Oragenics Announces Positive Data on Their Intranasal SARS-CoV-2 Vaccine Candidate in a Posted Preprint Manuscript
March 03 2022 - 9:09AM
Business Wire
Intranasal Immunization Lowers the Viral Load
Below the Limit of Detection in Lungs of Hamsters
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) today announced the posting of a preprint manuscript
in bioRxiv (pronounced “bio-archives”). The manuscript, co-authored
by Oragenics and its collaborators at Inspirevax and the National
Research Council of Canada (the “NRC”) Human Health Research
Centre, is titled “Intranasal Immunization with a
Proteosome-Adjuvanted SARS-CoV2 Spike Protein-Based Vaccine is
Immunogenic and Efficacious in Mice & Hamsters.” The preprint
is available here https://doi.org/10.1101/2022.03.02.482651.
The studies described in the manuscript evaluated a novel spike
protein subunit vaccine formulation, NT-CoV2-1, containing a
proteosome-based mucosal adjuvant designed for intranasal
immunization. The studies concluded that intranasal formulation
induced robust antigen-specific IgG and IgA titers in the blood and
lungs of mice. In addition, the formulation was highly efficacious
in a hamster challenge model, reducing the viral load below the
limit of detection of the assay. In both mice and hamsters, the
antibodies had strong neutralizing activity, preventing the
cellular binding of the viral spike protein based on the ancestral
reference strain and variants of concern. The studies concluded
that this intranasal vaccine formulation warrants further
development as a novel SARS-CoV-2 vaccine.
“Intranasally delivered SARS-CoV-2 vaccines could provide
increased protection in the nose and throat where viral entry
occurs. This could lead to lower transmission of the virus compared
to the currently available intramuscularly delivered vaccines as
well as offering a needle-free delivery option. We believe the
results from these studies continue to support the development of
our intranasal vaccine. The findings from this second preclinical
study will be a part of our Investigational New Drug filing to the
U.S. Food and Drug Administration (the 'FDA'), and should
facilitate advancement of the program into human clinical studies,”
said Frederick W. Telling, Ph.D., Executive Chairman of
Oragenics.
About Oragenics, Inc.
Oragenics, Inc. is a development-stage company dedicated to
fighting infectious diseases including coronaviruses and
multidrug-resistant organisms. Its lead product is an intranasal
immunization vaccine candidate to prevent COVID-19 and variants of
the SARS-CoV-2 virus. The vaccine program leverages coronavirus
spike protein research licensed from the National Institute of
Health and the NRC with a focus on reducing viral transmission and
offering a more patient-friendly intranasal administration. Its
lantibiotics program features a novel class of antibiotics against
bacteria that have developed resistance.
Forward-Looking Statements
This communication contains “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements are based on management’s beliefs and assumptions and
information currently available. The words "believe," "expect,"
"anticipate," "intend," "estimate," "project" and similar
expressions that do not relate solely to historical matters
identify forward-looking statements. Investors should be cautious
in relying on forward-looking statements because they are subject
to a variety of risks, uncertainties, and other factors that could
cause actual results to differ materially from those expressed in
any such forward-looking statements. These factors include, but are
not limited to, the following: the Company’s ability to advance the
development of its vaccine candidate and lantibiotics candidate
under the timelines and in accord with the milestones it projects;
the Company’s ability to obtain funding, non-dilutive or otherwise,
for the development of the vaccine and lantibiotic product
candidates, whether through its own cash on hand, or another
alternative source; the regulatory application process, research
and development stages, and future clinical data and analysis
relating to vaccines and lantibiotics, including any meetings,
decisions by regulatory authorities, such as the FDA and
investigational review boards, whether favorable or unfavorable;
the potential application of our vaccine candidate to variants and
other coronaviruses; the Company’s ability to obtain, maintain and
enforce necessary patent and other intellectual property
protection; the nature of competition and development relating to
COVID-19 immunization and therapeutic treatments and demand for
vaccines and antibiotics; the Company’s expectations as to
administration, manufacturing, storage and distribution; other
potential adverse impacts due to the global COVID-19 pandemic, such
as delays in regulatory review, interruptions to manufacturers and
supply chains, adverse impacts on healthcare systems and disruption
of the global economy; and general economic and market conditions
and risks, as well as other uncertainties described in our filings
with the U.S. Securities and Exchange Commission. All information
set forth in this press release is as of the date hereof. You
should consider these factors in evaluating the forward-looking
statements included in this press release and not place undue
reliance on such statements. We do not assume any obligation to
publicly provide revisions or updates to any forward-looking
statements, whether as a result of new information, future
developments or otherwise, should circumstances change, except as
otherwise required by law.
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Oragenics, Inc. Michael Sullivan, Chief Financial Officer
813-286-7900 msullivan@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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