Groundbreaking randomized study will evaluate safety, tolerability, and immune responses to the investigational preventive tau vaccine in up to 48 cognitively unimpaired individuals with confirmed brain amyloid pathology who are at risk of Alzheimer's.
ORANGE COUNTY, Calif., Oct. 7, 2026 /PRNewswire/ -- The Institute for Molecular Medicine (IMM) and Nuravax today announced that the first four participants have been dosed in TAURUS-1980, a Phase 1 trial of AV-1980R. This is the world's first active immunotherapy targeting pathological tau, whose accumulation in the brain correlates with all stages of Alzheimer's disease.
AV-1980R is a recombinant protein vaccine based on IMM 's universal MultiTEP platform. It is designed to generate helper T-cell responses to non-self MultiTEP epitopes that support B-cell production of antibodies against an N-terminal tau epitope encompassing the phosphatase-activating domain (PAD).
TAURUS-1980 is a multicenter, randomized, double-blind, placebo-controlled, multiple-dose-escalation study. Up to 48 cognitively unimpaired adults aged 65 to 80 with biomarker evidence of amyloid pathology will be randomized 3:1 to AV-1980R or placebo across three ascending-dose cohorts of 20 micrograms, 60 micrograms, and 180 micrograms. Participants receive intramuscular injections at Weeks 0, 4, 38, and are followed through Week 58. The primary objective is safety and tolerability; secondary objectives assess anti-tau antibody and T-cell responses. Exploratory assessments include plasma Alzheimer disease biomarkers, tau PET imaging, and cognitive measures.
"This study asks a focused Phase 1 question: can active tau vaccination be given safely and generate the intended immune response before cognitive symptoms emerge?" said Lon S. Schneider, M.D., a principal investigator at the Keck School of Medicine of USC. "To our knowledge, TAURUS-1980 is the first clinical study of an active tau vaccine in preclinical Alzheimer's disease. If the results support further development, later trials can test effects on biomarkers and clinical progression."
IMM sponsors the trial, which is supported by the National Institute on Aging (NIA), part of the National Institutes of Health (NIH), through a $24.5 million grant program AG092924. The study is being conducted under U.S. Food and Drug Administration Investigational New Drug application (IND) 29644 and is registered at ClinicalTrials.gov as NCT07158905.
"Dosing the sentinel cohort marks an important clinical milestone for AV-1980R and the MultiTEP platform," said Michael G. Agadjanyan, Ph.D., contact principal investigator of the NIH-supported program, professor of Immunology at IMM, and co-inventor of AV-1980R. "The safety and immunogenicity data from TAURUS-1980 are intended to guide the design of larger proof-of-concept preventive efficacy studies in preclinical Alzheimer's disease individuals who are at risk of dementia."
About the Institute for Molecular Medicine
The Institute for Molecular Medicine is a nonprofit biomedical research institute developing vaccines and immunotherapies for neurodegenerative diseases and other age-related disorders. IMM developed AV-1980R and the MultiTEP platform and sponsors TAURUS-1980 in collaboration with academic and clinical research partners.
About Nuravax
Nuravax is an IMM spinout biotechnology company advancing active immunotherapies for neurodegenerative diseases. Nuravax holds an exclusive license from IMM covering AV-1980R and the broader MultiTEP-based neurodegenerative vaccine portfolio and is pursuing strategic development and commercialization partnerships. For more information, visit www.nuravax.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding the development and potential of AV-1980R and the MultiTEP platform. Such statements involve risks and uncertainties, and actual results may differ materially from those expressed or implied. AV-1980R is investigational: its safety and efficacy have not been established, and the U.S. Food and Drug Administration or any other regulatory authority has not approved it.
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SOURCE Institute for Molecular Medicine
