- Oragenics Inc OGEN announced preliminary results from its ongoing Good Laboratory Practice (GLP) toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits.
- These initial results demonstrate a safety profile and immune responses that the company believes will support regulatory filings required to progress to a Phase 1 clinical study.
- The final toxicology report, including ongoing histopathology evaluation, is expected by year-end.
- "We believe our intranasal vaccine candidate will potentially reduce transmission and offer a needle-free COVID-19 vaccine option," said Kimberly Murphy, President & CEO.
- The objectives of this ongoing toxicology study are to evaluate the potential toxicity of NT-CoV2-1 following repeated intranasal administration at the maximal dose anticipated to be used in humans and to confirm the immunogenicity of the vaccine.
- In both mice and hamsters, the antibodies had strong neutralizing activity, preventing the cellular binding of the viral spike protein based on the ancestral reference strain and variants of concern.
- The company plans to initiate Phase 1 clinical study by early 2023.
- Price Action: OGEN shares are up 25.3% at $0.17 on the last check Thursday.
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