Oragenics’ SARS-CoV-2 Spike Protein Produces Neutralizing Antibodies in Mice with Intramuscular and Intranasal Adjuvants
August 30 2021 - 7:30AM
Business Wire
New data supports Company’s approach to
COVID-19 vaccine development.
Oragenics, Inc. (NYSE American: OGEN) (the Company)
announces that the stabilized pre-fusion spike protein trimer
produced by its Canadian collaborator and licensed by the Company
from the National Institutes of Health (NIH) generates neutralizing
antibodies in mice after immunization against SARS-CoV-2, when
administered with several novel intramuscular (IM) and intranasal
(IN) adjuvants. The expression platform, developed with support
from Oragenics’ Canadian collaborator, will expedite the evaluation
of hybrid SARS-CoV-2 antigen candidates that are scheduled to be
evaluated in a hamster viral challenge study beginning with dosing
at the end of this month. The mouse immunogenicity study enabled
the down-selection of the four adjuvant candidates tested thus far,
with two being advanced to assess inhibition of viral replication
in hamsters, and IND-enabling toxicology studies. A manuscript
suitable for publication, inclusive of the mouse data, will be
prepared upon completion of the hamster study.
“We are delighted that our SARS-CoV-2 spike protein produced
with the high-throughput expression platform from our collaborator
shows promise in the development of a next-generation COVID-19
vaccine, and believe this research affirms our development strategy
with Oragenics’ lead vaccine candidate, Terra CoV-2,” said Fred
Telling, Ph.D., Executive Chair of Oragenics. “We are pleased to
see a robust immunological response with both our novel IM and IN
adjuvants. Additionally, we are optimistic about the pre-clinical
intranasal data given the respiratory route of transmission of the
SARS-CoV-2 virus, and the prospect of developing a novel vaccine
candidate that has the potential to reduce viral transmission. The
data substantiates our choice of adjuvants to use in subsequent
animal and ultimately human studies. We expect to file an IND
application with the FDA in the first quarter of 2022.”
Dr. Telling concluded, “Oragenics continues to believe that our
licensed platform will improve development speed, while the ability
to rapidly engineer new vaccine antigens will permit us to quickly
address new variants as they arise, which will be key in the event
that SARS-CoV-2 becomes a seasonal flu-like disease, as many
experts anticipate will be the case.”
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210830005202/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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