The Biotech Project podcast hosts Scott J Resnik, MBA, NYS EMT-CC, and John Walsh, MD, sit down with American Gene Technologies® founder and CEO Jeff Galvin for a lively and inspiring discussion.Watch the full episode to follow Jeff’s journey as he builds a company that’s on a path toward revolutionizing the traditional approach to treating diseases by daring to aim for cures. Here are some key takeaways from the conversation.
American Gene™ sees gene and cell therapy as a new powerful technology that is opening up solutions to terrible diseases that were untreatable or unaddressable in the past, and that will — in Jeff’s words — send radiation and chemotherapy the way of bloodletting and leeches.
“We're modifying DNA, which could be looked at as the operating system of the human cell, and now that we can correct errors in that operating system or we can improve that operating system, the question is: What can't we do?”
- That was the epiphany Jeff had when he met Dr. Roscoe Brady at NIH and learned about the potential of viral vectors.
- Jeff saw that revelation as the beginning of an opportunity to cure pretty much everything.
- For Jeff, that mind-blowing vision was simply too exciting not to get involved in, which launched him into forming and building AGT™.
American Gene’s Phase 1 HIV cure clinical trial is underway. People think a Phase 1 trial is just about demonstrating safety. But that’s not correct.
“Because gene therapy is so powerful, the FDA doesn't let you test it until you've already theoretically proven its safety. So, then you have a very small Phase 1 on people that have the disease. We're actually getting efficacy data in the Phase 1, and we're still recording the results of an analytic treatment interruption to see how effective this was in seven people that had HIV.”
- The goal is to make a functional cure that’s a single-infusion treatment so patients never have to worry about HIV for the rest of their lives: They won’t have to take any pills or medication. They won’t be contagious. They can't get AIDS or contract HIV again.
- In American Gene’s Phase 1 HIV cure trial trial, every single patient has shown therapeutic effect so far. The trial isn’t over the functional cure line yet, but the data is still coming in.
- The Phase 1 trial could still result in some functional cures, but either way the company is getting a lot of data indicating exactly what it needs to change. The next time it runs a study, Jeff believes they’re likely to see some of those functional cures.
Gene therapy is a fundamentally different approach to medicine and to treating disease. Rather than producing a drug that sends molecules all over the body, treating every cell the same, gene therapy uses targeted viruses that only infect targeted cells.
“The [viral vector] carries little software components that act like if/then switches. They're called specific promoters, and they decide whether to turn the drug on based on an enzyme or protein that's inside the cell… So, this is obviously a whole different ball game in the drug development world in general.”
- This approach makes progress much more predictable and will ultimately lower the cost of curing monogenic diseases.
- AGT’s platform could be used to deliver a therapy to the right cells in a targeted, safe manner, at expression levels that are sufficient.
- Jeff believes that as development of AGT’s platform continues, as more and more features are added, developing new cures will become faster, cheaper, and more reliable.
Resnik and Walsh asked Jeff what gets him started each day and keeps him going.
“The day that I met Roscoe Brady and I realized — oh my gosh — if this can be done, it must be done. So, what I do makes a difference. This is why I'm passionate. And I think everybody in my company feels the same way.”
- American Gene sees gene therapy as the path for curing thousands of diseases. And Jeff sees that same belief across the entire industry, that it's the future of pharmaceuticals.
- From Jeff’s vantage point, it's easy to be excited. At American Gene, he empowers people to apply their raw intelligence, their self-discipline, their work ethic and — the secret sauce — their passion, to AGT’s mission.
- He recalls the Margaret Mead quote: “Never doubt the ability of a small team to change the world. It's seldom anyone else that does.” He believes you just need a critical mass of those folks to start a revolution — hence the excitement at American Gene Technologies and throughout the industry.
How can people get a job at American Gene?
“We hire in everything. The amazing thing about gene therapy is, we're doing stuff that's never been done before. So, it's not like we can hire experienced people. In fact, some kinds of experience can even hold you back, because your prior work got you so entrenched in the existing model that you don't realize you can break free and create a new way of doing things.”
- Go to americangene.com and apply — even if there's not a specific job listed that catches your eye. The company is always looking for hardworking, passionate people.
- Not all AGT jobs focus on science. It takes a variety of skill sets and talents to make a company like American Gene not only successful, but great.
- If you are somebody who can think outside of the box, if you're in love with the vision and you believe like American Gene does that this is where the world is going, just send in your resume and explain why you want to work in this industry.