Nuravax, Inc. and the Institute for Molecular Medicine (IMM) have announced the publication of Phase 1 clinical trial results for AV-1959R, an investigational amyloid-beta (Aβ) vaccine designed to target pathological forms of amyloid-beta associated with Alzheimer’s disease. The findings were published in Molecular Neurodegeneration in July 2026.

The randomized, double-blind, placebo-controlled trial evaluated the vaccine’s safety and immunogenicity in non-cognitively impaired participants.

Key Findings from the Phase 1 Trial

The study enrolled 16 participants, with 12 receiving AV-1959R and four receiving a placebo. According to the published results, the trial met its safety and immunogenicity objectives.

Key findings include:

• Antibody response: All 12 participants who received AV-1959R developed anti-amyloid-beta antibody responses after two priming immunizations administered one month apart.

• Antibody titers: Geometric mean titers (GMTs) reached 60,240 in the 100 µg cohort and 69,530 in the 300 µg cohort.

• Placebo comparison: No measurable antibody response was observed in the four placebo recipients, whose anti-Aβ42 antibody levels remained at baseline.

• Target recognition: Exploratory analyses showed stronger antibody binding to aggregated amyloid-beta species, including protofibrils and fibrils, with weaker binding to oligomers and little to no binding to monomeric Aβ.

• Amyloid plaque binding: Serum from vaccinated participants bound amyloid plaques in cortical tissue from Alzheimer's disease cases but not in control tissue from individuals without Alzheimer's disease.

The findings provide preliminary evidence that AV-1959R can stimulate an immune response targeting aggregated forms of amyloid-beta. However, the Phase 1 study was not designed to demonstrate clinical efficacy or establish the vaccine’s safety for broader use.

Antibody Durability and Potential Booster Strategy

Antibody-kinetics modeling projected that antibody titers could remain approximately five times above baseline for around one year after the initial immunizations.

These projections support further investigation of an annual booster strategy. However, the duration of the antibody response and its clinical relevance must be confirmed in future prospective studies.

Dr. Michael Agadjanyan, head of Molecular Immunology at IMM and founder of Nuravax, stated that the results provide clinical evidence that the MultiTEP platform can help overcome immune tolerance and generate antibodies that preferentially recognize aggregated amyloid-beta.

Planned Phase 2 Trial of AV-1959R

Nuravax and IMM plan to advance AV-1959R into a Phase 2 trial focused on preventive treatment in individuals with confirmed amyloid pathology.

The planned study aims to:

• Enroll cognitively unimpaired individuals with biomarker-confirmed amyloid pathology.

• Include participants with both low and high amyloid burdens.

• Expand safety monitoring to include amyloid-related imaging abnormalities involving hemorrhage (ARIA-H) and edema (ARIA-E).

• Evaluate surrogate efficacy measures using amyloid- and tau-related biomarkers in the brain and blood.

According to Lon S. Schneider, professor of psychiatry, neurology and gerontology at the Keck School of Medicine of USC and a co-author of the publication, the Phase 1 study provides an initial assessment of safety and immunogenicity. The planned Phase 2 trial is intended to investigate these questions further in participants with confirmed amyloid pathology.

About AV-1959R

AV-1959R is an investigational amyloid-beta vaccine based on the MultiTEP platform. It is designed to stimulate antibody responses against pathological forms of amyloid-beta in individuals with evidence of amyloid pathology who may be at risk of developing Alzheimer's disease.

The vaccine uses a strategy intended to generate an immune response against disease-associated proteins while addressing the immune system’s natural tolerance to self-proteins.

AV-1959R is not approved for any use, and its safety and efficacy have not been established.

About the MultiTEP Platform

The MultiTEP platform was developed by the Institute for Molecular Medicine over more than two decades. It combines self-antigen B-cell epitopes with foreign T-helper epitopes to stimulate antibody responses against proteins that the immune system would otherwise tolerate.

Nuravax is developing vaccine candidates based on this platform for neurodegenerative diseases involving amyloid-beta, tau and alpha-synuclein.

About Nuravax, Inc.

Nuravax, Inc. is a clinical-stage biotechnology company based in Irvine, California. The company develops vaccines for neurodegenerative diseases and originated as a spin-off of the non-profit Institute for Molecular Medicine.

Nuravax licenses the MultiTEP vaccine platform for its development programs targeting proteins associated with neurodegenerative conditions.

About the Institute for Molecular Medicine

The Institute for Molecular Medicine is a non-profit biomedical research organization based in Huntington Beach, California. IMM developed the MultiTEP platform and supplied the AV-1959R drug product under the NIH cooperative program U01 AG060965.

Publication and Clinical Trial Details

Publication: Hovakimyan A., Madoyan H., Najarzadeh Z., et al. “A randomized, placebo-controlled, double blind Phase 1 trial of the Aβ vaccine, AV-1959R, in non-cognitively impaired participants: prelude for secondary preventive therapy in preclinical AD.”

Journal: Molecular Neurodegeneration, July 2026.

Read the full publication: https://link.springer.com/article/10.1186/s13024-026-00980-y

Clinical trial registrations:

• ANZCTR: ACTRN12624000737538

• ClinicalTrials.gov: NCT06831812

Clinical significance: The Phase 1 results support further investigation of AV-1959R as a potential preventive vaccine for Alzheimer’s disease. Larger clinical studies will be needed to determine whether the observed antibody responses translate into meaningful clinical benefits and to establish the vaccine’s safety profile.