Oragenics Initiates COVID-19 Challenge Study Evaluating Multiple Formulations of Its SARS-CoV-2 Vaccine Candidate
UF startup and UF Innovate | Sid Martin Biotech graduate Oragenics, Inc. 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 a particular interest in 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.
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