TAMPA, Fla.–(BUSINESS WIRE)–Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”), a biotechnology company dedicated to fighting infectious diseases including COVID-19, announces that Kim Murphy, Chief Executive Officer, will be participating in the World Vaccine Congress Washington, being held April 3-6, 2023, in Washington, D.C.
Ms. Murphy will be holding meetings to highlight the company’s lead COVID-19 intranasal vaccine candidate, NT-CoV2-1, and to explore partnering opportunities. Oragenics recently reported favorable toxicology results confirming a safety and immunogenicity profile for NT-CoV2-1 that support plans to submit regulatory filings to proceed to a Phase 1 clinical study. Oragenics believes an intranasal COVID-19 vaccine holds several potential benefits compared with injectable vaccines, including targeting mucosal immunity, reducing transmission and offering a needle-free alternative for patients.
“I am excited to take part in the World Vaccine Congress this year and share our progress toward a highly differentiated intranasal COVID-19 vaccine,” said Ms. Murphy. “We expect strong interest among vaccine experts in this unique program and look forward to advancing to Phase 1 clinical trials in humans.”
Earlier this month Oragenics entered into an exclusive global license agreement with Inspirevax Inc. for its novel intranasal mucosal adjuvant, BDX301. The company is currently evaluating formulation options for NT-CoV2-1 and is assessing various regulatory pathways to advance this program efficiently and thoughtfully.
In December 2022 Oragenics reported no toxicity signals or adverse events from its GLP toxicology study in rabbits evaluating the safety and immunogenicity of NT-CoV2-1. The study objectives were to evaluate potential toxicity 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 the World Vaccine Congress
The World Vaccine Congress is the largest, most established meeting dedicated to vaccines. From basic research to commercial manufacture, this one meeting covers the entire vaccine value chain where science, government and manufacturers all come together to create groundbreaking progress.
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.
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 obtain necessary funding, non-dilutive or otherwise, for the development of the vaccine and lantibiotic product candidates; 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 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 Canadian regulatory authorities 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 and license agreements; 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 the outcome of preclinical studies, nasal administration, transmission, manufacturing, storage and distribution; other potential adverse impacts such as delays in regulatory review, manufacturing delays and supply chain issues, adverse impacts on healthcare systems and disruption of the global economy; the ability to sustain compliance with our exchange listing requirements; 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.
Janet Huffman, Chief Financial Officer
LHA Investor Relations
Tirth T. Patel