Oragenics Provides Update on SARS-CoV-2 (COVID-19) Program
July 10 2020 - 7:30AM
Business Wire
Terminates AG013 Oral Mucositis Development
Program
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or
“the Company”) today provided an update on progress with its
SARS-CoV-2 (COVID-19) vaccine candidate and announced the
termination of its clinical development program with AG013 for the
treatment of severe oral mucositis in cancer patients.
While working with Aragen Bioscience, a leading contract
research organization focused on accelerating preclinical biologics
product development, to advance the Company’s recently acquired
COVID-19 vaccine candidate, TerraCoV2, the National Institutes of
Health-created stabilized pre-fusion spike protein gene has been
successfully inserted into Chinese Hamster Cells (“CHO”) and
“mini-pool” production and analytical development are underway. The
transfer to full-scale manufacture is expected to commence later
this summer.
Separately, following a further review of new data and other
factors related to the Company’s international multicenter Phase 2
clinical trial of AG013 in oral mucositis, Oragenics has determined
to cease further development of AG013 in this indication by
discontinuing the trial and withdrawing the applicable
Investigational New Drug application. As a result, on July 9, 2020,
the Company, Precigen, Inc. (“Precigen”) and Precigen’s wholly
owned subsidiary mutually agreed to terminate the Exclusive Channel
Collaboration (“ECC”) agreement for AG013 as a treatment of severe
oral mucositis in cancer patients. The Company expects to continue
to comply with any applicable regulatory requirements with respect
to discontinuing the clinical trial.
“As we await Biomedical Advanced Research and Development
Authority (“BARDA”) and other federal and state non-dilutive grant
decisions, we expect to use our available cash to continue
development of TerraCoV2, with the goal of bringing this COVID-19
vaccine candidate into human clinical trials by early 2021,” said
Alan Joslyn, Ph.D., President and CEO of Oragenics. “Although the
Phase 2 AG013 clinical trial demonstrated activity in certain
patient populations, the overall lack of efficacy along with other
factors, inclusive of strategic product portfolio considerations,
led us to the decision to discontinue further development of AG013
under the ECC.”
About Oragenics, Inc.
Oragenics, Inc. is focused on developing the TerraCoV2
immunization product candidate to combat the novel coronavirus
pandemic and the further development of effective treatments for
novel antibiotics against infectious disease. Through its wholly
owned subsidiary Noachis Terra, the Company is dedicated to the
development and commercialization of a vaccine candidate providing
specific immunity from the novel coronavirus, SARS-CoV-2, which
causes COVID-19. The TerraCoV2 immunization leverages coronavirus
spike protein research conducted by the National Institutes of
Health, which issued a worldwide, nonexclusive intellectual
property license to Noachis Terra. In addition, Oragenics has an
exclusive worldwide channel collaboration with ILH Holdings, Inc.
relating to the development of novel antibiotics.
For more information about Oragenics, please visit
www.oragenics.com.
Safe Harbor Statement
Under the Private Securities Litigation Reform Act of 1995: This
press 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, assumptions and currently available
information. 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, risks
and 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, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20200710005092/en/
Oragenics, Inc. Michael Sullivan Chief Financial Officer
813-286-7900 msullivan@oragenics.com
or
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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