Oragenics, Inc. announced that the Company has entered into an exclusive global license agreement with Inspirevax Inc. for its novel intranasal mucosal adjuvant, BDX301, for the development of NT-CoV2-1, Oragenics’ lead intranasal COVID-19 vaccine candidate.
Under the exclusive licensing agreement, Oragenics will pursue the development of NT-CoV2-1 with Inspirevax’s novel BDX301 intranasal mucosal adjuvant. The companies will form a Joint Development Committee (JDC) comprising representatives of both companies to oversee the development efforts collaboratively. Oragenics will make clinical, regulatory and commercial milestone payments, as well as tiered royalty payments. Additionally, the agreement provides a certain period of time for the companies to expand their collaboration to pursue the development of additional intranasal vaccine candidates using Inspirevax’s adjuvants.
“This agreement represents a major milestone for Oragenics and our corporate strategy initiatives to expand our development opportunities. We are excited to collaborate with the experts at Inspirevax to pursue the development of novel intranasal vaccine candidates,” explains Kimberly Murphy, President and Chief Executive Officer of Oragenics. “There is an unmet medical need for an intranasal COVID-19 vaccine. We are currently evaluating formulation options for NT-CoV2-1 and assessing various regulatory pathways to advance this program efficiently and thoughtfully. We are working diligently to advance the program and intend to provide an update in mid-2023.”
“Intranasally delivered vaccines with our BDX301 adjuvant have shown encouraging results in preclinical models for COVID-19 infections. We welcome the opportunity to partner with Oragenics’ in the development of a potential novel intranasal vaccine candidate in the global fight against COVID-19 and infectious disease,” stated Joseph Zimmermann, President and Chief Executive Officer of Inspirevax.
In December 2022, Oragenics reported results indicating no toxicity signals or adverse events from its Good Laboratory Practices toxicology study in rabbits evaluating the safety and immunogenicity of NT-CoV2-1 plus BDX301, including a full histopathology evaluation. Oragenics believes these findings confirm a safety and immunogenicity profile that supports its plan to advance the program further toward clinical study. NT-CoV2-1 vaccine candidate demonstrated a robust antigen-specific IgG and IgA titers in preclinical models and a reduction in viral load is made possible by two complementary technologies, the spike protein licensed from the National Institutes of Health and Inspirevax’s intranasal mucosal adjuvant, BDX301. This enables several potential benefits compared with injectable vaccines, including targeting mucosal immunity, reducing transmission, and offering a needle-free alternative for patients.