Addimmune is a company that is changing the way that HIV is treated. With the company’s pioneering gene therapy approach, Addimmune believes HIV will no longer be a life-long sentence – but a curable illness. Pulse 2.0 interviewed Addimmune CEO Jeff Galvin to learn more about the company.
Jeff Galvin’s Background
Jeff Galvin. Photo Credit: Natalie Ferguson 2023
Galvin became fascinated by computers as a seventh grader back in the early 1970s. And Galvin said:
“Those early computers were my first exposure to an industry that would eventually change all of our lives. Even then, what resonated with me was the idea that we were only scratching the surface of the technology’s true capabilities. I firmly believed that computers would help us eliminate repetitive tasks and exponentially improve human productivity. By the time I was in high school, I had fully dedicated myself to the idea that computing would shape my career. I started teaching at MIT on weekends and continued to teach undergraduate classes and tutor others in computer science throughout my time as an undergraduate student at Harvard. Teaching allowed me to share my enthusiasm for the power of computer technology and created an exciting, growing, and sustainable first career.”
“After completing my degree in economics from Harvard in 1981, I spent most of the next 20+ years working in Silicon Valley, as the future of computers, software, IT, internet, and apps were being developed. Across three decades, I was able to be a part of bringing my childhood visions to life, creating and selling the technologies that dramatically altered the way people, and even whole societies, were able to function. Whether it was my early days at Apple, or the series of startup companies that followed, I witnessed first-hand how innovation swiftly transformed societies. After several of my companies were taken public or acquired, including one in the medical-technology arena that was sold to Varian, I retired early in 2001 and became an angel investor in real estate and high tech.”
“What I didn’t realize at the time was that another technology in drug development would capture my attention and inspire me to jump in with both feet to a second career. In 2007, I had a opportunity to meet Dr. Roscoe Brady, a prominent researcher at the National Institutes of Health in Maryland. During that discussion, Dr. Brady explained the potential of the emerging cell and gene therapy field. I was so excited by the potential for using viral vectors to edit genes as a path toward curing diseases that I relocated to Maryland and founded American Gene Technologies (AGT). Fifteen years later, AGT is still here, actively developing clinical-stage cell and gene therapy candidates, with the hope of delivering treatments that could potentially cure a wide range of human diseases.”
Formation Of Addimmune
How did the idea for Addimmune come together? Galvin shared:
“It’s a two-part story. In 2007, I received a business plan for a project at the National Institutes of Health (NIH) that was seeking funding, so I jumped on a plane and headed to Maryland where I met Roscoe Brady, MD, PhD.”
“Dr. Brady showed me how you can use viral vectors to edit a cell’s DNA, which in turn creates opportunities to potentially develop gene and cell therapies for a variety of diseases. That discussion inspired me to embrace a new vision for the future of human health. One with the potential to use gene and cell therapy to address monogenic diseases (disorders caused by the inheritance of single gene mutations) and even create opportunities to develop potential functional cures for chronic diseases and cancers. So, I moved my family and home to Maryland, and used my retirement nest egg to fund the launch of American Gene Technologies in 2008. Fast forward 15 years: We completed a Phase Ia human trial of our gene and cell therapy candidate AGT103-T, which we hope will potentially provide a functional cure for HIV.”
Deal With 10X Capital
Back in August, it was revealed that Addimmune is expected to become a publicly traded company following a merger with 10X Capital Venture Acquisition Corp. III, a special purpose acquisition company (SPAC). So I asked Galvin about how the deal came together. Galvin replied:
“10X Capital has been a minority investor in American Gene Technologies since January 2021, and they’ve been continuing to support our progress. While Addimmune is unique among other 10X targets, which primarily focus on software as a service (SaaS) and AI technology, we share the same bold ambition for developing disruptive technologies that benefit the lives of people around the world. So, as we looked for the best paths to continue our pursuit to end the HIV epidemic, 10X agreed that our strong history of progress and growing team of experts was the ideal fit for both organizations. We are thankful for their partnership and the expertise 10X brings regarding capital markets and the innovation that drives our continuing development of AGT103-T as a potential single-dose treatment for people living with HIV.”
Favorite Memory
What has been your favorite memory working for the company so far? Galvin reflected:
“For me, it is a culmination of all the moments we’ve experienced over the past 15 years. We set out not just to advance one therapeutic modality or even treat a specific disease, but instead, we dreamed of a world where we revolutionized what is possible in health care. Like any lofty ambition, our path has not been without challenges, but despite the temporary hurdles we’ve overcome along the way, what truly stands out for me is how our organization’s mission remained steadfast and how, one critical milestone at a time, I’ve seen my vision come to life.”
“On this incredible journey, it’s hard to pinpoint a single favorite memory. I can say that witnessing our team’s unwavering dedication to our mission to cure HIV has been the most rewarding aspect of my tenure. From my earliest conversation with Dr. Brady, when the concept of using gene therapy was still generally being met with skepticism, to where we are today, on the cusp of groundbreaking treatments and therapies, it’s been a remarkable transformation.”
“But beyond that, it’s the daily interactions with our talented and passionate team members, the scientists, researchers, patients, and everyone else who has joined us on this mission, that have created countless cherished memories. Whether in the lab, during brainstorming sessions, or simply sharing the excitement of scientific breakthroughs, these moments reaffirm the enduring spirit of our vision and our unwavering commitment to improving the lives of people around the world to make possible what is seemingly impossible.”
