Tonix Pharmaceuticals Announces Publication Reporting Synthesis, Construction and Characterization of a Potential Smallpox-Pr...
January 19 2018 - 2:00PM
Tonix Pharmaceuticals Holding Corp. (Nasdaq:TNXP) (Tonix), a
company developing innovative pharmaceutical and biological
products to address major public health challenges, today announced
the publication of research describing the successful synthesis and
characterization of a potential smallpox-preventing vaccine based
on horsepox virus. The research was conducted in conjunction
with scientists from the University of Alberta, a leading Canadian
research university.
The peer-reviewed article, “Construction of an
infectious horsepox virus vaccine from chemically synthesized DNA
fragments,” published in the journal PLOS ONE, follows the
announcement in March of 2017 of the complete synthesis of horsepox
virus using synthetic biology technology. The synthetic horsepox
virus demonstrated the ability to protect against lethal vaccinia
infection in a mouse model which may be indicative of vaccine
protection in humans. Tonix is developing the synthetic version of
horsepox virus from cell culture, designated TNX-801, as a
potential vaccine to prevent smallpox infection in humans.
TNX-801 is at pre-Investigational New Drug (IND) application
stage.
“Evolutionary evidence is building that the vaccines which
largely eradicated smallpox in the U.S. and Europe in the 19th
Century were closely related to horsepox,” stated Seth Lederman,
M.D., President and Chief Executive Officer of Tonix. Dr. Lederman
continued, “We are excited to verify the vaccine protection
activity of TNX-801 in additional animal models and to develop it
as a vaccine to prevent smallpox in humans. Current smallpox
vaccines are used to protect first responders and military service
members who face increased risks of outbreak, but due to
detrimental side effects, they are typically stockpiled in the U.S.
Strategic National Stockpile, but rarely used in practice. We
believe that U.S. servicemembers in the Army’s Global Response
Force are typically vaccinated against smallpox. Because of
the toxicity of modern smallpox vaccine, the U.S. has decided to
stockpile vaccine for use in case of need, rather than immunizing
the whole at-risk population which was the policy prior to
eradication. Our goal is to develop an improved smallpox preventing
vaccine that has a better safety profile and is more suitable for
broader usage.”
“Our hope is that this research will contribute to informed
discussions relating to the potential applications of synthetic
biology to improve public health, stimulate new evaluation of
horsepox-based vaccines, and advance the manufacturing process to
rapidly produce next-generation vaccines and therapeutics,” said
Professor David Evans, Ph.D., FCAHS, Professor and Vice-Dean
(Research), Faculty of Medicine and Dentistry at the University of
Alberta, in Edmonton, Alberta, Canada, and principal investigator
of the TNX-801 research project.
“A new and improved smallpox vaccine would address a
well-recognized risk of the intentional re-introduction of the
smallpox virus - a risk for which governments should prepare,”
commented José Esparza, M.D., Ph.D., former President of the Global
Virus Network, former Senior Advisor on Global Health (Vaccines) to
the Bill and Melinda Gates Foundation and currently adjunct
professor at the Institute of Human Virology at the University of
Maryland School of Medicine, who was not involved in the research.
“To ignore the risk of smallpox intentional re-introduction or to
rely on current vaccines, which have limitations, would not be a
wise choice of biodefense for public health policy makers.”
Horsepox was synthesized by Professor Evans and Research
Associate Ryan Noyce, Ph.D., at the University of Alberta, with Dr.
Lederman as co-investigator of the research and co-inventor of
TNX-801. Under their research and development agreement, Tonix
wholly owns the synthesized horsepox virus stock and related
sequences. Process development work to support TNX-801 pre-IND
activities has begun.
About Horsepox and Smallpox
Horsepox is an equine disease caused by the horsepox virus, and
is believed to have become extinct through some natural process. No
known horsepox outbreaks have been reported since 1976, at which
time the U.S. Department of Agriculture obtained the viral sample
used for the sequence published in 2006 (Tulman, ER. Genome of
Horsepox Virus. Journal of Virology, 2006, 80:9244) on which is
based TNX-801. In 1798, Dr. Edward Jenner, English physician and
scientist, speculated that a vaccine derived from cowpox could
protect humans against smallpox. Jenner had a strong suspicion that
his vaccine, which he isolated from what he called cowpox in cows,
began as a pox disease in horses. As a result of Jenner’s vaccine,
smallpox was eradicated. No cases of naturally occurring smallpox
have been reported since 1977. A recent analysis of a 1902 U.S.
vaccine showed 99.7% similarity to horsepox in the core genome
(Schrick, L. et al. (2017), An Early American Smallpox Vaccine
Based on Horsepox, New England Journal of Medicine 2017; 377:1491).
The modern vaccines were developed after smallpox had been largely
eradicated from the U.S. and Europe and before it was known that
the 19th Century vaccines were closely related to horsepox.
Smallpox-preventing vaccines are maintained in the U.S. Strategic
National Stockpile.
About Tonix Pharmaceuticals Holding Corp.
Tonix is developing innovative pharmaceutical and biological
products to address major public health challenges and diseases
with significant unmet needs. Tonix’s lead product candidate,
Tonmya, or TNX-102 SL, is in Phase 3 development as a bedtime
treatment for PTSD. Due to the unique mechanism of action of the
active ingredient (TNX-102 or cyclobenzaprine hydrochloride) in
Tonmya to improve sleep quality, TNX-102 SL is being developed as a
bedtime treatment for agitation in Alzheimer’s disease. Tonix is
planning to submit an IND for this additional indication in 1Q2018
after completing a successful pre-IND meeting with the FDA in
4Q2017. TNX-601 (tianeptine oxalate) is in the pre-IND application
stage, also for the treatment of PTSD but designed for daytime
dosing. Tonix’s lead biologic candidate, TNX-801, is a potential
smallpox-preventing vaccine based on a live synthetic version of
horsepox virus, currently in the pre-IND application stage.
This press release and further information about Tonix can be
found at www.tonixpharma.com.
Forward Looking Statements
Certain 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,” “forecast,”
“estimate,” “expect,” and “intend,” among others. These
forward-looking statements are based on Tonix's current
expectations and actual results could differ materially. There are
a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements.
These factors include, but are not limited to, substantial
competition; our need for additional financing; uncertainties of
patent protection and litigation; uncertainties of government or
third party payor reimbursement; limited research and development
efforts and dependence upon third parties; and risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations. As with any pharmaceutical under development,
there are significant risks in the development, regulatory approval
and commercialization of new products. Tonix does not undertake an
obligation to update or revise any forward-looking statement.
Investors should read the risk factors set forth in the Annual
Report on Form 10-K for the year ended December 31, 2016, as filed
with the Securities and Exchange Commission (the “SEC”) on April
13, 2017, and periodic reports filed with the SEC on or after the
date thereof. All of Tonix's forward-looking statements are
expressly qualified by all such risk factors and other cautionary
statements. The information set forth herein speaks only as of the
date thereof.
Contacts
Jessica Morris (investors)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com (212)
980-9159
Rich Allan (media)Russo Partners
rich.allan@russopartnersllc.com (646) 942-5588
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