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Oragenics Inc. (NYSE American: OGEN) is a publicly-traded biopharmaceutical company specializing in innovative, proprietary technologies aimed at improving human health. Based in Sarasota, Florida, Oragenics is renowned for its cutting-edge research and development in the fields of neurology and infectious diseases. The company’s core business revolves around the development of novel pharmaceutical treatments, including nasal delivery medications, which promise significant advancements in therapeutic efficacy and patient outcomes.
Oragenics’ flagship product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid. Designed to cross the blood-brain barrier effectively, ONP-002 targets mild Traumatic Brain Injury (mTBI), commonly known as concussion. The drug reduces swelling, oxidative stress, and inflammation while restoring proper blood flow through gene amplification. This revolutionary approach positions ONP-002 as a potential game-changer in treating brain injuries.
In addition to ONP-002, Oragenics boasts a diverse product pipeline, including therapies targeting Niemann-Pick Disease Type C (NPC) and other infectious diseases. The company is also recognized for its ProBiora3 technology, which is the foundation of products like evoraplus™—a unique probiotic mint that promotes oral health by supporting gums, freshening breath, and whitening teeth.
Recent achievements highlight Oragenics' relentless pursuit of excellence. The company is preparing to initiate a Phase II clinical trial for ONP-002, with advancements in drug formulation aimed at optimizing intranasal delivery. Collaborating with Avance Clinical Pty Ltd, Oragenics is focused on conducting this trial in emergency departments at level one trauma centers, ensuring robust and well-structured studies.
The leadership team at Oragenics, led by President Michael Redmond and Chief Medical Officer Dr. James Kelly, emphasizes the importance of partnerships and advanced research. Their dedication is reflected in Oragenics' preclinical studies, which have shown significant improvements in molecular and behavioral outcomes following brain injury. The company's innovative approach to intranasal delivery as nanoparticles has further enhanced brain exposure and metabolism.
Oragenics' commitment to addressing unmet medical needs, such as concussions—which affect millions globally each year—has positioned the company as a pivotal player in the biopharmaceutical industry. Through continuous innovation and strategic collaborations, Oragenics aims to provide effective treatments for neurological disorders and improve patient outcomes worldwide.
For more information, visit www.oragenics.com.
Oragenics, Inc. (NYSE American: OGEN) announced preliminary positive results from a GLP toxicology study for its NT-CoV2-1 intranasal COVID-19 vaccine candidate. The data indicates a favorable safety profile and immune response, supporting regulatory filings for a Phase 1 clinical study expected to start by early 2023. Notably, the vaccine candidate has shown strong preclinical immune responses against various SARS-CoV-2 variants, highlighting its potential as a needle-free option to reduce COVID-19 transmission.
Oragenics, Inc. (NYSE American: OGEN) has appointed Kimberly M. Murphy as President and CEO effective June 23, 2022. Murphy, a seasoned vaccine industry leader with over 25 years of experience, has previously held significant roles at companies like Merck and GSK. Her appointment is expected to enhance Oragenics' strategic vision and accelerate growth, particularly in their ongoing vaccine development efforts against infectious diseases, including COVID-19. As a board member since 2020, her insights have already contributed to the company’s strategies.
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.
Oragenics, Inc. (AMEX: OGEN) shared a letter from Executive Chairman Frederick W. Telling, Ph.D., outlining the company’s vaccine development strategy, particularly its intranasal COVID-19 vaccine candidate, NT-CoV2-1. The vaccine aims to address both pandemic and endemic phases of COVID-19. Oragenics has made progress in preclinical studies and plans to initiate a Phase 1 clinical study in North America. The company is positioning NT-CoV2-1 as a single-dose booster to meet evolving market demands, highlighting its advantages in mucosal immunity, needle-free administration, and logistical ease.
Oragenics, Inc. (NYSE American: OGEN) announced its participation in the World Vaccine Congress Washington from April 18-22, showcasing its lead product, NT-CoV2-1, an intranasal COVID-19 vaccine candidate. The vaccine aims for patient-friendly administration and robust immune response. NT-CoV2-1 has shown promising results in animal studies, with a Phase 1 trial expected to begin this year. Kimberly Murphy, a board member and former GSK executive, will represent the company. Oragenics focuses on combating infectious diseases, leveraging research from NIH and NRC.
Oragenics has extended its licensing agreement with the National Research Council of Canada to develop an intranasal vaccine targeting future variants of coronaviruses. This collaboration leverages NRC's rapid cell expression technologies, reducing production time for vaccine candidates from months to weeks. The company has also shown promising results with its intranasal NT-CoV2-1 vaccine in preclinical studies, paving the way for further clinical trials.
Oragenics, Inc. (AMEX: OGEN) announced that its 2021 financial statements contained an unqualified audit opinion with a going concern paragraph. This follows compliance with NYSE American regulations regarding audit opinions. The statements reflect no changes or amendments. Oragenics develops infectious disease treatments, including the NT-CoV2-1 intranasal COVID-19 vaccine and a lantibiotics program targeting antibiotic-resistant bacteria. Investors are cautioned about reliance on forward-looking statements due to inherent risks.
Oragenics, Inc. (AMEX: OGEN) has initiated a GLP toxicology study for its NT-CoV2-1 vaccine candidate, targeting safety and immunogenicity in rabbits. This study aims to gather IND-enabling data for human trials. Conducted by Frontage Laboratories, results are expected by August. The vaccine's intranasal delivery may reduce transmission of COVID-19. Previously, NT-CoV2-1 showed protective results in hamsters. The company focuses on combating infectious diseases, leveraging NIH and NRC research for its vaccine development.
Oragenics, Inc. (NYSE American: OGEN) has partnered with KBI Biopharma to manufacture materials for its intranasal vaccine candidate NT-CoV2-1, which targets SARS-CoV-2. The collaboration includes a 200L demonstration and a 500L cGMP run, positioning Oragenics for a future Phase 2 clinical trial. This vaccine aims to enhance protection at the viral entry points in the respiratory tract, potentially reducing transmission compared to traditional intramuscular vaccines. Previous preclinical trials showed significant immune responses and viral load reductions.
Oragenics, Inc. (NYSE American: OGEN) has released a preprint manuscript detailing its intranasal vaccine, NT-CoV2-1, co-developed with Inspirevax and Canada's NRC. The study found that this vaccine formulation is immunogenic and effective in lowering viral loads in hamsters while generating strong antibody responses in both mice and hamsters. The results support continued development, aiming for FDA submission to advance towards human trials. The intranasal delivery method could enhance protection against COVID-19 compared to traditional vaccines.
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