Challenges Faced
What challenges has Galvin faced in building the company, and has the current macroeconomic climate affected your company? Galvin acknowledged:
“The process of developing any form of technological innovation is never linear, and that applies even more so within biotech. Our understanding of human disease and overarching human biology is rapidly expanding, and with each passing day, our team is better able to understand the complex set of variables that we must overcome to potentially provide new mechanisms to counteract human disease. In the past 15 years, we have faced a number of technological challenges and rapidly changing market dynamics, but at no point have we allowed those moments to attenuate our energy or cloud our vision of what gene and cell therapy could mean. Our diverse expertise yields the synergy required to create a functional cure for one of the world’s most devastating illnesses.”
Core Products
What are the company’s core products and features? Galvin explained:
“Addimmune is laser-focused on ending the HIV epidemic and delivering life-changing therapies to the 39 million people around the globe who are living with HIV. The Phase I study results of AGT103-T were so impressive that we were compelled to create a company exclusively dedicated to the pursuit of a functional cure for HIV. As we pioneer this new era, we build upon the learnings of a legendary team. We are actively engaging with regulators and clinicians to pursue additional studies to understand the potential of AGT103-T to revolutionize HIV treatment. Our ultimate ambition is to deliver a gene and cell therapy with the potential to serve as a functional cure for HIV, by enabling patients’ immune systems to achieve durable suppression of viral replication to non-contagious levels. We think that a cure is essential for freeing people living with HIV. While we have come a long way in battling the fear, stigma, and hopelessness that defined the HIV epidemic in the 1980s and 1990s, our work is far from over. The devastation caused by HIV continues to endure, and advancement is critical for individual quality of life and to limit societal costs of the continuing HIV epidemic.”
Evolution Of Addimmune’s Technology
How has the company’s technology evolved since launching? Galvin noted:
“In the 15 years since its launch, AGT has developed a proprietary platform to help deliver a robust pipeline of promising therapeutic candidates for conditions ranging from HIV to cancer and phenylketonuria (PKU). The emergence of the company’s lead asset, AGT103-T, as a possible functional cure for people living with HIV, led the team to prioritize our HIV research, and in 2022, AGT demonstrated the safety and promising immune response of AGT103-T in our U.S. Phase I study.”
“We hope our HIV research serves as an eventual proof of concept for extending the AGT platform’s utility into new therapeutic areas. The company intends to use its platform of reusable gene and cell therapy development tools as a way to potentially reduce the time and cost of developing disease-modifying therapies by over 90% from current standards — thus powering a new business model of using gene and cell therapy to develop affordable, effective treatments for a wide range of infectious diseases, monogenic disorders, and cancers.”
Significant Milestones
What have been some of the company’s most significant milestones? Galvin cited:
“From a clinical perspective, we completed our Phase Ia HIV clinical trial of AGT103-T and submitted the final report to the U.S. Food and Drug Administration (FDA). Data about this first-in-human study was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal. Our published data showed:
— No serious adverse events.
— 100% of the participants’ modified T cells were engrafted, expanded after infusion, and maintained reactivity to HIV.
— The engrafted cells persisted and 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.”
“Additionally, we recently shared the pre-print of our follow-on analytic treatment interuption (ATI) study, which evaluated the impact on HIV-specific immune responses in AGT103-T infused patients following the cesation of antiretroviral therpay (ART). What we found was that following a second ATI, the CD 8 immune response was either maintained or rose and the peak viremia, the presence of virus levels in the blood, was substantially decreased in all study participants.”
“While there is still more to learn about AGT103-T’s therapeutic potential, as an organization, we are encouraged by the results to date and remain dedicated to pioneering cell and gene therapy candidates with the potential to suppress and hopefully durably control the virus.”
Funding/Revenue
After asking Galvin about the company’s funding and revenue information, he revealed:
“The proposed transaction represents a pre-money enterprise value of $500 million for Addimmune. The transaction includes an earnout of up to $300 million tied to various clinical and price-based milestones. Existing Addimmune stockholders will roll 100% of their equity into shares of the combined company. 10X III and Addimmune signed a non-binding LOI with Cantor for a $50 million committed equity facility. We expect the business combination transaction to close in the first half of 2024.”
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Galvin assessed:
“We believe current gene and cell therapies are just the beginning of a revolution in human health. According to Goldman Sachs, the gene and cell therapy industry could become $5 Trillion (nearly 4X the size of the current pharmaceutical market). The current cost of HIV treatment in the U.S. averages $1.7 million per person over their lifetime. This includes the cost of suppressive therapies and collateral medical services due to monitoring and treatment of the side effects of long exposures to antiretroviral therapeutics and chronic viremia. We believe that improved therapeutics with lower toxicities and more convenience, or a one-and-done functional cure if we can achieve that endpoint, is a substantial market.”
Differentiation From The Competition
What differentiates the company from its competition? Galvin affirmed:
“Addimmune is leading the search for a potential gene and cell therapy-based functional cure for HIV. Our ongoing clinical development reflects our commitment to our novel lentiviral vector approach, which we believe could enable modified T cells to work within a patient’s immune system to durably suppress HIV at nontransmittable levels.”
“Since our approach is to improve the immune system to control viremia at levels where no further treatment is necessary, it does not require that viral reservoirs be reduced to zero. This is a contrast with ‘sterilizing cures’ that would necessitate that every copy of HIV in the patient be eliminated (since even a few remaining copies could reconstitute the infection). Addimmune’s immuno-regulatory approach attempts to durably suppress any activity of the viral reservoir at levels where it is equivalent to a cure, without requiring a ‘perfect’ ridding of integrated copies of HIV that could be nearly anywhere in the body.”
Future Company Goals
What are some of the company’s future company goals? Galvin concluded:
“Addimmune is focused on delivering the world’s first single-dose functional cure for HIV to support long-term remission, prevent the virus from progressing, and liberate people from the burden of continuous treatment. There are many hurdles we will need to overcome as we work toward that goal, but we don’t plan on stopping until we achieve it.”
