No toxicity found in NT-CoV2-1, supports regulatory filing for Phase 1 study
Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, today announced results indicating no toxicity signals or adverse events from its Good Laboratory Practices (GLP) toxicology study in rabbits evaluating the safety and immunogenicity of its NT-CoV2-1 intranasal vaccine candidate. Oragenics believes the findings of the final toxicology report, including a full histopathology evaluation, confirm a safety and immunogenicity profile that further support its plan to submit regulatory filings required to progress to a Phase 1 clinical study.
“There is an unmet medical need for an intranasally administered COVID-19 vaccine. We are encouraged by these favorable toxicology study results, which advance the preclinical work required for pursuing regulatory permission to begin human testing. This marks an important milestone in the progress of bringing an intranasal COVID-19 vaccine to the market,” said Kim Murphy, President and Chief Executive Officer of Oragenics. “Signals of adequate immune responses have been demonstrated in prior preclinical studies with NT-CoV2-1 against multiple SARS-CoV-2 variants of interest. We expect to provide an update on our regulatory pathway in the first quarter of 2023.”
The objectives of the toxicology study were 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.
Oragenics previously published positive preclinical data in Scientific Reports, a Nature journal, demonstrating that intranasal administration of NT-CoV2-1 induced robust antigen-specific IgG and IgA titers in the blood and lungs of mice, and reduced viral load below the limit of detection in a hamster SARS-CoV-2 challenge model. 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.
About Oragenics, Inc.
Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases, including those caused by coronaviruses and multidrug-resistant organisms. Its lead product is NT-CoV2-1, an intranasal vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institutes of Health (NIH) and the National Research Council of Canada (NRC) with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics. For more information about Oragenics, please visit www.oragenics.com.
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