Benzinga | Dec 1, 2021 08:04AM EST

Oragenics Reports COVID-19 Challenge Study Results Evaluating Multiple Formulations Of Its SARS-CoV-2 Vaccine Candidate: 'Both formulations [in hamster model] generated robust immune responses and reduced the SARS-CoV-2 viral loads'

Intranasal and Intramuscular Formulations were Assessed with Novel Adjuvants

TAMPA, Fla.--(BUSINESS WIRE)-- Oragenics, Inc. (NYSE:OGEN) ("Oragenics" or the "Company") today announced the results from its study to evaluate the immunogenicity and viral load reduction impact of its SARS-CoV-2 vaccine candidate in a hamster challenge study. The study provided preclinical data for formulations designed for both intranasal and intramuscular administration.

Both formulations generated robust immune responses and reduced the SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge. By contrast, hamsters in the control groups that had received saline or adjuvants alone had no detectable immune response and substantial viral loads. The vaccines delivered by intranasal and intramuscular routes generated immune responses as measured by multiple assays.

"The very positive results from this hamster challenge study fully support our further development of either the intranasal or intramuscular routes of administration, however we plan to focus on the intranasal delivery route for the Terra CoV-2 vaccine due to the relative lack of competition and anticipated advantages of intranasal vaccine delivery, such as reducing viral transmission, needle-free administration, and ease of distribution, as well as the potential for conferred mucosal immunity which is presently being studied. 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 second quarter of 2022, and should facilitate advancement of the program into human clinical studies," said Frederick W. Telling, Ph.D., Executive Chairman of Oragenics.