Vaxxinity vaccine to treat Alzheimer’s disease wins FDA fast-track designation

It’s been a promising month for Vaxxinity, the Dallas biotech company testing a new wave of vaccines to treat chronic diseases.

The company announced on Monday that its candidate vaccine to treat Alzheimer’s disease, called UB-311, has received fast-track designation from the Food and Drug Administration, which will speed up the review process through more frequent discussions between Vaxxinity and the Federal Regulatory Agency.

A few days earlier, the company had completed enrollment in the latest clinical trial of its vaccine to slow the progression of Parkinson’s disease. The Phase 1 Part B trial for the vaccine, known as UB-312, will dose its first Parkinson’s patients in the Netherlands after a successful Part A trial in healthy participants.

This string of successes for Vaxxinity, which also began a Phase 3 trial for a COVID-19 booster candidate in April, lends some credence to the company’s immunotherapeutic vaccine platform that targets diseases that have long eluded to treatment.

It’s a level of rapid progress that Vaxxinity CEO Mei Mei Hu is taking one day at a time.

“If you’re in the business of transformation and disruption, it’s half exhilarating and half nerve-wracking, but it’s part of the journey,” she said. “It’s not easy to do something really disruptive, so I’m just excited that right now we’re [moving] One step forward.”

Following the mission to “democratize health” by providing cheaper and more convenient therapies for chronic diseases, Vaxxinity formed in 2021 with the combination of Covaxx of Dublin and United Neuroscience of Dallas.

The company is trying to use synthetic peptides – molecules that can mimic proteins – to create vaccine therapies for a wide range of diseases, including Alzheimer’s disease, Parkinson’s disease and migraines.

Its candidate UB-311 for Alzheimer’s disease has already passed phase 1 and the first part of phase 2 trials, showing that the vaccine is well tolerated in participating patients, which helped to obtain the accelerated designation of the vaccine. . The accelerated program exists to address “unmet medical needs” for serious conditions, such as with the rapid development of COVID-19 vaccines.

Now that UB-311 has fast-track designation, Vaxxinity is eligible for more frequent communication with the FDA regarding data collection and proposed clinical trials. Such a label must be requested by the drug company and then reviewed by the FDA, according to the agency’s website.

The designation only refers to an increased speed of the approval process, not an increased likelihood of success, said Dr. Hana El Sahly, professor of molecular virology and microbiology at Baylor College of Medicine.

In the case of COVID-19 vaccines, “regulators and sponsors were sharing data and reviews in a timely manner, but they didn’t know in advance if the vaccines were going to be safe and effective,” she said. . “The same goes for any product. Until the data is presented and reviewed, it is still unknown.

UB-311 targets toxic forms of the beta-amyloid peptide that accumulate as plaques in the brains of people with Alzheimer’s disease and are thought to contribute to disease progression. The vaccine is one of several beta-amyloid treatments currently vying for federal approval.

Only one disease-modifying drug, called aducanumab, has been approved by the FDA to treat the disease, although it is still being studied to determine its effectiveness over time. It also targets beta-amyloid.

“This should be great news, but there is no strong evidence that removing amyloid plaques improves clinical symptoms of the disease,” said Erin Abner, associate professor in the University’s Department of Epidemiology. of Kentucky and a researcher at the University of Alzheimer’s disease. Center for Disease Research.

Additionally, about four in 10 patients who receive the treatment develop a brain inflammation called amyloid-related imaging abnormalities, which involves bleeding and swelling in the brain, according to the University’s Center for Memory and Aging. from California to San Francisco.

Patients who received UB-311 showed no evidence of such brain inflammation, Vaxxinity said.

The company also battles Parkinson’s disease, another neurodegenerative disease that progressively affects body movement. Vaxxinity’s UB-312 targets malformed versions of a protein in the brain, called alpha-synuclein, to slow Parkinson’s disease and other conditions such as dementia with Lewy bodies and multiple system atrophy.

A Phase 1 Part A study of the vaccine has already yielded results, published in the journal Movement Disorders, that suggest the treatment was well tolerated by healthy participants who volunteered for the trial. The Phase 1 Part B trial will administer the vaccine to 20 patients with Parkinson’s disease for the first time, with initial results expected by the end of the year.

As part of the Part B trial, Vaxxinity will also partner with the Mayo Clinic and the University of Texas to study biomarkers that could aid in the future treatment of Parkinson’s disease with a grant from the Foundation. Michael J. Fox for Parkinson’s disease research. Vaxxinity declined to disclose the amount of the grant or the cost of the Phase 1, Part B study.

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