UB 311 is a synthetic peptide vaccine for Alzheimer’s disease being developed by United Neuroscience, a spin-off of United Biomedical.

How UB 311 works

A peptide is a short stretch of amino acids, which are the building blocks of proteins. UB 311 is composed of amino acids 1-14 in the beta amyloid protein. Toxic beta amyloid clumping in the brain is a hallmark of Alzheimer’s. The clumping leads to the nerve cell damage seen in the disease, scientists say.

The vaccine is designed to provoke an antibody response against beta amyloid, clearing it away, without triggering potentially damaging inflammation. United Biomedical used its UBITh technology to identify the peptide for the vaccine. The company packaged it in a proprietary vaccine-delivery system.

UB 311 in clinical trials

Preclinical-trial studies in small mammals, baboons, and macaques showed that the vaccine generated antibodies against beta amyloid. The antibodies were able to stop the toxicity that beta amyloid was generating, and help clear the clumps. UB 311 was also safe, and patients tolerated it well.

United Neuroscience has also been testing UB 311 in a number of trials in Taiwan.

One was a Phase 1 clinical trial (NCT00965588) of 19 patients with mild to moderate Alzheimer’s disease. The trial assessed its ability to trigger an immune response, safety and whether patients could tolerate it well. The vaccine met all three goals, results showed. The most common adverse events were injection site swelling in four patients and agitation in four patients.

Researchers also conducted an observational trial (NCT01189084) on the vaccine’s long-term effectiveness. The study, which involved 14 patients, was completed in 2011, but no results were disclosed.

United Neuroscience is continuing to conduct a Phase 2 trial (NCT02551809) evaluating UB 311’s ability to trigger an antibody response, its safety, and whether patients with mild cases of Alzheimer’s can tolerate it. This study is also assessing the vaccine’s effect on patients’ cognitive, neuropsychiatric and other functioning, including learning and memory.

Researchers presented Interim results of the trial at the 10th clinical trials on Alzheimer’s disease meeting in 2017. They showed that UB 311 generated antibodies to specific beta amyloid peptides and fibrils and there was no decrease in antibody levels in patients who were older. The findings also showed that PET imaging of beta amyloid clumps and genetic screening for the APOE4 gene, a risk factor for Alzheimer’s, can help identify people with mild cases of the disease. The final results from the trial are expected in the second half of 2018.

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