Vaccine maker Vaxxinity has just received the FDA’s fast-track designation for its candidate Alzheimer’s vaccine, UB-311.
Vaccines are one of the greatest medical advances in history, and now, this strategy is being applied to the treatment and prevention of Alzheimer’s. Currently, there are at least nine different Alzheimer’s vaccines in trials, and one of them has just been fast-tracked by the Food and Drug Administration, which means that while its FDA approval is not guaranteed, its review process will be expedited.
Vaxxinity is developing a new class of immunotherapeutic vaccines, and today the company announced that their vaccine UB-311 — an anti-amyloid immunotherapeutic vaccine being designed for people with Alzheimer’s disease — has been granted Fast Track designation.
Does Vaxxinity’s Alzheimer’s vaccine work?
UB-311 is an immunotherapeutic vaccine candidate. It targets one of Alzheimer’s main biomarkers: toxic forms of aggregated amyloid protein in the brain. Its Phase 1, Phase 2a, and Phase 2a Long Term Extension trials have shown it to be well tolerated in people living with mild to moderate Alzheimer’s over three years of repeat dosing.
Is this Alzheimer’s vaccine safe?
Trials are still ongoing. But according to the trial data so far, the vaccine’s safety profile appears to be comparable to placebo and no cases of amyloid-related imaging abnormalities-edema (ARIA-E) in the main study — a differentiator from the only disease-modifying Alzheimer’s drug on the market, Aduhelm (the efficacy of which has been called into question).
What’s next for Alzheimer’s vaccine UB-311?
UB-311 also elicited robust and durable anti-amyloid beta antibody responses in patients, according to Vaxxinity. The company plans to initiate a Phase 2b trial in late 2022. From there, if the vaccine continues to prove safe and effective, it will go on to Phase 3 trials. When the trial process is complete, the FDA will review all the data and determine whether the vaccine can be approved and made publicly available.
“We are excited that the FDA has granted UB-311 Fast Track Designation, as it recognizes the evidence demonstrating the potential for UB-311 to address a serious unmet medical need for patients with Alzheimer’s disease,” Mei Mei Hu, Chief Executive Officer of Vaxxinity said in a press release. “We are on an encouraging clinical path for UB-311 and look forward to collaborating with the FDA and other global regulatory agencies to bring UB-311 expeditiously to the global market.”
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs intended to treat serious or life-threatening conditions, with evidence demonstrating the potential to address an unmet medical need. The designation will allow Vaxxinity more frequent engagement with the FDA to discuss development plans and the design of proposed clinical trials to ensure appropriate data collection to support drug approval processes.
“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,” Hu said.