The ancient dream of conquering aging has long been relegated to the realms of myth and alchemy. But in the 21st century, a growing cadre of scientists and entrepreneurs is reframing this quest not as a search for immortality, but as an engineering problem. The central hypothesis of this new field, known as geroscience, is that aging is the root cause of most chronic diseases that plague humanity. Instead of fighting cancer, Alzheimer’s, or heart failure one by one, what if we could target the underlying, systemic process of aging itself?
This is the foundational premise of Unlimited Bio, a biotechnology company that recently received backing from the longevity fund Immortal Dragons. Unlike traditional biotech firms that often hone in on a single drug target, Unlimited Bio operates with a radically different philosophy: aging is a consequence of the concurrent failure of multiple interconnected biological systems, and to combat it, we must address these systems simultaneously.
“In general, aging is complex, but we still don’t have enough knowledge to understand how complex it is,” admits Ivan Morgunov, the CEO of Unlimited Bio, in an exclusive interview with the Drug and Device World. “But to try to do something, we have to build a framework.”
That framework is being built not in the traditional hubs of Boston or Basel, but within the unique regulatory sandbox of Prospera, a special economic zone on the Caribbean island of Roatan. From this unconventional base, Morgunov and his team are preparing for a landmark dual-gene therapy combination clinical study in healthy individuals, planned for late 2025 to early 2026. A bold step that serves as a proof-of-concept for their ultimate goal: a comprehensive, multi-therapy protocol to rejuvenate the human body.
The Flaw with Fighting One Fire at a Time
Modern medicine is brilliantly adept at putting out fires. If you have high cholesterol, you get a statin. If you have a specific cancer, you might receive a targeted immunotherapy. This single-target, single-disease approach has saved countless lives. However, it is inherently reactive and often siloed. While one system is being treated, others continue to degrade with age, leading to new ailments.
This is because aging is not a single process. Studies have identified nine interconnected “hallmarks of aging”—including genomic instability, telomere attrition, epigenetic alterations, and loss of proteostasis. Think of a complex machine, like a car. Over time, the engine wears down, the electrical system gets faulty, the suspension weakens, and the paint corrodes. Fixing a single spark plug might solve an ignition problem, but it won’t stop the transmission from failing a year later. The human body is infinitely more complex, with its “systems”, such as muscles, brain, and immune cells, constantly communicating and influencing one another’s decline.
“The entire longevity field should go to the root cause and engineer a solution when the change is just starting to happen and slow things down there right in the beginning,” Morgunov argues. He uses a simple, powerful analogy: “You don’t wait for your engine to get broken. You just change your oil from time to time to prevent it from breaking. So, it’s easier to keep changing oils in our body and maintain it in good health using some therapies than to wait until a disease.”
This preventative, systems-level maintenance is the core of Unlimited Bio’s strategy. They are not waiting for the engine to seize – they are designing a comprehensive service plan for the entire vehicle.
From X Prize to Multi-Target Cocktails
To bring structure to the immense complexity of aging, Unlimited Bio is using competitions like the X Prize Health Span as a guiding framework. This $100 million competition challenges teams to rejuvenate elderly people by 20 years. This rejuvenation is assessed through the reversal of decline in physical, cognitive, and immune functions, with Unlimited Bio adding aesthetics, such as skin and posture. To measure “rejuvenation,” the company focuses on biological age biomarkers within each system, like VO2 max for physical function and specific memory tests for cognitive function.
“The idea is to break down each function into components and try to address these components,” Morgunov explains.
He provides an overview of their approach to sarcopenia, or age-related muscle loss. “First, you need to unlock growth,” says Morgunov, highlighting their follistatin gene therapy, which inhibits myostatin, a protein that hinders muscle growth. This allows for increased muscle mass. Next, they focus on fueling muscle growth with VEGF (vascular endothelial growth factor) gene therapy, which builds capillaries for better oxygen and nutrient supply to the muscles. Lastly, Morgunov mentions that muscle function relies on mitochondria, which degrade with age, and that Unlimited Bio has solutions in development to tackle this issue.
Morgunov states that “You need to connect the muscle. As we age, the communication between nerves and muscles at neuromuscular junctions deteriorates, weakening contraction signals, which is also a target.”
“We tried the idea to push all four buttons simultaneously. And this could have really real synergetic effects,” Morgunov says.
