Monkeypox Vaccine Candidate Issued U.S. Patent
New Jersey-based Tonix Pharmaceuticals Holding Corp. announced that the United States Patent and Trademark Office issued a patent on May 31, 2022, entitled "Synthetic Chimeric Poxviruses."
This U.S. patent includes claims covering synthetic horsepox virus, which is the basis for the Company's TNX-8011 pre-clinical vaccine candidate to protect people against monkeypox and smallpox.
TNX-801 is a live virus vaccine based on synthesized horsepox under development for percutaneous administration as a vaccine.
Tonix has previously reported positive data from a monkeypox challenge study in non-human primates.
Additionally, the new patent is for the Company's Recombinant Pox Virus (RPV) platform to protect against other pathogens, including the SARS-CoV-2 coronavirus.
Tonix's TNX-801 and RPV vaccine candidates are administered percutaneously using a two-pronged or "bifurcated" needle.
This patent is expected to provide Tonix with U.S. market exclusivity until 2037, excluding any possible patent term extensions or patent term adjustments.
Seth Lederman, M.D., CEO of Tonix Pharmaceuticals, commented in a press release issued on June 1, 2022, "TNX-801 is a horsepox-based live virus vaccine currently in development to protect against monkeypox and smallpox."
"Horsepox was one of the first few viruses ever generated by synthetic biology and remains among the largest."
Tonix's TNX-801 was synthesized based on the sequence of the 1976 natural isolate Mongolian horsepox clone MNR-763.
Horsepox virus and vaccines based on its use as a vector are live replicating viruses that elicit strong immune responses.
Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been exploited as platforms for vaccine development because they possess;
- large packaging capacity for exogenous DNA inserts,
- precise virus-specific control of exogenous gene insert expression,
- lack of persistence or genomic integration in the host,
- strong immunogenicity as a vaccine,
- ability to rapidly generate vector/insert constructs,
- manufacturable at scale, and,
- ability to provide direct antigen presentation.
Relative to vaccinia, horsepox has substantially decreased virulence in mice.
The primary cutaneous reaction or "take" to vaccinia vaccine was described by Dr. Edward Jenner in 1796 and has been used since then as a biomarker for protective immunity to smallpox, including in the World Health Organization's accelerated smallpox eradication program that successfully eradicated smallpox in the 1960's.
The "take" measures functional T cell immunity validated by eradicating smallpox, a respiratory-transmitted disease caused by variola.
Currently, a new monkeypox vaccine, Jynneos® (MVA-BN, IMVANEX), has been licensed by the U.S. FDA since 2019 to prevent monkeypox and smallpox.
As of June 2, 2022, Jynneos is being offered to monkeypox close-contacts in various countries, including the USA.
Media reporting indicates about 33 countries have reported over 730 potential monkeypox cases in less than one month.
Note: Tonix's press release was manually curated for mobile readership.