Vaxxinity Receives FDA Fast Track Designation for UB-311 for Treatment of Alzheimer’s Disease

Vaxxinity, Inc. recently announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted Fast Track designation by the US FDA for the treatment of Alzheimer’s disease.

“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,” said Mei Mei Hu, Chief Executive Officer of Vaxxinity. “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. 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.”

The 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. A Fast Track designation allows for 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.

Alzheimer’s disease (AD), the most common form of dementia, is a progressive neurodegenerative disorder that slowly destroys memory and cognitive skills and eventually the ability to carry out simple tasks. Its symptoms include cognitive dysfunction, memory abnormalities, progressive impairment in activities of daily living and a host of other behavioral and neuropsychiatric symptoms. The exact cause of AD is unknown, but genetic and environmental factors are established contributors. Accumulation of the amyloid beta peptide is a key component of AD pathophysiology with current evidence supporting the hypothesis that amyloid beta deposits in the brain contribute to disease progression. AD affects more than six million people in the United States and 44 million worldwide. The economic burden of AD is expected to surpass $2.8 trillion by 2030.

UB-311 is an immunotherapeutic vaccine candidate targeting toxic forms of aggregated amyloid beta in the brain to treat Alzheimer’s disease. Phase 1, Phase 2a, and Phase 2a Long Term Extension trials have shown UB-311 to be well tolerated in mild-to-moderate AD patients over three years of repeat dosing, with a safety profile comparable to placebo and no cases of amyloid-related imaging abnormalities-edema (ARIA-E) in the main study. UB-311 also elicited robust and durable anti-amyloid beta antibody responses in patients. A Phase 2b trial is expected to be initiated in late 2022.

Vaxxinity, Inc. is a purpose-driven biotechnology company committed to democratizing healthcare across the globe. The company is pioneering a new class of synthetic, peptide-based immunotherapeutic vaccines aimed at disrupting the existing treatment paradigm for chronic disease, increasingly dominated by monoclonal antibodies, which suffer from prohibitive costs and cumbersome administration. The company’s proprietary technology platform has enabled the innovation of novel pipeline candidates designed to bring the efficiency of vaccines to the treatment of chronic diseases, including Alzheimer’s, Parkinson’s, migraine, and hypercholesterolemia. The technology is also implemented as part of a COVID-19 vaccine program. Vaxxinity has optimized its pipeline to achieve a potentially historic, global impact on human health.