UB-311 is an immunotherapy vaccine made by Vaxxinity that helps target and prevent Alzheimer’s disease. The vaccine focuses on getting the body to clean up amyloid-beta proteins that are toxic through a reaction of the immune system. Immunotherapy stimulates a response of the immune system so it does its job.
Amyloid-beta is a protein that occurs naturally in healthy brains but forms clumps or tangles between the brain cells of people with Alzheimer’s disease. This causes cellular death that leads to Alzheimer’s symptoms. The vaccine aims to help patients with mild to moderate symptoms. The goal of this treatment is to “improve cognitive function”.
Currently, there are 9 vaccines in clinical trials for the treatment of Alzheimer’s disease. UB-311 is the only to receive an acceleration in approval by the FDA. Accelerated approval only means the results from the clinical trials will be reviewed more rapidly. It is not an indicator of efficacy.
UB-311 works at the biological (cellular) level to target harmful clumps of protein in the brain and clean them up. This is done by stimulating a response from the immune system. Helper T-cells are activated with the vaccine and forces the immune system to do its job. This doesn’t mean that it is fixing the immune system; the medication is helping it respond properly. The immune system is able to target harmful amyloid-beta proteins. These complex proteins are a sign of Alzheimer’s and build up as the disease progresses. The removal of the dying brain cells helps improve cognitive function.
UB-311 claims it will help Alzheimer’s patients with many basic functions: logic, understanding, remembering, and interpreting information. These are all tested via different Alzheimer’s disease assessment scales that are testing cognitive improvement like Mini-Mental State Exam (used to measure severity of thinking problems caused by Alzheimer’s). So far, the vaccine is proven to be safe. This has been shown through clinical studies that followed patients for 3 years. The most common side effects were irritation where the injection was given and agitation.
Studies show that UB-311 causes a reaction by the immune system targeting amyloid beta protein tangles and reducing them. To date, UB-311 has completed over 3 years of studying patients. It has completed Phases 1, 2a and 2a extension. With this much data, the FDA designated UB-311 a “fast track designation”. That was because of its safe results that are medically beneficial. Accelerated approval is for drugs that can help with serious illnesses but also need to be studied more.
Phase 1 found that by giving 3 injections 4 weeks apart for 3 months, all patients showed an immune system response almost a year later. They had safe reactions to the vaccines, finding irritation at the injection site and agitation as the side effects.
Phase 2a observed patients for 78 weeks who were given 2 different doses of injections and boosters (2 shot and 3 boosters vs. 3 shots and 4 boosters) or a placebo. Its goal was testing the safety of the vaccine and if after long usage the immune system was able to be triggered to create a response. Additionally, cognitive functions were tested. The study was successful, and the participants were asked if they wanted to continue the trial over a longer period of time.
Phase 2a Extension studied UB-311 for 108 weeks. Participants were given either a placebo or doses of either 3 or 5 vaccines. Proving that good amyloid beta proteins were being created to clean up the bad ones, 96% of patients showed good results with little side effects.
Phase 2b is planned to start in late 2022. It will enroll 670 Alzheimer’s patients to make sure the drug is producing good antibodies that help clean up the harmful clumps.
Phase 3 does not have a start date but will administer 3 vaccines and 4 boosters to a larger test group of 3,218 patients. This is the final phase before FDA approval. It will continue to have to prove its safety while also trying to address if it can reduce the effects of Alzheimer’s in the brain.
To date, UB-311 has proven safe in all its clinical trials. Also, after testing patients’ scores on the Mini-Mental State Exam showed improvement compared to those who took a placebo. Brain scans showed a reduction in amyloid beta protein.
It is estimated that if the trials of UB-311 continue to prove its medical benefit we could see this drug on the market in the next 5 years. First, UB-311 must complete Phase 3 which can take up to 4 years then seek FDA approval.