Vaxxinity Receives FDA Fast Track Designation for UB-311 for Treatment of Alzheimer’s Disease
May 02 2022 - 7:00AM
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.
About Alzheimer’s DiseaseAlzheimer’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.
About UB-311UB-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.
About VaxxinityVaxxinity, 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.
Forward-looking StatementThis press release
includes forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. The use of
certain words, including "believe," "may," “continue,” “advancing,”
“aim,” “strive,” “intend,” "will" and similar expressions, are
intended to identify forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties, including statements that are based on the current
expectations and assumptions of Vaxxinity’s management about the
development of a new class of immunotherapeutic vaccines, the
potential outcome and findings of clinical trials for UB-311 and
the innovation and efficacy of Vaxxinity’s product candidates.
Various important factors could cause actual results or events to
differ materially from those that may be expressed or implied by
our forward-looking statements. Additional important factors to be
considered in connection with forward-looking statements are
described in the "Risk Factors" section of the Company's Annual
Report on Form 10-K filed with the Securities and Exchange
Commission on March 24, 2022. The forward-looking statements are
made as of this date and Vaxxinity does not undertake any
obligation to update any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Investor ContactClaudia
Styslingervaxxinity@argotpartners.com
Press ContactKaren
Chasekaren.chase@westwicke.com
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