Benzinga | Mar 9, 2021 09:16AM EST

Oragenics Enters into Material Transfer Agreement With Biodextris For The Use Of Mucosal Adjuvant In Its Intranasal COVID-19 Vaccine; Financial Details Not Disclosed

Oragenics, Inc. (NYSE:OGEN) ("Oragenics" or the "Company") announced it has entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in the Company's Terra CoV-2 vaccine against COVID-19. Adjuvants are added to vaccines to enhance their immunogenicity. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration.

The initial agreement calls for the three intranasal adjuvants to be used in combination with the Oragenics' antigen vaccine candidate as part of the preclinical immunological evaluation of Terra CoV-2, for the prevention of coronavirus disease caused by infection with SARS-CoV-2 virus. The information generated from the studies employing the new intranasal vaccine candidate would potentially support the U.S. Food and Drug Administration ("FDA") Investigational New Drug ("IND") application and an application to Health Canada to initiate clinical trials. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.

The Terra CoV-2 vaccine plus Biodextris' intranasal mucosal adjuvants will be studied in the preclinical animal studies, including hamster viral challenge studies, mouse immunogenicity studies and the rodent toxicology study required for regulatory approval prior to the initiation human testing.

"This material transfer agreement both expands and advances the development of our Terra CoV-2 vaccine with a novel delivery option," said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. "The Biodextris intranasal mucosal adjuvants in combination with the Oragenics antigen open up new possibilities for a vaccine that could potentially be a more effective and convenient option than those currently available. Given the benefits of intranasal administration along with Terra CoV-2's other advantages, including the potential to be stored and distributed at refrigerated temperatures, we believe there is significant opportunity to help address the worldwide COVID-19 pandemic, particularly in the post-near-term immunization phase where booster shots and potential effectiveness against a variety of COVID-19 variant strains may continue to be required."

Joseph Zimmerman, President of Biodextris, added, "We are delighted to partner with Oragenics on exploring the potential of their Terra CoV-2 vaccine. Our proteosome-based compounds can be powerful adjuvants and offer several advantages, including the ability to elicit both mucosal and serum antibodies while offering innate and adaptive immunity."

About Terra CoV-2