Science & Technology
|Program||Process/Analytical Development||In Vitro POC||IND-Enabling Toxicology|
Next-Generation COVID-19 Vaccine
Targeting Mucosal Immunity
When the SARS-CoV-2 virus enters the nasal cavity, the respiratory epithelial layer is the first barrier against viral infection. The intranasal route of vaccination provides two additional layers of protection over intramuscular shots because (i) it produces immunoglobulin A and resident memory B and T cells in the respiratory mucosa that are an effective barrier to infection at those sites, and (ii) cross-reactive resident memory B and T cells can respond earlier than other immune cells should a viral variant start an infection.
In-Licensed Sequence for Making Recombinant SARS-CoV-2 Spike Protein
In March 2020, Oragenics obtained a nonexclusive license from the U.S. National Institutes of Health (NIH) for its DNA sequence to make a stabilized spike protein as the defining agent in our NT-CoV2-1 vaccine candidate. This is known as a recombinant protein, and a variation was used in the Emergency Use-authorized Moderna mRNA vaccine. This NIH technology establishes a spike protein useful in making both mRNA-based and recombinant protein antigen-based vaccine candidates.
In-Licensed CHO Protein-Expression Cell Line Development Technology
In July 2021, we obtained a license from the Canadian National Research Council (NRC) for their use of Chinese Hamster Ovary (CHO)-based protein technology for recombinant proteins. Utilizing this technology, we can rapidly establish highly productive cell lines for making recombinant spike protein antigens. These antigens can target both the original SARS-CoV-2 virus as well as any present or future emerging variants of concern. This NRC technology expedites preclinical evaluation of antigen candidates, allowing quicker entry of vaccine candidates into clinical studies.
We are partnering with Inspirevax to explore their intranasal (IN) adjuvant BDX301. Evaluation of this adjuvant will progress in a stepwise manner through mouse studies, Syrian hamster virus challenge studies, and, as warranted, Investigational New Drug (IND)-enabling toxicity studies. Once a viable vaccine candidate is identified by these studies and deemed worthy of evaluation in human clinical studies, a regulatory application will be submitted.
Oragenics’ unique class of lantibiotics are engineered to deliver unprecedented advantages when fighting antibiotic-resistant infections. Lantibiotics as a class originate from Gram-positive bacteria. These potent antimicrobial agents are effective against bacteria that cause healthcare-acquired infections, or HAIs, by binding with and sequestering their molecular target, Lipid II (shown to be an attractive target for antibiotics). We have discovered a novel mechanism of action for our lantibiotics—a breakthrough that may help reduce antibiotic resistance in bacteria strains that are inherently resistant to most front-line therapies.
Oragenics has made significant strides in resolving some of the most important limitations of lantibiotics by developing innovative methods for large-scale production and purification of pharmaceutical-grade compounds.
Research & Data