Oragenics Initiates COVID-19 Challenge Study Evaluating Multiple Formulations of its SARS-CoV-2 Vaccine Candidate
- Category: Vaccines
- Published on Wednesday, 15 September 2021 15:33
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Intranasal and Intramuscular Formulations to be Assessed with Novel Adjuvants
TAMPA, FL. USA I September 15, 2021 I Oragenics, Inc. (NYSE American: OGEN) (“Oragenics” or the “Company”) today announced the initiation of a study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study. The study will provide data for several vaccine formulations, using adjuvants specific for both intranasal and intramuscular routes of administration. An assessment of cross-neutralization titers against the Wuhan, Beta and Delta variants of COVID-19 and reduction in the viral load of the Wuhan challenge virus will be used to establish the most promising formulations to advance to human clinical studies. The study is being conducted by the Company’s Canadian collaborator with results expected in November.
“We are delighted to have begun this important study on schedule and soon after receiving favorable results from our mouse immunogenicity study. We believe the results from this hamster challenge study will further affirm our development strategy for Terra CoV-2. We have particular interest for the intranasal delivery route. The findings from this second preclinical study will be a part of our Investigational New Drug filing to the U.S. Food and Drug Administration, expected to be made in the first quarter of 2022, to advance the most promising formulations into human clinical studies,” said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.
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 Terra CoV-2, a vaccine candidate to prevent COVID-19 and variants of the SARS-CoV-2 virus. The Terra CoV-2 program leverages coronavirus spike protein research licensed from the NIH and the NRC with a focus on addressing supply-chain challenges, and offering more patient-friendly administration, such as intranasal. Its lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to commercial antibiotics.