Dallas-based biotechnology innovator Vaxxinity has announced that its Alzheimer’s vaccine, UB-311, has received a “fast track” designation from the FDA.
The FDA’s “fast track” process allows for drugs to be approved faster due to an “unmet medical need.” The expedited FDA approval comes over 10 years after the first UB-311 trial was conducted in 2011.
UB-311 is an immunotherapeutic vaccine that, contrary to typical vaccines, is administrated after someone falls ill with a disease. These types of vaccines are popular in treating cancer and are developed using monoclonal antibodies, DNA, or existing cells from a patient.
UB-311 is a synthetic peptide vaccine, which uses amino acids to trigger a response from the body. The amino acids cause the body to fight against clumps of beta-amyloid proteins in the brain, which are believed to be a hallmark of Alzheimer’s disease.
In 2011, the first human trials began in Taiwan with nineteen elderly diagnosed with mild Alzheimers. Further trials suggested that the vaccine was effective in fighting against the clumps of beta-amyloid proteins.
The researchers, United Neuroscience, determined in 2019 that the vaccine had a 96% rate of antibody production, an indication that the vaccine is working correctly. This phase, dubbed “2a,” had met the companies’ “primary aims of safety and immunogenicity,” per Newswire.
“Because our vaccine approach allows for more convenient administration and broad access, UB-311 is positioned to potentially lead a paradigm shift in the treatment, and even prevention, of Alzheimer’s,” stated Mei Mei Hu, chief executive officer of Vaxxinity.
Vaxxinity has many vaccines in development, including for Parkinson’s and COVID-19. Only the COVID-19 booster has entered the third phase of testing, but the fast track by the FDA should allow UB-311 to enter the final stages as well.