Nearly 7 million Americans, or one in nine people age 65 and older, have Alzheimer's. The number is expected to reach 13 million by 2050. The first-in-class therapeutic vaccine, Duvax, aims to prevent Alzheimer's before cognitive symptoms appear. We spoke with Roman Kniazev, biotech entrepreneur and the driving force behind the vaccine's go-to-market strategy.
Roman Kniazev, CEO of Nuravax, aims to redefine how the world views and prevents Alzheimer's. After 10 years of investing in biotech and building state-of-the-art drug development facilities worldwide, he is on a mission to protect brain health.
If Kniazev succeeds, Duvax, the first-in-class therapeutic vaccine anti-Alzheimer's vaccine, could reach the market within the next few years.
"Duvax will use validated blood-based biomarkers to detect early asymptomatic stages of Alzheimer's with accuracy similar to positron emission tomography (PET) scans, the current gold standard for diagnosing the disease due to their ability to detect brain changes," Kniazev said.
According to Kniazev, Duvax marks the beginning of personalized Alzheimer's prevention. "With accessible diagnostics and a therapeutic immune-based vaccine for preclinical Alzheimer's, we could stop the disease from progressing to clinically diagnosed, symptomatic stages and causing irreversible brain damage," he said.
Millions of people who are unaware they are at risk could benefit. More than 47 million Americans are silently accumulating pathological forms of amyloid or tau—both key hallmarks of Alzheimer's disease—despite showing no signs of memory loss or cognitive decline. Neurologists refer to this as preclinical Alzheimer's disease.
The Science of Catching Alzheimer's Early
"Recent advances in biomarker science have opened an entirely new clinical window," Kniazev said. "Several blood-based tests—some already available for consumer use—can detect toxic forms of beta-amyloid (Aβ) and tau protein."
These tests offer accuracy and specificity comparable to $8,000 to $15,000 PET scans, providing a much more convenient and affordable route to early detection.
Kniazev believes this diagnostic revolution is the missing piece needed to mainstream the Alzheimer's vaccine model.
"For the first time, regular people can identify their Alzheimer's risk with a simple blood draw—and make the decision to protect their brain before it's too late," he said. "Our vaccine is designed to be that protection."
Duvax generates therapeutic antibodies that clear pathological Aβ and tau from the bloodstream before they deposit in the brain and start killing neurons.
Uniquely, the vaccine is calibrated to induce a significantly stronger response against tau, which accumulates inside neurons and is widely regarded as the more neurotoxic target.
For years, biotech companies have struggled to achieve a higher concentration of anti-tau antibodies than anti-amyloid beta (Aβ) antibodies in a single formulation. This challenge has been a major barrier to developing an effective anti-Alzheimer's vaccine.
"The ideal product should maintain a specific ratio favoring anti-tau antibodies while ensuring neither interferes with the other's efficacy or stability," Kniazev said. "This requires a precisely engineered approach that meets strict safety standards."
Nuravax has now reached a major milestone in developing this formulation.
Built Through Persistence, Precision — and Experience
The development of Duvax was anything but straightforward. The team faced both scientific and engineering challenges in creating a vaccine that was safe, stable for storage, and, most importantly, capable of inducing a high, durable titer of preventive antibodies, without triggering immune-related toxicity.
"We went through many iterations and setbacks," Kniazev said. "It took every bit of knowledge, experience, and persistence we had to get it right. But we refused to compromise. Duvax is the result of those hard-earned lessons."
To save time and resources, Kniazev has drawn on his experience creating a state-of-the-art human blood plasma processing project in Eastern Europe. "In biotech, you can achieve the same result at different costs," he said. "During my plasma project, I saved about two billion just during the factory construction phase."
Smarter, Faster, and Long-Lasting Innovation
Duvax became possible thanks to MultiTEP, the innovation platform. The MultiTEP platform enables the vaccine to produce strong, high levels of protective antibodies in people with various genetic backgrounds.
More importantly, it does so without the safety issues linked to ARIA-E and ARIA-H conditions that can occur in Alzheimer's patients treated with certain therapies. These issues involve brain swelling and microbleeds, which can lead to serious side effects. Based on numerous animal studies, including those in nonhuman primates, Duvax has shown no signs of these risks, making it a safer alternative, according to Kniazev.
"We expect that just 2–3 intramuscular shots, followed by a simple annual booster, probably will be enough to prevent preclinical Alzheimer's patients from progressing to an official diagnosis," Kniazev said. "It's as convenient as a flu shot—just far more consequential."
Unlike many biologics that require specialized –80°C storage, Duvax is formulated to remain stable in regular refrigeration. This critical feature allows for use in standard clinical settings without the need for advanced infrastructure.
"We didn't want this to be a premium-only solution," Kniazev said. "Duvax was built for global accessibility—because Alzheimer's is a global crisis."
Nuravax has already completed cGMP manufacturing of a clinical-grade batch, clearing the way for human clinical trials.
"Duvax isn't just a vaccine," Kniazev said. "It's a disruptive model—a way for people to detect a silent threat and act before it strikes. That's the future of Alzheimer's care, and we're building it now."
If successful, Duvax could shift Alzheimer's treatment from late-stage management to early-stage prevention, significantly reducing the estimated $321 billion in healthcare costs associated with Alzheimer's treatment in the U.S. The global cost of dementia is projected to reach $2 trillion by 2030.
