Oragenics Announces Publication of Positive Data for its NT-CoV2-1 Intranasal COVID-19 Vaccine Candidate in Scientific Reports

Rhea-AI Summary

Oragenics (AMEX:OGEN), a biotech firm, announced the publication of a study on its intranasal COVID-19 vaccine candidate, NT-CoV2-1, in Scientific Reports. Co-authored with Inspirevax and the National Research Council of Canada, the study demonstrated efficacy in mice and hamsters, highlighting robust immune responses. The company aims to use this data, alongside ongoing toxicology studies, to support its application for human clinical trials. Oragenics focuses on developing treatments for infectious diseases, emphasizing innovative vaccine delivery methods.

Positive

• Publication of intranasal vaccine research in a peer-reviewed journal reinforces credibility.
• NT-CoV2-1 demonstrated efficacy in preclinical trials with strong immune responses in animal models.
• Company plans to advance to human clinical trials, indicating progression in vaccine development.

Negative

• Dependence on ongoing funding for vaccine and lantibiotic development poses a risk.
• Uncertainties remain regarding regulatory approval and future clinical outcomes.

TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotech company dedicated to fighting infectious diseases including coronavirus, announces the publication of an article co-authored by Oragenics and collaborators at Inspirevax and the National Research Council of Canada (“NRC”) Human Health Therapeutics Research Centre in Scientific Reports, a Nature journal. The publication, available [https://rdcu.be/cPyZF] and titled “Intranasal Immunization with a Proteosome-Adjuvanted SARS-CoV2 Spike Protein-Based Vaccine is Immunogenic and Efficacious in Mice & Hamsters,” concluded that Oragenics’ intranasal vaccine candidate, NT-CoV2-1, warrants further development as a novel SARS-CoV-2 vaccine.

“We’re proud to have our innovative intranasal vaccine candidate studies published in a reputable, peer-reviewed scientific journal, and believe this heightened recognition underscores the need for vaccines that address the limitations of currently available options. These published data, and our on-going GLP toxicology study will be part of our preclinical data package seeking permission to enter our first-in human clinical trials,” said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.

The article, which was published as a preprint in bioRxiv in March 2022, describes studies that evaluated a novel spike protein subunit vaccine formulation, NT-CoV2-1, containing a proteosome-based mucosal adjuvant designed for intranasal immunization. The authors concluded that the intranasal formulation induced robust antigen-specific IgG and IgA titers in the blood and lungs of mice and was highly efficacious in a hamster 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.

About Oragenics, Inc.

Oragenics, Inc. is a development-stage company dedicated to fighting infectious diseases including 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 NIH and the 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.

Forward-Looking Statements

This communication contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s beliefs and assumptions and information currently available. The words "believe," "expect," "anticipate," "intend," "estimate," "project" and similar expressions that do not relate solely to historical matters identify forward-looking statements. Investors should be cautious in relying on forward-looking statements because they are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially from those expressed in any such forward-looking statements. These factors include, but are not limited to, the following: the Company’s ability to advance the development of its vaccine candidate and lantibiotics candidate under the timelines and in accord with the milestones it projects; the Company’s ability to obtain funding, non-dilutive or otherwise, for the development of the vaccine and lantibiotic product candidates, whether through its own cash on hand, or another alternative source; the regulatory application process, research and development stages, and future clinical data and analysis relating to vaccines and lantibiotics, including any meetings, decisions by regulatory authorities, such as the FDA and investigational review boards, whether favorable or unfavorable; the potential application of our vaccine candidate to variants and other coronaviruses; the Company’s ability to obtain, maintain and enforce necessary patent and other intellectual property protection; the nature of competition and development relating to COVID-19 immunization and therapeutic treatments and demand for vaccines and antibiotics; the Company’s expectations as to administration, manufacturing, storage and distribution; other potential adverse impacts due to the global COVID-19 pandemic, such as delays in regulatory review, interruptions to manufacturers and supply chains, adverse impacts on healthcare systems and disruption of the global economy; and general economic and market conditions and risks, as well as other uncertainties described in our filings with the U.S. Securities and Exchange Commission. All information set forth in this press release is as of the date hereof. You should consider these factors in evaluating the forward-looking statements included in this press release and not place undue reliance on such statements. We do not assume any obligation to publicly provide revisions or updates to any forward-looking statements, whether as a result of new information, future developments or otherwise, should circumstances change, except as otherwise required by law.

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Oragenics, Inc.

Michael Sullivan, Chief Financial Officer

813-286-7900

msullivan@oragenics.com

Or

LHA Investor Relations

Tirth T. Patel

212-201-6614

tpatel@lhai.com

Source: Oragenics, Inc

FAQ

What recent study was published by Oragenics (OGEN)?

Oragenics published a study on its intranasal COVID-19 vaccine candidate, NT-CoV2-1, in the journal Scientific Reports.

What are the findings of the NT-CoV2-1 vaccine study?

The study found that NT-CoV2-1 induced robust immune responses and was effective in reducing viral load in mice and hamsters.

What are Oragenics' plans after the recent vaccine study publication?

Oragenics aims to use the study data for their application to enter first-in-human clinical trials.

What is the ticker symbol for Oragenics?

Oragenics is traded under the ticker symbol OGEN on the NYSE American.