OGEN - Oragenics enters into material transfer agreement for COVID-19 vaccine adjuvant

Oragenics ([[OGEN]] +25.0%) has entered into a material transfer agreement with Adjuvance Technologies for use of the adjuvant TQL1055 in Oragenics’ Terra CoV-2 vaccine against COVID-19.TQL1055 is a novel, rationally designed semi-synthetic analogue of the saponin adjuvant QS-21 with improved attributes including stability and manufacturing efficiency. Adjuvants are added to vaccines to enhance their immunogenicity.The initial agreement allows TQL1055's use in pre-clinical animal studies supporting the FDA's Investigational New Drug application expected to be conducted in Q1 2021, with the opportunity to enter into a licensing agreement to include human clinical studies later in 2021.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.In October, the company received feedback to Type B Pre-IND Meeting Request from the FDA that the Agency is in broad agreement with the company’s clinical development program for its SARS-CoV-2 vaccine, Terra CoV-2.

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Oragenics enters into material transfer agreement for COVID-19 vaccine adjuvant