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):e01884532Tulman ER, et
al. (2006) J Virol. 80(18):9244-58.PMID:169405363Schrick 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:279733996Noyce, 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
)
*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.
Further information about SR can be found
at https://southernresearch.org.
About Tonix Pharmaceuticals Holding Corp.
Tonix 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.
*TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an
investigational new drug and has not been approved for any
indication.
**Tonmya has been conditionally accepted by the FDA as the
proposed trade name for TNX-102 SL for the treatment of PTSD.
***TNX-1300 (T172R/G173Q double-mutant cocaine esterase 200 mg,
i.v. solution) is an investigational new biologic and has not been
approved for any indication.
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, risks related to
failure to obtain FDA clearances or approvals and noncompliance
with FDA regulations; risks related to the timing and progress of
clinical development of our product candidates; 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 substantial competition. 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, 2018, as filed with the Securities and
Exchange Commission (the “SEC”) on March 18, 2019, and periodic
reports on Form 10-Q filed with the SEC on or after the date
thereof. Tonix does not undertake any obligation to update or
revise any forward-looking statements, whether as a result of new
information, future events or otherwise, except as required by
law.
Contacts
Bradley Saenger (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(212) 688-9421
Travis Kruse (media)Russo
Partnerstravis.kruse@russopartnersllc.com (212) 845-4272
Peter Vozzo (investors)Westwickepeter.vozzo@westwicke.com (443)
213-0505
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