Oragenics Announces Positive COVID-19 Challenge Study Results Evaluating Multiple Formulations of its SARS-CoV-2 Vaccine Candidate
December 01 2021 - 8:00AM
Business Wire
Intranasal and Intramuscular Formulations were
Assessed with Novel Adjuvants
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) today announced the results from its study to
evaluate the immunogenicity and viral load reduction impact of its
SARS-CoV-2 vaccine candidate in a hamster challenge study. The
study provided preclinical data for formulations designed for both
intranasal and intramuscular administration.
Both formulations generated robust immune responses and reduced
the SARS-CoV-2 viral loads to undetectable levels in the nasal
passages and lungs five days following a viral challenge. By
contrast, hamsters in the control groups that had received saline
or adjuvants alone had no detectable immune response and
substantial viral loads. The vaccines delivered by intranasal and
intramuscular routes generated immune responses as measured by
multiple assays.
“The very positive results from this hamster challenge study
fully support our further development of either the intranasal or
intramuscular routes of administration, however we plan to focus on
the intranasal delivery route for the Terra CoV-2 vaccine due to
the relative lack of competition and anticipated advantages of
intranasal vaccine delivery, such as reducing viral transmission,
needle-free administration, and ease of distribution, as well as
the potential for conferred mucosal immunity which is presently
being studied. 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, expected to be made in the second quarter
of 2022, 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 Terra CoV-2, a
vaccine candidate to prevent COVID-19 and variants of the
SARS-CoV-2 virus. The Terra CoV-2 program leverages coronavirus
spike protein research licensed from the NIH 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 to commercial antibiotics.
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 Terra CoV-2 and lantibiotics 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 product candidate, Terra CoV-2 and our lantibiotics,
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 Terra CoV-2 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 Terra CoV-2 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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version on businesswire.com: https://www.businesswire.com/news/home/20211201005420/en/
Oragenics, Inc. Michael Sullivan, Chief Financial Officer
813-286-7900 msullivan@oragenics.com
Or
LHA Investor Relations Kim Golodetz 212-838-3777
kgolodetz@lhai.com
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