Orange County, Calif. – October 07, 2026 -- The Institute for Molecular Medicine (IMM) and Nuravax have dosed the first four participants in TAURUS-1980, a Phase 1 trial testing AV-1980R, described as the world's first active immunotherapy targeting pathological tau protein linked to Alzheimer's disease.
Trial targets at-risk adults before cognitive symptoms appear
TAURUS-1980 will enroll up to 48 cognitively unimpaired adults aged 65 to 80 who have biomarker-confirmed brain amyloid pathology, a known precursor to Alzheimer's. Participants are randomized 3:1 to receive AV-1980R or placebo across three ascending-dose cohorts of 20, 60, and 180 micrograms.
Multicenter study follows subjects through Week 58
The multicenter, randomized, double-blind, placebo-controlled study administers intramuscular injections at Weeks 0, 4, and 38. The primary objective is safety and tolerability, while secondary endpoints measure anti-tau antibody and T-cell responses. Exploratory assessments include plasma Alzheimer's biomarkers, tau PET imaging, and cognitive testing.
Vaccine built on MultiTEP platform targets specific tau epitope
AV-1980R is a recombinant protein vaccine built on IMM's MultiTEP platform. It is engineered to trigger helper T-cell responses that drive B-cell production of antibodies against an N-terminal tau epitope encompassing the phosphatase-activating domain, a region implicated in tau's pathological spread.
NIH grant of $24.5 million backs the program
The trial is sponsored by IMM and supported by a $24.5 million grant from the National Institute on Aging, part of the National Institutes of Health, under program AG092924. It operates under FDA Investigational New Drug application 29644 and is registered at ClinicalTrials.gov as NCT07158905.
Researcher calls study a focused safety test ahead of larger trials
"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. He noted that if results support further development, later trials could test effects on biomarkers and clinical progression.
Michael G. Agadjanyan, Ph.D., contact principal investigator of the NIH-supported program and professor of Immunology at IMM, said dosing the sentinel cohort marks an important clinical milestone for AV-1980R and the MultiTEP platform. He added that safety and immunogenicity data from TAURUS-1980 are intended to guide the design of larger proof-of-concept preventive efficacy studies in at-risk individuals.
Nuravax, an IMM spinout, holds an exclusive license covering AV-1980R and the broader MultiTEP-based neurodegenerative vaccine portfolio and is pursuing strategic development and commercialization partnerships.