Oragenics Signs Process Development and Manufacturing Agreement With Avid Bioservices for Coronavirus Vaccine
August 20 2020 - 8:30AM
Business Wire
Avid Well Positioned to Meet Significant
Scale-Up Requirements for NIH-Licensed SARS-CoV-2 Spike Protein
Vaccine Candidate
Oragenics, Inc. (NYSE American: OGEN) and Avid Bioservices, Inc.
(NASDAQ:CDMO) (NASDAQ:CDMOP), today announced that the companies
have entered into a process development and drug substance
manufacturing agreement. Under terms of the agreement, Avid will
provide Oragenics with analytical method development, process
development and drug substance manufacturing services to support
development of Oragenics’ novel SARS CoV-2 (COVID-19) spike protein
vaccine candidate, Terra CoV-2.
Avid and Oragenics will immediately commence the initial phase
of the project, which includes analytical method feasibility and
qualification activities. Following completion of these initial
activities the companies plan to advance to upstream and downstream
process development and CGMP drug substance manufacturing of Terra
CoV-2 within Avid’s state-of-the-art Myford facility. These
activities are designed to support Oragenics’ goal of advancing its
Terra CoV-2 vaccine candidate into human clinical trials by early
2021.
“Avid specializes in recombinant protein production, a critical
component in the development and potential commercialization of our
lead coronavirus vaccine candidate, Terra CoV-2,” said Alan Joslyn,
Ph.D., president and chief executive officer of Oragenics. “With
Avid’s existing manufacturing infrastructure, which includes three
2000L single-use bioreactors and considerable space for expansion,
they are the right manufacturing partner to scale-up to the
significant levels of bulk vaccine substance that would be required
to combat COVID-19, should our vaccine be approved by regulatory
authorities.”
“We are delighted by Oragenics’ selection of Avid Bioservices to
provide essential CDMO services to support the company’s
development of its COVID-19 vaccine candidate. As the COVID-19
pandemic continues to have a tremendous impact around the world,
there is a critical need for reliable, high-quality development and
manufacturing services for potential vaccines that may offer
protection against the novel coronavirus. At Avid, we believe that
our 27 years of experience in manufacturing complex biologics and
track record of excellence in meeting customers’ CDMO needs
positions us to make an important contribution to the global
coronavirus response,” said Timothy Compton, chief commercial
officer of Avid.
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. Through Noachis Terra, a wholly-owned
subsidiary of Oragenics, 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 also
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 Avid Bioservices, Inc.
Avid Bioservices is a dedicated contract development and
manufacturing organization (CDMO) focused on development and CGMP
manufacturing of biopharmaceutical drug substances derived from
mammalian cell culture. The company provides a comprehensive range
of process development, CGMP clinical and commercial manufacturing
services for the biotechnology and biopharmaceutical industries.
With 27 years of experience producing monoclonal antibodies and
recombinant proteins, Avid's services include CGMP clinical and
commercial drug substance manufacturing, bulk packaging, release
and stability testing and regulatory submissions support. For
early-stage programs the company provides a variety of process
development activities, including upstream and downstream
development and optimization, analytical methods development,
testing and characterization. The scope of our services ranges from
standalone process development projects to full development and
manufacturing programs through commercialization.
www.avidbio.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
Terra CoV-2 under the timelines and in accord with the milestones
it projects; the Company’s ability to obtain funding for the
development of Noachis Terra’s Terra CoV-2 vaccine, whether through
its own cash on hand, a grant from BARDA, 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 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/20200820005319/en/
Oragenics, Inc. Michael Sullivan Chief Financial Officer
813-286-7900 msullivan@oragenics.com John Marco (Investors)
Managing Director CORE IR 516-222-2560 johnm@coreir.com Jules
Abraham (Media) CORE IR 917-885-7378 julesa@coreir.com Avid
Bioservices, Inc. Stephanie Diaz (Investors) Vida Strategic
Partners 415-675-7401 sdiaz@vidasp.com Tim Brons (Media) Vida
Strategic Partners 415-675-7402 tbrons@vidasp.com
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