Benzinga | Jan 7, 2021 07:03AM EST

Oragenics Enters Into Material Transfer Agreement With Adjuvance Technologies For COVID-19 Vaccine Adjuvant

Oragenics, Inc. (NYSE:OGEN) ("Oragenics" or the "Company") announced entering into a material transfer agreement with Adjuvance Technologies Inc. for use of the adjuvant TQL1055 in the Company's Terra CoV-2 vaccine against COVID-19. Adjuvants are added to vaccines to enhance their immunogenicity. TQL1055 is a novel, rationally designed semi-synthetic analogue of the saponin adjuvant QS-21 with improved attributes including stability and manufacturing efficiency.

The initial agreement calls for TQL1055 to be used in pre-clinical animal studies supporting the U.S. Food and Drug Administration ("FDA") Investigational New Drug ("IND") application expected to be conducted during the first quarter of 2021, with the opportunity to enter into a licensing agreement to include human clinical studies expected to begin later in 2021.

"The execution of this material transfer agreement is an important step in the ongoing development of our Terra CoV-2 vaccine," said Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics. "Following our Type B Pre-IND meeting with the FDA, we were asked to conduct additional preclinical animal testing for inclusion in our IND filing. Access to TQL1055 will permit us to generate the data necessary to continue development of the vaccine along our currently expected timelines."

The Terra CoV-2 vaccine plus the TQL1055 adjuvant will be studied in hamster viral challenge studies, mouse immunogenicity studies, and the rodent toxicology study required for the IND filing.

Dr. Joslyn added, "Because our vaccine uses an adjuvant, we anticipate a more intense immune response from our prefusion stabilized spike protein with a lower antigen dose. We also believe that our vaccine may have application to other coronaviruses that emerge or strengthen in the future. We recognize that COVID-19 vaccines are now becoming available in the U.S. and worldwide with more vaccines expected to be available in the future, given the scope of the pandemic and the mutation of the virus, we believe there will be demand for the Terra CoV-2 vaccine once development is completed. Of note, the Terra CoV-2 vaccine permits storage and distribution at normal refrigerated temperatures which should aid in its distribution."

Dr. Tyler Martin, Chief Executive Officer of Adjuvance Technologies noted, "We are delighted to be partnering with Oragenics and believe that our adjuvant, TQL1055, will provide the increased immune response necessary for a successful and widely available coronavirus vaccine."