Nuravax Inc., a biotechnology company specializing in immunotherapy for neurodegenerative disorders, has been awarded a $3 million grant from the National Institutes of Health (NIH) to advance Duvax, their innovative dual-target Alzheimer's vaccine, into human clinical trials. The grant was secured through NIH's highly competitive Small Business Innovation Research (SBIR) Fast-Track program, with initial funding allocated to begin Phase 1 clinical trials evaluating the vaccine's safety and immunogenicity.
The Irvine, California-based company, in partnership with the non-profit Institute for Molecular Medicine (IMM), earned top-tier scores on their first NIH grant submission—a rare achievement that underscores the scientific merit and strategic importance of the Duvax vaccine program.
Novel Dual-Target Mechanism
Duvax represents a significant advancement in Alzheimer's research as the first vaccine designed to simultaneously target both amyloid-beta and tau proteins, the two primary pathological hallmarks of Alzheimer's disease. This dual-targeting approach positions the vaccine as a potential breakthrough in preventive therapy.
"This SBIR grant is a powerful endorsement of our mission to clinically validate and advance Duvax as a first-in-class vaccine for Alzheimer's prevention," said Roman Kniazev, CEO of Nuravax. "While IMM laid the scientific foundation, our focus at Nuravax is on translating that innovation into real-world impact. This funding enables us to move Duvax into clinical trials in the U.S. and brings us one step closer to delivering it as preventive therapy for individuals at risk – before symptoms begin."
Unlike most current Alzheimer's treatments that focus on managing symptoms or modifying disease after diagnosis, Duvax is specifically designed for use during the preclinical stage—when pathological changes are occurring but before cognitive symptoms manifest. This approach aims to fundamentally shift treatment paradigms from reactive to preventive strategies.
Preventive Approach to Alzheimer's
Dr. Michael Agadjanyan, VP of IMM and Head of Immunology, emphasized the significance of this milestone: "The Phase 1 trial, supported by this SBIR grant awarded to our development and commercialization partner, Nuravax, marks a critical step in translating years of foundational research at IMM into a potential clinical breakthrough. Based on strong preclinical data, we at IMM expect Duvax to elicit a robust immune response against both Aβ and tau pathologies, an approach that could fundamentally shift the paradigm of Alzheimer's treatment."
The vaccine's implementation strategy involves using precise blood tests to detect early pathological changes, enabling identification of at-risk individuals before irreversible neurological damage occurs. By clearing toxic forms of amyloid-beta and tau proteins at this early stage, Duvax aims to prevent disease progression rather than merely treating symptoms after they appear.
Clinical Development Timeline
The initial portion of the $3 million grant will fund the Phase 1 clinical trial, with remaining funds expected later in 2025. This first human trial will evaluate both safety parameters and the vaccine's ability to generate an appropriate immune response against the targeted proteins.
The development represents a significant step forward in Alzheimer's research, particularly as the field has increasingly recognized the importance of early intervention. Current estimates indicate that pathological changes in Alzheimer's disease begin 15-20 years before clinical symptoms appear, creating a substantial window for preventive approaches.
Broader Platform Technology
The Duvax vaccine utilizes IMM's MultiTEP platform technology, which enables the development of diverse vaccine formats including DNA, RNA, and recombinant protein-based designs. This versatile platform may have applications beyond Alzheimer's disease.
Nuravax is also developing immunotherapeutic vaccines for other neurodegenerative conditions, including Parkinson's disease, traumatic brain injury (TBI), and chronic traumatic encephalopathy (CTE), all focused on early intervention strategies.
The NIH funding, awarded through the National Institute on Aging under Award Number R44AG091903, represents a significant vote of confidence in both the scientific approach and the potential clinical impact of this novel preventive vaccine strategy for Alzheimer's disease.
