FDA Broadly Supports Oragenics’ Pre-IND Development Program for its SARS-CoV-2 Vaccine
October 06 2020 - 6:30AM
Business Wire
Re-Affirms Plan to File IND Application by
the End of 1Q21, Begin Phase 1 Study in Early 2Q21
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the
“Company”) announced receipt of feedback to its Type B Pre-IND
Meeting Request from the U.S. Food and Drug Administration (“FDA”)
that it is in broad agreement with the Company’s planned approach
to clinical development of its SARS-CoV-2 vaccine, Terra CoV-2. As
a result, the Company believes its timelines for both filing an
Investigational New Drug (“IND”) application and the commencement
of the Phase 1 study will proceed on schedule. Oragenics expects to
file the IND by the end of the first quarter of 2021 and commence
patient enrollment in the Phase 1 clinical study early in the
second quarter of 2021.
“We are very pleased with the FDA’s response to our Type B
Pre-IND meeting request as it permits us to maintain an aggressive
development timeline for our Terra CoV-2 vaccine,” said Alan
Joslyn, Ph.D., President and Chief Executive Officer of Oragenics.
“Important points that are supportive of our planned approach
received favorable feedback.”
Dr. Joslyn added, “The FDA’s response is an important step as we
work to provide a vaccine against SARS-CoV-2 that is focused on the
stabilized prefusion spike protein, with a potential profile that
may include lifetime immunity to COVID-19, and storage and
distribution at refrigerated temperatures. We believe the
commercial opportunity for Terra CoV-2 is robust, and that our
vaccine will find its place in the global fight against this deadly
virus.”
The FDA has requested additional preclinical animal data for
inclusion in the IND filing and plans to provide final comments
upon reviewing that data and the Phase 1 trial protocol. Oragenics
believes that generating the additional data will not impede the
overall development timeline.
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 recently 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 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.
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
TerraCoV-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 TerraCoV-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 TerraCoV-2, including any meetings, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201006005481/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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