Researchers at the University of New Mexico (UNM) are preparing to launch a phase 1 trial for a vaccine candidate designed to elicit an immune response against pathological tau protein – a hallmark of Alzheimer’s disease.
The vaccine, developed by a team led by neuroscientist Kiran Bhaskar, is based on virus-like particles (VLPs) that display phosphorylated tau peptides. In preclinical studies, the vaccine triggered robust antibody responses in mouse models and nonhuman primates, and appeared to reduce tau accumulation in the brain without eliciting significant adverse effects.
With the support of a $1 million “Part the Cloud” grant from the Alzheimer’s Association, the team will begin the double-blind, placebo-controlled phase 1a/1b study in early 2026. The trial will evaluate safety, tolerability, and immunogenicity in patients with early-stage Alzheimer’s disease, under the oversight of Janice Knoefel at the UNM Center for Memory & Aging.
Unlike recent immunotherapies that target amyloid-beta, the vaccine candidate focuses on hyperphosphorylated tau – specifically the pT181 epitope. Tau pathology is thought to correlate more closely with cognitive decline. According to a statement from UNM, “In a normal brain, the tau protein stabilizes the microtubules that form the ‘skeleton’ of neurons. But when it undergoes a process called phosphorylation, it is ejected from neurons, creating tangles that are characteristic of Alzheimer’s and other neurodegenerative diseases.”
The vaccine was created by attaching pT181 to a VLP platform and will be manufactured under GMP conditions by the Canadian biotech TheraVac Biologics, which holds the licensing rights.
If the trial establishes a favorable safety and immunogenicity profile, the team plans to pursue further clinical development, including larger studies to assess potential disease-modifying effects.
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