This multi-faceted approach to aging highlights their broader vision. For cognitive decline, they may tackle neuroinflammation, synaptic plasticity, and vascular health simultaneously. The aim is a personalized combination of therapies—cell and gene therapies, biologics, and small molecules—targeting specific aspects of aging.
Why They Had to Leave the Mainstream
Unlimited Bio’s plan is notable not only for its science but for its chosen regulatory approach. Administering multiple gene therapies to healthy individuals is seen as unacceptable by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA). The regulatory framework in these regions is designed for safety above all else, and the risk-benefit calculation for an otherwise healthy person receiving an experimental gene therapy could be viewed as unacceptably high.
Morgunov clarified that they do not do this clinical trial work in the US. Adding, “We operate in Prospera, where we can conduct clinical trials on healthy individuals combining gene therapy.” He emphasizes that Prospera isn’t lawless but features a “smart” regulatory system where commercial insurance companies act as gatekeepers instead of a single risk-averse regulator.
“To be able to start our clinical trials, we have to obtain insurance from an insurer,” he explains. “So, an insurer kind of plays the role of a regulator for us.”
The model proposed creates a better balance between safety and innovation. Traditional regulators like the FDA focus primarily on safety due to public pressure, which can hinder progress. In contrast, insurers have dual incentives: promoting innovative companies while assessing risks to avoid costly payouts. “They aim to balance safety and efficiency,” says Morgunov. Additionally, the system fosters competition, as anyone can start their own insurance company, promoting progress among regulators on Prospera.
This innovative regulatory approach is what allows Unlimited Bio’s first trial to proceed. It’s a high-stakes experiment in itself, testing whether a more agile, market-based regulatory model can accelerate breakthroughs that the conventional system would delay for decades.
The Near-Term Mission and the Year-Long Moonshot
With the backing from Immortal Dragons, Unlimited Bio’s immediate focus is its groundbreaking combination trial. Morgunov is careful to clarify what “proof-of-concept” means in this context. “By proof of concept, I mean that we as a company can run a clinical trial on a combination gene therapy operationally,” he says. It’s about proving the logistical and regulatory feasibility as much as the biological effect.
The trial will be open to applicants who meet the health criteria. Participants will receive the combination of VEGF and follistatin gene therapies for free, needing only to cover their travel to Roatan. The primary goal is to demonstrate safety and operational viability, while also tracking a suite of biomarkers related to physical and cognitive function.
But this is merely the opening act. Morgunov’s eyes are fixed on a far more ambitious milestone slated for next year: a one-year comprehensive rejuvenation program.
“We will launch our one-year program. It will be a real moonshot to regenerate a human being,” he announces with palpable excitement. “We’ll combine gene therapies and other types of interventions. It will probably be dozens of interventions.”
This program would pull together everything in their pipeline, potentially including licensed therapies from other companies, into a single, intensive protocol for a small number of individuals. It would include not just pharmaceutical interventions but also structured lifestyle components.
“I believe it will be the best, the strongest effort so far that humanity has tried to do on one or a few individuals to rejuvenate them,” Morgunov says. “It’s like trying to send the first human to space. It’s something like that that we will try to do next year.”
The Long-Term Vision
The obvious question that follows such ambition is one of accessibility. Is this a future only for the wealthy elite? Morgunov vehemently disagrees with this long-term outlook, drawing a parallel to another world-changing technology: genetic sequencing.
“The first human genome sequence cost around one to two million dollars per person, but now it can be purchased for less than 100 dollars,” he notes. “I believe gene therapies will eventually cost just a few dollars, possibly within the next 10 to 20 years.”
His vision is that complex, combination rejuvenation protocols will follow the same cost curve, evolving from an exotic, million-dollar procedure to a widely accessible form of preventative medicine. The initial trials in Prospera are the critical first step to generating the safety and efficacy data that could, over time, persuade mainstream regulators and drive down costs through manufacturing innovation and scale.
“I believe that regulation also will be changed during next 10 to 20 years and Prospera will play a role in it as a good example or sandbox,” he predicts. The data generated in this regulatory sandbox could be the catalyst that transforms how the world approaches aging, shifting the global healthcare paradigm from reactive sickness care to proactive health maintenance.
Ivan Morgunov and the team at Unlimited Bio are redefining human health by focusing on the root causes of disease, particularly age-related issues. “Most people don’t care about health until a significant problem arises,” he notes, stressing that up to 99% of diseases stem from aging.
