Oragenics Initiates COVID-19 Challenge Study Evaluating Multiple Formulations of its SARS-CoV-2 Vaccine Candidate
September 15 2021 - 07:30AM
Business Wire
Intranasal and Intramuscular Formulations to be
Assessed with Novel Adjuvants
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) today announced the initiation of a study to
evaluate the immunogenicity and viral load reduction impact of its
SARS-CoV-2 vaccine candidate in a hamster challenge study. The
study will provide data for several vaccine formulations, using
adjuvants specific for both intranasal and intramuscular routes of
administration. An assessment of cross-neutralization titers
against the Wuhan, Beta and Delta variants of COVID-19 and
reduction in the viral load of the Wuhan challenge virus will be
used to establish the most promising formulations to advance to
human clinical studies. The study is being conducted by the
Company’s Canadian collaborator with results expected in
November.
“We are delighted to have begun this important study on schedule
and soon after receiving favorable results from our mouse
immunogenicity study. We believe the results from this hamster
challenge study will further affirm our development strategy for
Terra CoV-2. We have particular interest for the intranasal
delivery route. 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 first
quarter of 2022, to advance the most promising formulations 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 addressing supply-chain challenges, and offering more
patient-friendly administration, such as intranasal. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210915005418/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
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Feb 2024 to Mar 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Mar 2023 to Mar 2024