Vaccine Program

Disease Profile

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.

Market Opportunity

The Pfizer/BioNTech COVID-19 vaccine is projected to reach estimated revenues of $33.5 billion in 20211, whereas the Moderna vaccine is expected see revenues of around $20 billion in 20222. 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 Terra CoV-2 vaccine to compete in this later phase of the COVID-19 vaccine market.

Novel Approach & Opportunity

Oragenics’ lead product in fighting infectious diseases is Terra CoV-2, a vaccine candidate specifically engineered to prevent COVID-19 and future variants of the CoV-2 virus.

Our Terra CoV-2 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and a Chinese Hamster Ovary (CHO) cell line expression system from the National Research Council of Canada (NRC). This enables a production platform that will support faster development of antigens, or immune system response stimulants, to address new CoV-2 variants as they emerge.

The Oragenics team is pursuing rapid development of next-generation vaccines for CoV-2 and its variants. The Terra-COV-2 platform we are evaluating would 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 Delivery

Intranasal administration is also being tested for our Terra CoV-2 vaccine 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.

Proof of Concept Research

Our Terra-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 hamster challenge studies, with results expected in November 2021. Read more below:

See reference: https://www.oragenics.com/news-media/press-releases/detail/131/oragenics-sars-cov-2-spike-protein-produces-neutralizing

2021 NIH Strategic Plan for COVID-19 Research

https://covid19.nih.gov/sites/default/files/2021-05/NIH-Wide-COVID-19-StratPlan_2021_508_1.pdf

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

Vaccine Pipeline Chart

We are currently developing our vaccine product candidates and have other product

candidates positioned for out-licensing or partnering.

Image: https://www.oragenics.com/technology-pipeline 

References

  1. https://www.forbes.com/sites/aayushipratap/2021/07/28/pfizer-expects-335-billion-in-vaccine-revenue-in-2021/?sh=3c6d1eca217d – possible reference
  2. https://www.cnbc.com/2021/11/04/covid-vaccine-moderna-mrna-earnings-q3-2021.html