Full Press Release Details
Enters into Licensing Agreement with the National Research Council of Canada, to Pursue the Rapid Development of Next-Generation SARS-CoV-2
| Agreement provides Oragenics with antigen expression cell line technology capable of producing spike proteins within six to eight weeks of gene sequence definition | ||
| Technology includes the ability to engineer vaccine antigens against SARS-CoV-2 including Wuhan, South African (beta) and other emerging variants of concern |
Fla. (July 27, 2021) - Oragenics, Inc. (NYSE American: OGEN) today announced it has entered into a licensing agreement with
the National Research Council of Canada (NRC) that will enable Oragenics to pursue the rapid development of next-generation vaccines
against the SARS-CoV-2 virus and its variants. The NRC technologies, in combination with the U.S. National Institutes of Health (NIH)
elements found in the Company's Terra CoV-2 vaccine, provide Oragenics with a platform that can generate cell lines for high-yield
production of spike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines
within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell
lines. The NRC technologies, developed with support from the NRC's Pandemic Response Challenge Program, will expedite the evaluation
of SARS-CoV-2 antigen candidates in preclinical and clinical studies.
into this licensing agreement as well as a separate material transfer agreement with the NRC are expected to have a profound, positive
impact on our company's strategic direction and we look forward to pursuing the development of next-generation vaccines against
SARS-CoV-2," said Frederick W. Telling, Ph.D., Oragenics' Executive Chairman. "We believe the combination of our previously
licensed NIH technology with the NRC's swift expression platform will accelerate design of new vaccine candidates that benefit
from the hybrid NIH/NRC constructs. This license enables us to jumpstart IND-enabling animal studies with supplies of spike proteins
to address the wild-type Wuhan virus as well as the Beta (B.1.351 or "South African") variant that is currently of global
concern among public health professionals. Preclinical studies started in June through our collaboration with the NRC. We initiated an
immunogenicity study in mice to evaluate several adjuvant candidates. This study will allow for down-selection of the adjuvant candidates,
with the best being advanced into a hamster challenge study to assess inhibition of viral replication and an IND-enabling GLP toxicology
Telling added, "With respect to our potential future competitive positioning against currently available SARS-CoV-2 vaccines, we
believe the licensed technologies will improve development speed, while the ability to rapidly engineer new vaccine antigens will permit
us to quickly address new variants as they arise. In addition, our agreement with Biodextris for an intranasal adjuvant is expected to
complement our intramuscular administration options and should position Oragenics with several antigen-adjuvant options in the event
that SARS-CoV-2 become a seasonal flu-like disease, as many experts anticipate will be the case."
Inc. is a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms.
Its lead product is Terra CoV-2, a vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The Terra CoV-2 program
leverages coronavirus spike protein research licensed from the NIH and the NRC with a focus on addressing supply-chain challenges, and
offering more patient-friendly administration, such as intranasal. Its lantibiotics program features a novel class of antibiotics against
infectious diseases that have developed resistance to commercial antibiotics.
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,"
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factors include, but are not limited to, the following: the Company's ability to advance the development of Terra CoV-2 and lantibiotics
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 the vaccine product candidate, Terra CoV-2 and our lantibiotics, 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 and lantibiotics, 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 variants and 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 and antibiotics; the Company's expectations
as to administration, manufacturing, 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
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Sullivan, Chief Financial Officer