Oragenics Enters Into Material Transfer Agreement With Adjuvance Technologies for COVID-19 Vaccine Adjuvant
January 07 2021 - 7:00AM
Business Wire
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) announced entering into a material transfer agreement
with Adjuvance Technologies Inc. for use of the adjuvant TQL1055 in
the Company’s Terra CoV-2 vaccine against COVID-19. Adjuvants are
added to vaccines to enhance their immunogenicity. TQL1055 is a
novel, rationally designed semi-synthetic analogue of the saponin
adjuvant QS-21 with improved attributes including stability and
manufacturing efficiency.
The initial agreement calls for TQL1055 to be used in
pre-clinical animal studies supporting the U.S. Food and Drug
Administration (“FDA”) Investigational New Drug (“IND”) application
expected to be conducted during the first quarter of 2021, with the
opportunity to enter into a licensing agreement to include human
clinical studies expected to begin later in 2021.
“The execution of this material transfer agreement is an
important step in the ongoing development of our Terra CoV-2
vaccine,” said Alan Joslyn, Ph.D., President and Chief Executive
Officer of Oragenics. “Following our Type B Pre-IND meeting with
the FDA, we were asked to conduct additional preclinical animal
testing for inclusion in our IND filing. Access to TQL1055 will
permit us to generate the data necessary to continue development of
the vaccine along our currently expected timelines.”
The Terra CoV-2 vaccine plus the TQL1055 adjuvant will be
studied in hamster viral challenge studies, mouse immunogenicity
studies, and the rodent toxicology study required for the IND
filing.
Dr. Joslyn added, “Because our vaccine uses an adjuvant, we
anticipate a more intense immune response from our prefusion
stabilized spike protein with a lower antigen dose. We also believe
that our vaccine may have application to other coronaviruses that
emerge or strengthen in the future. We recognize that COVID-19
vaccines are now becoming available in the U.S. and worldwide with
more vaccines expected to be available in the future, given the
scope of the pandemic and the mutation of the virus, we believe
there will be demand for the Terra CoV-2 vaccine once development
is completed. Of note, the Terra CoV-2 vaccine permits storage and
distribution at normal refrigerated temperatures which should aid
in its distribution.”
Dr. Tyler Martin, Chief Executive Officer of Adjuvance
Technologies noted, “We are delighted to be partnering with
Oragenics and believe that our adjuvant, TQL1055, will provide the
increased immune response necessary for a successful and widely
available coronavirus vaccine.”
About Terra CoV-2
In March 2020, Oragenics acquired a non-exclusive license from
the National Institutes of Health (NIH) for its stabilized
prefusion Terra CoV-2 spike protein. Oragenics announced that its
spike protein had 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.
About Oragenics, Inc.
Oragenics, Inc. is focused on the creation of the Terra CoV-2
vaccine candidate to combat the novel coronavirus pandemic and the
further development of effective treatments for novel antibiotics
against infectious diseases. The Company is dedicated to the
development and commercialization of a vaccine candidate providing
specific immunity from novel coronavirus. The Terra CoV-2
immunization leverages coronavirus spike protein research conducted
by the National Institutes of Health. In addition, Oragenics 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.
About Adjuvance Technologies
Adjuvance Technologies Inc. is a privately held
biopharmaceutical company focused on improving health and saving
lives through breakthroughs in vaccine adjuvant design. Its lead
adjuvant, TQL1055, is designed to provide strong improvement in
immune response with fewer adverse events and is in preclinical
development for multiple indications in infectious diseases,
oncology, neurobiology, substance abuse and allergies. More
information is available at www.adjuvancetechnologies.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 Terra CoV-2 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 Noachis
Terra’s Terra CoV-2 vaccine, 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, 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 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; the Company’s expectations as
to 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 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/20210107005308/en/
Oragenics, Inc. Michael Sullivan, 813-286-7900 Chief
Financial Officer msullivan@oragenics.com
or
LHA Investor Relations Kim Golodetz 212-838-3777
kgolodetz@lhai.com
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