to find out what’s on the horizon for the company, or read on for key takeaways from their conversation.
American Gene™ is currently conducting their first in-human Phase I study to test the safety and level of efficacy of a potential cure for HIV. Preliminary results are encouraging and the company expects to have additional data by the end of 2022.
“HIV is not even as hard to clear as a cold or the flu, once you can restore normal immune response to the virus. That's what we did with our product, and our initial Phase I shows that the immune system is acting the way that it's supposed to.”
- Seven patients have received AGT103-T and have experienced no serious adverse events, thereby demonstrating the therapy’s safety.
- So far, the data has confirmed that the cells are properly engrafting, persisting, and seem to be remaining uninfected while reacting to, and likely fighting HIV the way scientists expected.
- American Gene has begun withdrawing participants from their antiretroviral drugs, which will ultimately reveal whether they are cured of HIV, meaning they no longer need daily medication, and can’t develop AIDS or become re-infected with HIV.
- The company expects to reveal the results of the ATI by the end of this year (2022).
American Gene’s potential HIV cure is built from a platform with reusable components. This platform then creates the foundation to cure other diseases.
“What's really exciting about [AGT103-T] is not just that we may be able to provide hope for many people that have been diagnosed with HIV, but if we're successful in that, we'll take that money and reinvest it, and we can cure a whole bunch of other chronic viral infections.”
- American Gene’s platform provides a framework of tools that can be transferred to the treatment and cure of other diseases. Gene and cell therapy allows for accurate treatment delivery to infected cells, while avoiding healthy tissue. Once that framework is established, it can be modified to target other other diseases, eliminating the need to reinvent the wheel, and eventually reducing costs.
- “I look at us as being the Microsoft of this new software for the organic computer,” explains Jeff Galvin. “I think we’ve got the MS-DOS for your body right now, but we’re going to turn that into the iPhone for your body, where curing diseases is like writing an app, because the platform does so much of the heavy lifting.”
“I think we can reduce cancers to an infusion or a shot in the arm one day, and we can send radiation and chemotherapy the way of bloodletting and leeches. I am a hundred percent confident of that.”
American Gene plans to launch a separate company dedicated to HIV early next year, with an eye towards taking that company public.
- Spinning off the HIV component into a public company will allocate more resources toward Phases II and III of the clinical trial, while allowing American Gene to remain private and nimble to continue developing their platform.
- Phase I data from AGT103-T is expected to be submitted to the FDA for approval in February. Pending FDA acceptance, it will move into Phase II.
- Phase II will treat fifty to one hundred patients, which should be enough to show efficacy. At that point, the company may apply for a limited license to allow the new spinoff company to begin commercializing their product.
“No gene and cell therapy really fails because you keep debugging it and debugging it, and eventually you get it. The risk will come down to almost zero and the industry will explode with cures. There are 10,000 diseases and only about 500 cures out there today. I think gene and cell therapy may cover the rest of them.”