Tetherex Pharmaceuticals Signs Exclusive Worldwide License with Mayo Clinic for Development and Commercialization of a Novel Single-Cycle Adenovirus Vaccine Platform
-Phase 1 Clinical Study in COVID-19 Underway in Australia-
OKLAHOMA CITY, July 6, 2021 /PRNewswire/ -- Tetherex Pharmaceuticals, Inc., a privately held, clinical stage biopharmaceutical company developing novel selectin inhibitor products to treat inflammatory diseases, today announced that it has executed an exclusive worldwide license with Mayo Clinic for the development and commercialization of a novel single-cycle adenovirus vaccine platform. The platform will be used to target multiple infectious diseases, beginning with a Phase 1 clinical study investigating a vaccine for COVID-19. Dosing of the initial cohort of the Phase 1 study is underway in Australia.
"Current adenovirus vaccines under investigation for COVID-19 and other infectious diseases are highly restricted in the amount of vaccine antigen they can deliver to cells," said Dr. Russell Rother, President and Chief Operating Officer of Tetherex. "The single-cycle adenovirus platform allows one round of robust vaccine antigen expression to occur without the generation of infectious virus particles which, in preclinical models, translates to a marked improvement in the ensuing immune response."
The single-cycle adenovirus platform was developed to enhance the expression of target antigens, amplifying immune responses to infectious disease targets. Preclinical studies have demonstrated that the single-cycle adenovirus can markedly increase target antigen expression over that of currently utilized replication defective adenovirus vaccines. Intranasal administration of single-cycle vaccine elicits both systemic and mucosal immune responses. A mucosal response allows the immune system to encounter respiratory viruses like SARS-CoV-2 at the site of entry while the viral titers are lower. The platform also provides a robust manufacturing and supply chain paradigm relative to other vaccine platforms, such as mRNA.
The company's Phase 1 open label study, designed to assess safety, reactogenicity and immunogenicity of the single-cycle adenovirus vaccine, is expected to recruit a total of approximately 80 healthy volunteers and includes both a single ascending dose group and a multiple dose group. Subjects will receive the vaccine via either intramuscular or intranasal administration.
"The single-cycle adenovirus vaccine engine amplifies SARS-CoV-2 spike antigen production nearly 100-fold when compared to matched replication-defective adenoviruses," noted Michael Barry, Ph.D., a Mayo Clinic infectious diseases researcher and co-inventor of the adenovirus platform. "Single-cycle is particularly potent as a nasal vaccine, fighting SARS at its site of entry."
"The addition of this novel vaccine platform to the Tetherex portfolio significantly expands our ability to leverage our scientific and clinical development expertise and broadens our overall technology base. This reduces risk to our investors while providing the potential of significant upside," said Dr. Scott Rollins, Chairman and Chief Executive Officer of Tetherex. "The platform will be utilized to target multiple infectious diseases which allows Tetherex to seek partnerships and alliances for the ever-expanding infectious disease marketplace."
Mayo Clinic and Dr. Barry each have a financial interest in the technology referenced in this announcement. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research. No further details regarding the exclusive worldwide license agreement were disclosed.
About Tetherex Pharmaceuticals, Inc.
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SOURCE Tetherex Pharmaceuticals, Inc.