Oragenics Announces Favorable Preliminary Toxicology Data for Intranasal COVID-19 Vaccine Candidate
24 Août 2022 - 1:00PM
Business Wire
- N T-CoV2-1 preliminary data supports regulatory
filings for Phase 1 studies
- Intranasal administration elicits immune responses
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”), a biotech company dedicated to fighting infectious
diseases including COVID-19, today announced favorable preliminary
results from its ongoing Good Laboratory Practice (GLP) toxicology
study to evaluate the safety profile and immunogenicity of its
NT-CoV2-1 vaccine candidate in rabbits. These initial results
continue to demonstrate a safety profile and immune responses that
the Company believes will support regulatory filings required to
progress to a Phase 1 clinical study. The final toxicology report,
including ongoing histopathology evaluation, is expected by
year-end.
“With new variants of COVID-19 continuously arising and
presenting more aggressive transmission, there is a need for novel
protective vaccines,” said Kimberly Murphy, President and CEO. “We
believe our intranasal vaccine candidate will have the potential to
reduce transmission and offers a needle-free COVID-19 vaccine
option. Our intranasal vaccine candidate has previously shown
strong immune responses in preclinical studies against multiple
SARS-CoV-2 variants of interest. We expect to initiate our Phase 1
clinical study by early 2023.”
The objectives of this ongoing toxicology study are to evaluate
the potential toxicity of NT-CoV2-1 following repeated intranasal
administration at the maximal dose anticipated to be used in
humans, and to confirm the immunogenicity of the vaccine.
Oragenics previously published positive preclinical data in
Scientific Reports, a Nature journal,
demonstrating that intranasal administration of NT-CoV2-1 induced
robust antigen-specific IgG and IgA titers in the blood and lungs
of mice and was highly efficacious in a hamster SARS-CoV-2
challenge model, reducing the viral load below the limit of
detection. 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.
About Oragenics, Inc.
Oragenics, Inc. is a development-stage company dedicated to
fighting infectious diseases, including those caused by
coronaviruses and multidrug-resistant organisms. Its lead product
is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19
and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program
leverages coronavirus spike protein research licensed from the
National Institutes of Health (NIH) and the National Research
Council of Canada (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 to commercial antibiotics.
For more information about Oragenics, please visit
www.oragenics.com.
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 the
outcome of preclinical studies, nasal administration, transmission,
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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version on businesswire.com: https://www.businesswire.com/news/home/20220824005080/en/
Oragenics, Inc. Michael Sullivan, Chief Financial Officer
813-286-7900 msullivan@oragenics.com
or
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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