In Conversation: Jeff Boyle, Chief Science Officer at American Gene Technologies

Momentum and excitement continue to build around Rockville, Maryland’s American Gene Technologies HIV cure program.

The company recently announced that it has removed trial participants from their Antiretroviral Therapy (ART) regiment, which is a major milestone for the HIV cure program. The company expects an important data readout towards the end of 2022 that will show if its HIV therapy AGT103-T is safe and effective.

What’s more, American Gene Technologies recently named Dr. Jeff Boyle as its new Chief Science Officer. Boyle was previously President at Ellume USA where he led the build out of the company’s 180,000 square foot manufacturing facility in Frederick, Maryland that produces the first COVID-19 home self-test to receive an EUA from the FDA.

Boyle is a life sciences industry veteran with deep experience in scaling businesses as well as vaccine and biologics R&D. Prior to his successful tenure at Ellume, he was at QIAGEN for over a decade where his tenure there culminated as the Global Head of QIAGEN’s QuantiFERON franchise.

We caught up with Boyle just a short time after he joined American Gene Technologies to discuss his career, why he chose to join the company, and why there’s so much excitement around its HIV cure program and pipeline.     

Tell us about your career journey and how you came to join American Gene Technologies.

I am an immunologist by training and I started in vaccine-related research. Later, I moved into biologics. Then, while I was working in the vaccines space, I got into diagnostics when the company I worked for launched a spinout diagnostics company based on technology used in our vaccine development programs.

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I stayed in research-related positions and moved up into business management positions eventually to my role leading the QuantiFERON franchise at QIAGEN. I’ve helped bring a number of products to market.

I joined Ellume in 2021 as the company’s President and helped stand up the new diagnostics manufacturing facility in Frederick, Maryland with funding secured from the Department of Defense. It was during that process that I met Jeff Galvin, American Gene Technologies’ CEO, and got to know him and the company.

Why did you decide to join American Gene Technologies?

I started in vaccine and biologics development and my PhD was in DNA vaccination, so I’ve always had an interest in gene therapy. It is a very exciting field. Immunotherapy and gene therapy are core interests of mine and listening to Jeff speak about the company’s vision, the HIV cure program, expanding into cancer, and its focus on therapies for monogenic disorders, I saw this as a great opportunity to get back to my R&D roots in these therapeutic areas.

This is something that I’ve done before—building core capabilities and scaling an organization. I did this with the diagnostics startup and also at Ellume, where I helped build the company’s U.S. business from the ground up.

American Gene Technologies is in a similar stage where we can leverage what we’ve learned about HIV and other therapeutic areas to scale the organization and advance a deep pipeline. My predecessor did an enormous amount of great work and had moved on to other challenges. I was fortunate that Jeff Galvin and the team thought I was the right fit.

American Gene Technologies’ pipeline and technology are frontier stuff and will be an inspiring challenge to execute; I’m excited about building the team and infrastructure that can bring these potential therapies to market.

What are your near-term goals for American Gene Technologies as its new CSO?

We are all laser focused on the HIV Cure Program and our ongoing clinical trial, which is at an incredibly important point right now. We’ve reached a critical step in our mission to cure HIV with gene therapy; withdrawing clinical trial participants from their antiretrovirals. So far, the data has confirmed the cells are properly engrafting, persisting, and seem to be reacting to HIV the way we expected. We hope to be able to share important data from that trial by the end of 2022.

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Beyond that, I will also focus on getting our next therapy into the clinic. We have a number of candidates in the pipeline so we will need to assess and prioritize these candidates to see which one moves ahead first.

You’ve just recently been brought onboard as CSO. What’s it been like getting to know the team and the company’s culture so far?

Jeff Galvin’s passion for the mission just permeates the entire organization. Everyone has been very welcoming; it’s been great. We have a great leadership team. Everyone is very excited about where we are and where we are headed. There’s just a big sense of possibility and potential across the organization right now.

The leadership team and advisory board are fantastic resources for me and our whole team. We’ve got some pretty heavy hitters in HIV like Dr. Marcus Conant and other experts on the advisory team. There’s been a long history in HIV research that’s now being leveraged in our HIV cure program. This HIV trial is creating so much genuine interest and excitement to see what’s next. We’re all super excited to do anything we can to make an HIV cure a reality.

We have the same passion about our other therapeutic areas and we’re just as excited about their potential as well. Our lead program and most critical focus right now is on curing HIV. However, we just received a substantial infusion of cash, so we will be able to put some more fuel behind monogenic diseases and immuno-oncology. I’m currently building teams to drive those areas and refine our platform technologies with the goal of bringing them to the clinic.

If AGT103-T gets approved, demand for it will be significant given it is a single-dose therapy that could potentially remove the need for ART altogether. What are some of the commercialization challenges that you and the team will need to work through now in preparation for a possible approval?

The infrastructure that’s required to deliver gene therapies doesn’t exist at the scale that will be required. Companies like Kite Pharma and others are building facilities to deliver these cell and gene therapies at scale. I had this experience at Ellume where we had to scale the production and delivery of COVID-19 testing kits rapidly. Understanding the challenges of bringing biotech manufacturing facilities online is an ongoing discussion internally.

By scaling manufacturing of AGT103-T, we can potentially make an HIV cure available to everyone. ART at one time was hard to come by for those suffering with HIV, but advances in manufacturing and distribution changed that to a great degree and now many patients have access to ART that didn’t when the treatment first hit the market.

That’s the goal with our potential HIV cure, to be able to scale manufacturing so this cure is available to all who need it. That’s our mission and we aim to complete it.