Interim report: Nuravax's Alzheimer’s vaccine AV-1959R found safe, immunogenic in all healthy volunteers.
Nuravax Inc.
Nuravax’s Alzheimer’s vaccine AV-1959R is safe, triggered strong immune responses in all Phase 1 trial participants, showing promise for disease prevention.
IRVINE, CA, UNITED STATES, June 12, 2025 /EINPresswire.com/ -- Nuravax Inc., a biotechnology company specializing in active immunotherapy for neurodegenerative disorders, received promising preliminary clinical data from its placebo-controlled, double-blind Phase 1 trial of AV-1959R. The amyloid-beta (Aβ) adjuvanted vaccine is based on its universal MultiTEP platform technology, licensed from the non-profit Institute for Molecular Medicine (IMM).
No serious adverse events (SAEs) have been reported, and MRI scans show no signs of ARIA-E (edema) or ARIA-H (microhemorrhages) in all vaccinated and placebo people.
“Initial results on immunogenicity are highly encouraging, with very strong antibody responses meeting our expectations based on the study's active-to-placebo allocation, said Roman Kniazev, CEO of Nuravax. “Achieving a 100% responder rate and an excellent safety profile so far in this Phase 1 trial is a significant milestone. This safe and immunogenic vaccine has full potential in Phase 2 to demonstrate its ability to prevent the onset of Alzheimer’s disease in vaccinated cognitively unimpaired individuals who are at risk for the disease.”
This initial human data from a MultiTEP®-based AV-1959R vaccine highlights the platform’s strong potential, which also supports other Nuravax’s preventive vaccine candidates for neurodegenerative disorders currently under development.
The MultiTEP technology, licensed from IMM, is designed to activate non-harmful T helper cell responses that trigger humoral immunity and stimulate the production of antibodies. These antibodies help reduce or prevent the accumulation of aggregated Aβ, which initiates Alzheimer's disease pathophysiology.
“Preclinical results and clinical data with monoclonal antibodies, Leqembi®, Kisunla™ suggest that a safe and immunogenic Aβ vaccine may inhibit the accumulation of pathological amyloid, potentially delaying the onset of Alzheimer’s in cognitively unimpaired individuals at risk of disease,” said Dr. Michael Agadjanyan, VP of IMM. "These early findings suggest that after the completion of Nuravax’s Phase 1 trial, this AV-1959R vaccine would be a prime candidate for primary and secondary preventive therapy for individuals at risk of Alzheimer’s.”
These encouraging early results also reflect the impact of a carefully developed manufacturing strategy that preserves the antigen’s structure. This process is critical for inducing high-titer, target-specific, and functional antibodies, an essential factor in achieving effective immune engagement in the context of Alzheimer’s disease prevention.
About Nuravax
Nuravax Inc. is a clinical-stage biotech company developing and advancing immunotherapeutic vaccines for neurodegenerative diseases, including Alzheimer's, Parkinson's, TBI, and CTE. Focused on early intervention, Nuravax aims to alter disease progression before irreversible damage occurs. In addition to AV-1959R, the company’s portfolio of Alzheimer’s prevention vaccines includes AV-1980R and Duvax.
About IMM
The Institute for Molecular Medicine (IMM) is a non-profit research organization dedicated to understanding, preventing, and curing chronic human diseases, with a focus on neurodegeneration. IMM is advancing MultiTEP — a universal vaccine platform technology that enables the development of diverse vaccine formats, including DNA, RNA, and recombinant protein-based designs.
Victoria Zavyalova
V Startup Agency
vic@vstargency.com
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