26 August 2022 - - US-based biotech company Oragenics, Inc. (NYSE American: OGEN) has reported favorable preliminary results from its ongoing Good Laboratory Practice toxicology study to evaluate the safety profile and immunogenicity of its NT-CoV2-1 vaccine candidate in rabbits.

These initial results continue to 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.

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.

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 was highly efficacious in a hamster SARS-CoV-2 challenge model, reducing the viral load below the limit of detection.

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.

Oragenics 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 and the National Research Council of Canada 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.