Oragenics Initiates a Pivotal IND-Enabling Toxicology Study on its Intranasal COVID-19 Vaccine Candidate, NT-CoV2-1
22 March 2022 - 11:59PM
Business Wire
Data to establish the safety profile and human
dose of vaccine candidate
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) today announced the initiation of a Good Laboratory
Practice (GLP) toxicology study to evaluate the safety profile and
immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits. The
study is designed to provide Investigational New Drug
(IND)-enabling data to help advance this candidate to human
clinical studies. Oragenics has contracted with Frontage
Laboratories (through its wholly owned subsidiary Experimur) to
conduct the study, with top-line interim data expected in
August.
Glenn Washer, Frontage’s North American President and EVP of
Global Safety & Toxicology commented, “We are delighted to
support Oragenics on what could be the next generation of vaccines
to combat COVID-19 infections. With the recent acquisition of
Experimur, Frontage is well positioned to support Oragenics’
development needs through the IND and beyond.”
“We are thrilled to have begun this pivotal study with Frontage,
a premier drug development contract research organization, and are
thankful to the acceleration Frontage has offered our important
IND-enabling study. We believe the results from this rabbit
toxicology study will support our development strategy for our
intranasal COVID-19 vaccine candidate, NT-CoV2-1. The intranasal
delivery route is particularly relevant as it may further reduce
transmission of the virus and provide a needle-free delivery
option. The findings from this preclinical toxicology study will be
a part of our Investigational New Drug filing to the U.S. Food and
Drug Administration,” said Frederick W. Telling, Ph.D., Executive
Chairman of Oragenics.
Oragenics has previously demonstrated protection by NT-CoV2-1 in
a hamster challenge study
(https://www.biorxiv.org/content/10.1101/2022.03.02.482651v1.full.pdf).
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 NT-CoV2-1, an
intranasal vaccine candidate to prevent COVID-19 and variants of
the SARS-CoV-2 virus. The NT-CoV2-1 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. For more
information about Oragenics, please visit www.oragenics.com.
About Frontage Laboratories
Frontage Holdings Corp (1521.HK), together with its wholly owned
subsidiary Frontage Laboratories, Inc., is a global Contract
Research Organization (CRO) which provides integrated,
science-driven, product development services from drug discovery to
late phase clinical process to enable biopharmaceutical companies
to achieve their development goals. Comprehensive services include
drug metabolism and pharmacokinetics, analytical testing and
formulation development, preclinical and clinical trial material
manufacturing, bioanalysis, preclinical safety and toxicology
assessment and early phase clinical studies. Frontage has enabled
many biotechnology companies and leading pharmaceutical companies
of varying sizes to advance a myriad of new molecules through
development and to successfully file global regulatory submissions.
For more details visit: www.frontagelab.com.
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 its vaccine candidate and lantibiotics candidate
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 and lantibiotic product
candidates, 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 vaccines 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 our vaccine candidate 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/20220322005770/en/
Oragenics, Inc. Michael Sullivan, Chief Financial Officer
813-286-7900 msullivan@oragenics.com
LHA Investor Relations Tirth T. Patel 212-201-6614
tpatel@lhai.com
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