Coronaviruses are a large family of viruses that cause upper-respiratory tract infections. In 2019, the severe acute respiratory syndrome (SARS) coronavirus-2 (CoV-2) virus caused the disease we now know as COVID-19. In addition to CoV-2, multiple other coronaviruses have moved from animal carriers to human carriers in recent decades. For more information on COVID-19, visit the CDC website.
In late July of 2022, the World Health Organization’s estimates indicate the number of worldwide COVID-19 infections have exceeded 566 million and the number of deaths directly attributed to COVID-19 have exceeded 6.4 million.
The overall disease burden from COVID-19 has continued to increase in the U.S. despite 92% of those age 65 or older being fully vaccinated and 72% of those age 5 or older. Current vaccines have reduced the rates of hospitalization and death due to COVID-19 in vaccinated individuals, but the transmission levels even in vaccinated individuals has allowed SARS-CoV-2 variants to continue to circulate.. The market opportunity for COVID-19 vaccines will likely evolve as more of the population receives their primary vaccine doses in 2022-2023.
The booster dose market will be driven by the need for updated vaccines to provide protection against future virus variants, as well as vaccines for unvaccinated infants and children. Oragenics is positioning its NT-CoV-2 candidate to compete in this later phase of the COVID-19 vaccine market.
Novel Approach & Opportunity
Oragenics’ lead product in fighting infectious diseases is NT-CoV-2, a vaccine candidate specifically engineered to prevent COVID-19 and future variants of the SARS-CoV-2 virus.
Targeted Mucosal Immunity – Conventional injectable vaccines are poor inducers of mucosal immunity, whereas intranasal immunization can induce strong mucosal immunity by enhancing the immune response at the entry sites of mucosal pathogens.
Needle-Free Administration – As an obvious benefit, intranasal administration means needle-free delivery, resulting in meaningful differentiation for children and needle-phobic populations, improved compliance and the potential for self-administration.
Storage & Transport – The currently available mRNA-based vaccines have been delivered globally via stringent storage and transport requirements that strain distribution logistics under the best of circumstances. A key benefit of our NT-CoV2-1 vaccine candidate is a significantly reduced handling burden, allowing transport at a more manageable refrigeration temperature (5°C) that improves access globally including remote and under-vaccinated geographies.
Durability – Broad initial success with mRNA vaccines has significantly diminished COVID-19’s impact and death, but the trade-off has been fleeting efficacy. By benefitting from the immunological properties of the hybrid NIH/NRC construct, NT-CoV2-1 is potentially much more durable and long-lasting than currently available mRNA-based therapies.
The Oragenics team is pursuing rapid development of next-generation vaccines for CoV-2 and its variants. The NT-CoV-2 platform we are evaluating should allow for the development of new spike proteins in only six to eight weeks—as opposed to six to nine months to create traditional cell lines—prompting a quicker response to future COVID-19 variants, as well as potentially improving access through the development of intranasal delivery and technology.
Intranasal administration is also being tested for our NT-CoV-2 vaccine candidate to reduce the need for needles and improve access to vaccines. This approach may also enhance mucosal immunity of the respiratory tract, offering results comparable to those of the commonly used intramuscular injection route of administration. A mucosal immune response evoked in the inner lining of organs like the nose, mouth, lungs, and stomach could be more effective at reducing the transmission of the CoV-2 virus, in addition to providing long-lasting immunity comparable to current intramuscular vaccines.
Our NT-CoV-2 vaccine candidate induced strong immune responses using intramuscular and intranasal routes of administration in preclinical models. Positive results in mouse immune response studies led to the evaluation of CoV-2 antigen formulations in a hamster challenge study. In December of 2021, we announced that both the intramuscular and intranasal formulations generated robust immune responses and reduced the SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge. Read more below:
Inspirevax (formerly Biodextris)
Inspirevax is a Contract Manufacturing Organization (CMO) that offers analytical, developmental, and bioproduction services as well as extensive biologics experience for vaccine effort collaborations. In March 2021, Oragenics entered into licensing and material transfer agreements with Inspirevax for the use of two intranasal adjuvants in our COVID-19 vaccine program. Our collaboration with Inspirevax allows for the evaluation of these intranasal adjuvants in preclinical studies and the progression of suitable candidates into human clinical studies.
National Research Council of Canada (NRC)
The NRC is Canada’s largest federal research and development organization, partnering with Canadian industries to take research from the lab to the marketplace. The NRC’s market-driven focus delivers fast innovation, enhanced quality of life, and unique solutions to the world’s most pressing problems. In July 2021, Oragenics’ collaboration with the NRC allows rapid development of new CoV-2 vaccine antigens using their proprietary Chinese Hamster Ovary (CHO) protein expression cell line technology.
National Institutes of Health (NIH)
The NIH functions as a part of the U.S. Department of Health and Human Services and is the nation’s medical research agency—making important discoveries that improve public health and save lives. In March 2020, Oragenics obtained a nonexclusive license from the NIH for its DNA sequence to create our recombinant CoV-2 spike protein. Our collaboration allows for the utilization of technology licensed from the NIH that stabilizes the Terra CoV-2 spike antigen in the pre-fusion state.
Learn more here: www.nih.gov/about-nih/who-we-are