Oragenics Announces Positive COVID-19 Challenge Study Results
Evaluating Multiple Formulations of its SARS-CoV-2 Vaccine Candidate
Intranasal and Intramuscular Formulations were Assessed with Novel Adjuvants
TAMPA, Fla.--(BUSINESS WIRE)--
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.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
Print Page
Email to a Friend
