Preclinical Study Shows SARS-CoV-2 Spike Protein Licensed by Oragenics from the NIH Produces Neutralizing Antibodies
July 22 2020 - 7:30AM
Business Wire
Recently published paper supports the
Company’s approach to COVID-19 vaccine development
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) announces that the National Institutes of Health (the
“NIH”) created stabilized pre-fusion spike protein (CoV-2 S-2P)
licensed by the Company has generated neutralizing antibodies in
mice during immunization against SARS-CoV-2, the virus that causes
COVID-19.
The NIH’s preclinical study shows that this spike protein,
adjuvanted with the TLR-4-agonist Sigma Adjuvant System (a TLR-4
agonists that induces T cell activation), generates neutralizing
antibody titers in both a pseudovirus neutralization assay and a
plaque reduction neutralization titer (PRNT) assay. In addition,
this immunization produced a balanced Th1/Th2 response. The results
are reported in Corbett et al. BioRxiv. 2020
(https://www.biorxiv.org/content/10.1101/2020.06.11.145920v1).
“We are delighted that our licensed SARS-CoV-2 spike protein has
been shown to hold promise in the creation of a COVID-19 vaccine,
and believe this research affirms our development strategy with the
Company’s lead vaccine candidate, Terra CoV2,” said Alan Joslyn,
Ph.D., President and Chief Executive Officer of Oragenics. Dr.
Joslyn continued, “We are particularly pleased to see a balanced
Th1/Th2 response, which is one of the most critical parameters used
to assess both safety and efficacy of this vaccine candidate.
TerraCoV2 is currently undergoing development and we anticipate
conducting Phase 1 human clinical studies in early 2021.”
In March 2020 Noachis Terra Inc., a wholly owned subsidiary of
Oragenics, acquired a non-exclusive license from the NIH for this
stabilized prefusion CoV-2 spike protein. The Company recently
announced that its spike protein has been successfully inserted
into Chinese Hamster Ovary (“CHO”) cells and “mini-pool” production
and analytical development are underway. CHO cells are used to
produce a number of FDA approved recombinant proteins. The transfer
to full scale manufacture is expected to commence pending a grant
from the Biomedical Advanced Research and Development Authority
(BARDA).
About Oragenics, Inc.
Oragenics, Inc. is focused on the creation of the TerraCoV2
vaccine candidate to combat the novel coronavirus pandemic and the
further development of effective treatments for novel antibiotics
against infectious disease. Through Noachis Terra, a wholly-owned
subsidiary of Oragenics, the Company is dedicated to the
development and commercialization of a vaccine candidate providing
specific immunity from novel coronavirus. The TerraCoV2
immunization leverages coronavirus spike protein research conducted
by the National Institute of Health. In addition, Oragenics also
has an exclusive worldwide channel collaboration with ILH Holdings,
Inc. (n/k/a Eleszto Genetika, Inc.), relating to the development of
novel lantibiotics.
For more information about Oragenics, please visit
www.oragenics.com.
Safe Harbor Statement
Under the Private Securities Litigation Reform Act of 1995: This
release includes forward-looking statements that reflect
management’s current views with respect to future events and
performance. 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
TerraCoV2 under the timelines and in accord with the milestones it
projects; the Company’s ability to obtain funding for the
development of Noachis Terra’s TerraCoV2 vaccine, whether through
its own cash on hand, a grant from BARDA, or another alternative
source; the regulatory application process, research and
development stages, and future clinical data and analysis relating
to TerraCoV2, including any decisions by regulatory authorities,
such as the FDA and investigational review boards, whether
favorable or unfavorable; 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; 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 risks,
as well as other uncertainties described in our filings with the
U.S. Securities and Exchange Commission. Oragenics assumes no
responsibility to update any forward-looking statements contained
in this press release or with respect to the matters described
herein.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200722005308/en/
Oragenics: Michael Sullivan Chief Financial Officer
813-286-7900 msullivan@oragenics.com
Investors: John Marco Managing Director CORE IR
516-222-2560 johnm@coreir.com
Media: Jules Abraham CORE IR 917-885-7378
julesa@coreir.com
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Oragenics (AMEX:OGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024