Tonix Pharmaceuticals Announces Research Collaboration with Southern Research to Develop a Potential Vaccine to Protect Against New Coronavirus Disease 2019 (COVID-19) Based on Horsepox Virus (TNX-1800)




NEW YORK, Feb. 26, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today a strategic collaboration with Southern Research to support the development of a vaccine, TNX-1800* (live modified horsepox virus vaccine for percutaneous administration) to protect against the new coronavirus disease, COVID-19, based on Tonix’s proprietary horsepox vaccine platform.  Tonix is developing TNX-801 (live horsepox virus vaccine for percutaneous administration) as a potential smallpox preventing vaccine for the U.S. strategic national stockpile and as a monkeypox preventing vaccine.  The Company believes that its proprietary horsepox virus has the potential to serve as a vector for vaccines to protect against other infectious agents.  The new research collaboration will develop and test a potential horsepox vaccine that expresses protein from the virus that causes COVID to protect against the disease.

There are currently no vaccines to protect against COVID-19. The virus that causes COVID-19 is called SARS-CoV-2 and is reportedly highly contagious.  COVID-19 is associated with a significant rate of mortality.

Under the terms of the research collaboration, Southern Research will test one or more vaccine constructs in the Tonix horsepox vector that express one or more proteins or protein fragments from the virus that causes COVID-19.  The first such potential vaccine is TNX-1800.  The collaboration seeks to leverage Tonix’s horsepox vaccine technology that was originally developed to protect against smallpox but has capabilities as a vector for other infectious diseases.  Tonix has previously reported that horsepox has efficacy as a vaccine and good tolerability in mice1 and cynomolgus macaques2.  Horsepox is closely related to vaccinia vaccines, which are a group of orthopoxviruses that have been used as smallpox vaccines.

Dr. Seth Lederman, CEO of Tonix Pharmaceuticals said, “Although vaccinia vectors are available, different orthopoxvirus strains may behave differently as vectors in part because of their different repertoire of genes that modulate immune responses and host range. Potential advantages of horsepox are the strong immunogenicity we observed in macaques and mice with good tolerability. The protein synthesis connected with a replicating live virus vaccine provides direct antigen presentation, which can stimulate cellular immunity in addition to humoral immunity.”  Dr. Lederman was formerly an associate professor at Columbia University and made significant original contributions to immunology.

Scott Goebel, a senior scientist at Southern Research and principal investigator of the project said, “We look forward to this collaboration to advance a potential COVID-19 vaccine.”  Mr. Goebel has previously worked on vaccinia and orthopoxvirus vaccines for other conditions and has studied coronaviruses.

About Orthopoxvirus Vectors

Horsepox and vaccinia are closely related orthopoxviruses that are believed to share a common ancestor.  The name “horsepox” was derived from the animal from which the virus was isolated.  The natural host is presumed to be wild rodents.  The name “vaccinia” is a term that is applied to a group of related vaccine viruses that were industrially produced by infecting cows.  The terms “vaccinia” and “vaccine” were originally coined by Dr. Edward Jenner (derived from the Latin “vacca” for “a cow”) in his description of an illness in cows (cowpox) that was transferred inadvertently by human hands from horses to cows and from cows to human hands. Jenner was the first to use infectious matter (vaccinia or vaccine) from cowpox to elicit protective immunity to smallpox by intentional “vaccination”.  Although horsepox is not considered to be a vaccinia, modern DNA analysis reveals more variation between different vaccinia strains than between horsepox and certain vaccinia strains.  Live replicating orthopoxviruses, like vaccinia or horsepox, can be engineered to express foreign genes and have been explored as platforms for vaccine development because they possess; (1) large packaging capacity for exogenous DNA inserts, (2) precise virus-specific control of exogenous gene insert expression, (3) lack of persistence or genomic integration in the host, (4) strong immunogenicity as a vaccine, (5) ability to rapidly generate vector/insert constructs, (6) readily manufacturable at scale, and (7) ability to provide direct antigen presentation.

About TNX-801* and TNX-1800*

TNX-801 is a live virus vaccine based on synthesized horsepox1,2.  TNX-1800 is a modified horsepox virus that is designed to express a protein from the virus that causes COVID-19, which is known as SARS-CoV-2. Molecular analysis suggests that TNX-801 has relatively “complete” left and right inverted terminal repeats (ITRs) while different vaccinia isolates have a variety of deletions in the left and right ITRs.  Therefore, TNX-801 has additional genes, relative to vaccinia vaccines, that may play roles in host immune interactions and one or more of such proteins may serve as antigens for protective immunity. Molecular analysis also shows that horsepox is closer than modern vaccines in DNA sequence to the vaccine discovered and disseminated by Dr. Edward Jenner2,3,4.  No new gene elements were added to the natural isolate and the small plaque size in culture appears identical to the U.S. Centers for Disease Control publication of the natural isolate5.  Relative to vaccinia, horsepox has substantially decreased virulence in mice1.  TNX-801 vaccinated macaques showed no overt clinical signs after monkeypox challenge6.

1Noyce RS, et al. (2018) PLoS One. 13(1):e0188453
2Tulman ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536
3Schrick L et al. N Engl J Med. (2017) 377:1491.
4Qin et al. J. Virol. 89:1809 (2015).
5Trindale GS et al. Viruses (2016) (12). pii: E328. PMID:27973399
6Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference - January 29, 2020, Arlington, VA. ( )

*TNX-801 and TNX-1800 are in the pre-IND stage and have not been approved for any indication.

About Southern Research

Founded in 1941, Southern Research (SR) is an independent, 501(c)(3) nonprofit, scientific research organization with more than 400 scientists and engineers working across four divisions: Drug Discovery, Drug Development, Engineering, and Energy & Environment. SR supports the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries. SR works on behalf of the National Cancer Institute, National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA, major aerospace firms, utility companies, and other private and government organizations. SR pursues entrepreneurial and collaborative initiatives to develop and maintain a pipeline of intellectual property and innovative technologies that positively impact real-world problems. SR is developing 18 drugs to combat various forms of cancer, ALS, Alzheimer’s, diabetes, kidney disease, Parkinson’s and tuberculosis, among others.  SR has developed 20 other drugs, including seven FDA-approved cancer drugs—a number rivaling any other U.S. research institute. SR is headquartered in Birmingham, Alabama with additional laboratories and offices in Wilsonville, Alabama; Frederick, Maryland; Cartersville, Georgia; and Houston, Texas.

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