Abstract
TNX-1800 is a synthetically derived live chimeric Horsepox Virus (rcHPXV) vaccine expressing Wuhan SARS-CoV-2 spike (S) protein. The primary objective of this study was to evaluate the immunogenicity and efficacy of TNX-1800 in two nonhuman primate species challenged with USA-WA1/2020 SARS-CoV-2. TNX-1800 vaccination was well tolerated, as indicated by the lack of serious adverse events or significant changes in clinical parameters. A single dose of TNX-1800 generated robust humoral responses in African Green Monkeys and Cynomolgus Macaques, as measured by the total binding anti-SARS-CoV-2 S IgG and neutralizing antibody titers against the USA-WA1/2020 strain. In Cynomolgus Macaques, a single dose of TNX-1800 induced a strong interferon-gamma (IFN-γ) mediated T cell response, promoting both pathogen clearance in the upper and lower airways and generation of systemic neutralizing antibody response against WA strain SARS-CoV-2. Future studies will assess the efficacy of TNX-1800 against newly emerging variants and demonstrate its safety in humans.
Competing Interest Statement
S.J.G., R.N., and S.L. are co-inventors of the TNX-1800 vaccine described in this study. All employees of Tonix Pharmaceuticals, the developer of TNX-1800, own stock or hold stock options. This research was conducted as a collaboration between Tonix Pharmaceuticals and the University of Alberta, Department of Medical Microbiology & Immunology, and Li Ka Shing Institute of Virology with RN salary and project support from funds provided by Tonix Pharmaceuticals. and the funder of this study.
Footnotes
mayanka.awasthi{at}tonixpharma.com; tonymac357{at}gmail.com; dawn.myscofski{at}tonixpharma.com; scott.goebel{at}tonixpharma.com; farooq.nasar{at}tonixpharma.com; sina.bavari{at}tonixpharma.com
jprigge{at}bioqual.com
fkoide{at}southernresearch.org
noyce{at}ualberta.ca
Siobhan.Fogarty{at}tonixpharma.com
helen.stillwell{at}pennmedicine.upenn.edu
bruce.daugherty{at}tonixpharma.com
