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)

Tonix Pharmaceuticals Holding Corp. 8-K

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)

YORK, February 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.

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.

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.

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.

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.

Orthopoxvirus Vectors

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.

TNX-801* and TNX-1800*

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.

RS, et al. (2018) PLoS One. 13(1):e0188453

ER, et al. (2006) J Virol. 80(18):9244-58.PMID:16940536

L et al. N Engl J Med. (2017) 377:1491.

et al. J. Virol. 89:1809 (2015).

GS et al. Viruses (2016) (12). pii: E328. PMID:27973399

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. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf

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

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.

information about SR can be found at https://southernresearch.org

Tonix Pharmaceuticals Holding Corp.

is a clinical-stage biopharmaceutical company focused on discovering and developing small molecules and biologics to treat pain,

addiction and psychiatric conditions. Tonix's lead product candidate, TNX-102 SL*, is in Phase 3 development as a bedtime

treatment for fibromyalgia and PTSD. The Company is enrolling participants in the Phase 3 RELIEF trial in fibromyalgia and expects

results from an unblinded interim analysis in the third quarter of 2020 and topline data in the first half of 2020. The Phase

3 RECOVERY trial (P302) for TNX-102 SL (trade name Tonmya**) in PTSD has stopped enrollment based on the Independent Data Monitoring

Committee's recommendation to stop the study for futility following an interim analysis of the first 50% of enrolled

participants. Topline data for RECOVERY are expected in the second quarter of 2020. TNX-102 SL for PTSD has U.S. Food and Drug

Administration (FDA) Breakthrough Therapy Designation. TNX-102 SL is also in development for agitation in Alzheimer's

disease and alcohol use disorder (AUD). The agitation in Alzheimer's disease program is Phase 2 ready with FDA Fast Track

designation and the development for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix s programs

for treating addiction conditions also include TNX-1300*** (double-mutant cocaine esterase), which is in Phase 2 development for

the treatment of cocaine intoxication and has FDA Breakthrough Therapy Designation. TNX-601 CR (tianeptine oxalate controlled-release

tablets) is in development as a daytime treatment for depression as well as PTSD and steroid-induced cognitive changes. The first

efficacy study will be performed outside the U.S. TNX-1600 (a triple reuptake inhibitor) is a pre-clinical new molecular entity

being developed as a daytime treatment for PTSD. Tonix's preclinical pipeline includes TNX-1500 (anti-CD154), a monoclonal

antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions and TNX-1700 (rTFF2), a biologic

being developed to treat gastric and pancreatic cancers. TNX-801 (live horsepox virus vaccine for percutaneous administration)

and TNX-1200 (live vaccinia virus vaccine for percutaneous administration) are vaccines to protect against smallpox and monkeypox.

TNX-1800 is in development as a potential vaccine to protect against the new coronavirus, COVID-19. Finally, TNX-701 (undisclosed

small molecule) to prevent radiation effects is being advanced as a medical countermeasure to improve biodefense.

SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug and has not been approved for any indication.

has been conditionally accepted by the FDA as the proposed trade name for TNX-102 SL for the treatment of PTSD.

(T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution) is an investigational new biologic and has not been approved

press release and further information about Tonix can be found at www.tonixpharma.com.

statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995.

These statements may be identified by the use of forward-looking words such as "anticipate," "believe,"