Source: Vaxxinity, Inc.
Vaxxinity, Inc. (Nasdaq: VAXX), a company pioneering the development of a new class of immunotherapeutic vaccines, today announced that UB-311, an anti-amyloid beta immunotherapeutic vaccine, has been granted Fast Track designation by the U.S. Food and Drug Administration (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.
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