Provides update on competitive positioning
of Terra CoV-2 vaccine against SARS-CoV-2, expects to file IND in
3Q21
Oragenics, Inc. (NYSE American: OGEN) today issued the
following letter to stockholders from its President and Chief
Executive Officer, Alan Joslyn, Ph.D.:
To My Fellow Stockholders,
With so much encouraging news recently around COVID-19 vaccine
development, this is an excellent time to update you on Oragenics’
progress with our own vaccine, Terra CoV-2. Recent news heightens
our confidence in our scientific approach. As a reminder, we added
this vaccine candidate as a result of our May 2020 acquisition of
Noachis Terra, and immediately began preclinical work. Noachis
Terra is now a wholly-owned subsidiary of Oragenics.
Both Pfizer and Moderna have announced preliminary safety and
efficacy data from their Phase 3 vaccine studies and recent
Emergency Use Authorizations. We hold a nonexclusive intellectual
property license from the National Institutes of Health (NIH) to
the prefusion stabilized spike protein vaccine candidate. The
Company’s license covers stabilizing the spike protein in the
pre-fusion state, which may permit the number of immunogenic
centers to be increased. This could allow for a greater likelihood
of successful antibody binding, resulting in improved immunogenic
responses. We believe that recent Phase 3 data reported relating to
the Moderna vaccine supports the concept of utilizing the
stabilized spike protein.
In terms of our development of Terra CoV-2, as recently
announced we held a successful pre-Investigational New Drug (IND)
meeting with the U.S. Food and Drug Administration (FDA), with
agreements that allow us to save three to six months on pre-IND
development timelines. The broad support for our approach by the
FDA included a number of activities, including:
- Use of the Research Cell Bank in the early manufacturing
process development;
- Use of early pilot batch manufacture under Good Manufacturing
Processes (GMP) for the anticipated Phase 1 clinical trials;
and,
- Submission of draft toxicology reports during IND filing.
We are optimistic that our vaccine will ultimately prove to have
several advantages.
- The NIH-created stabilized pre-fusion spike protein. The
COVID-19 spike protein is a Class 1 fusion (S) protein which exists
in a somewhat unstable but better immunogenic “prefusion” tertiary
conformation, which in the process of receptor binding and fusion
with a cell changes conformation to a more stable but weaker
immunogenic post-fusion conformation. We believe that using the
stabilized pre-fusion spike protein antigen will lead to a greater
immune response as measured by neutralizing antibody titers.
- Access to a novel rationally designed adjuvant. We have
recently signed an agreement with Adjuvance Technologies Inc. for
the use of TQL1055, a novel, rationally designed semi-synthetic
analogue of the saponin adjuvant QS-21 with potential improved
attributes, including stability and manufacturing efficiency. We
also anticipate that our Terra CoV-2 vaccine will provide long
lasting protection from the SARS-CoV-2 virus with only one or two
doses, with a more rapid immune response compared to vaccines
developed without the inclusion of an adjuvant.
- Standard vaccine storage and distribution conditions. As
presently designed, we believe the Terra CoV-2 vaccine permits cost
effective storage and distribution at refrigerated temperatures,
which should facilitate the distribution and thereby avoid
challenges facing the two mRNA vaccines currently approved under
Emergency Use Authorization in the U.S.
The creation of the Research Cell Bank is now complete and
manufacturing has been transferred to our dedicated biologics
contract development and manufacturing organization Avid
Bioservices, Inc. for upstream and downstream processing. Creation
of the Master Cell Bank, required for later stage manufacturing
will begin in the coming weeks. This work supports our expectation
to file the IND mid-year with commencement of patient enrollment in
the Phase 1 clinical study immediately thereafter. The proposed
Phase 1 study protocol is under development. We will provide
details of the final protocol when the IND is approved.
While the world’s attention is on COVID-19, we also believe that
our vaccine may provide some benefit against other coronaviruses
that, unfortunately, may emerge or strengthen in the coming
years.
In November and December of 2020, we completed financing
transactions, raising cumulative gross proceeds of $12.5 million.
These funds, when combined with our current cash and cash
equivalents, should allow us to advance our vaccine through
IND-enabling studies, including immunogenicity, viral challenge
studies and the toxicology study. We also continue to pursue
non-dilutive funding options as recommended by the Biomedical
Advanced Research and Development Authority (BARDA). In
late-September we announced that BARDA declined to provide funds to
support the development of the Terra CoV-2 vaccine, but noted that
evaluation of vaccine development under the Operation Warp Speed
program, as well as other U.S. government-supported funding
initiatives, can be an avenue for promising vaccine candidates,
which we believe Terra CoV-2 to be.
We firmly believe that even with two or more vaccines projected
to be on the market in the coming months, given the size of the
worldwide pandemic there will be plenty of demand for the Terra
CoV-2 vaccine, once development is successfully completed. Managing
the global COVID-19 pandemic and follow up maintenance period will
only be possible if multiple vaccines become available. Each will
likely have its own particular efficacy characteristics, and each
may have differences in manufacturing and distribution. We believe
our Terra CoV-2 vaccine holds exceptional promise to play an
important role in solving this crisis. We thank our stockholders,
employees, partners and research scientists for their continued
support, and look to the future with optimism and hope.
Sincerely,
Alan Joslyn President and Chief Executive Officer January 14,
2021
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 disease. 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 Institute 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.
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/20210114005389/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
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