Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, announced today that the
United States Patent and Trademark Office (USPTO) issued U.S.
Patent No. 11,345,896 to the Company on May 31, 2022. This patent,
entitled "Synthetic Chimeric Poxviruses," includes claims covering
synthetic horsepox virus, the basis for the Company’s TNX-8011
vaccine in development to protect against monkeypox and smallpox
and for the Company’s Recombinant Pox Virus (RPV) platform to
protect against other pathogens, including SARS-CoV-2. This patent
is expected to provide Tonix with U.S. market exclusivity until
2037, excluding any possible patent term extensions or patent term
adjustments.
“This patent is an important milestone in
protecting our expanding pipeline of vaccines that address known
and potentially novel pathogens,” said Seth Lederman, M.D., Chief
Executive Officer of Tonix Pharmaceuticals. “TNX-801 is a
horsepox-based live virus vaccine currently in development to
protect against monkeypox and smallpox. TNX-18401 and TNX-18501 are
designed to express the spike proteins from the SARS-CoV-2 omicron
and BA.2 variants, respectively. Horsepox was one of the first few
viruses ever generated by synthetic biology and remains among the
largest. As we prepare to advance horsepox-based live virus
vaccines into clinical development, we are excited to have this new
patent as an important element of our patent estate.”
About TNX-801, TNX-1840 and
TNX-1850TNX-801 is a live virus vaccine based on
synthesized horsepox2,3. Tonix is developing TNX-801 for
percutaneous administration as a vaccine to protect against
monkeypox and smallpox. Tonix has previously reported positive data
from a monkeypox challenge study in non-human primates4. Tonix is
also developing TNX-1840 and TNX-1850 (horsepox-based live virus
vaccines) for the prevention of COVID-19. TNX-1840 and TNX-1850 are
designed to express the spike protein from the omicron and BA.2
variants of SARS-CoV-2, respectively. Tonix has previously reported
positive data from a SARS-CoV-2 challenge study in non-human
primates in which animals were vaccinated with TNX-1800, a
horsepox-based vaccine expressing spike protein from the Wuhan
strain5. Tonix’s TNX-801 was synthesized2 based on the
sequence of the 1976 natural isolate Mongolian horsepox clone
MNR-763. Molecular analysis of DNA sequences suggests that TNX-801
is closer than modern smallpox vaccines to the vaccine discovered
and disseminated by Dr. Edward Jenner in 17986-8. For
example, recent studies9,10 have shown approximately 99.7% colinear
identity between TNX-801 and the circa 1860 U.S. smallpox vaccine
VK05.11 The small plaque size in culture of TNX-801 appears
identical to the U.S. Centers for Disease Control publication of
the natural isolate12. Relative to vaccinia, horsepox has
substantially decreased virulence in mice2. Dr. Edward Jenner
invented vaccination in 1798 and the procedure was called
“vaccination” because ‘cow’ is ‘vacca’ in Latin and the inoculum
material was initially obtained from lesions on the udders of cows
affected by a mild disease known as cowpox. However, Dr. Jenner
suspected that cowpox originated from horses.8 Subsequently,
Dr. Jenner and others immunized against smallpox using material
directly obtained from horses. The use of vaccines from horses was
sometimes called ‘equination’ from the Latin ‘equus’ which means
‘horse’13. Equination and vaccination were practiced side-by-side
in Europe13,14.
About the Recombinant Pox Virus (RPV)
PlatformHorsepox 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; (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) manufacturable at
scale, and (7) ability to provide direct antigen presentation.
Relative to vaccinia, horsepox has substantially decreased
virulence in mice2. Horsepox-based vaccines are designed to be
single dose, vial-sparing vaccines, that can be manufactured using
conventional cell culture systems, with the potential for mass
scale production and packaging in multi-dose vials. Tonix’s TNX-801
and RPV vaccine candidates are administered percutaneously using a
two-pronged, or “bifurcated” needle. The major 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
(WHO) accelerated smallpox eradication program that successfully
eradicated smallpox in the 1960’s. The “take” is a measure of
functional T cell immunity validated by the eradication of
smallpox, a respiratory-transmitted disease caused by variola.
About Monkeypox and
SmallpoxMonkeypox15 and smallpox16 are diseases in humans
called by the monkeypox and smallpox (or variola) viruses,
respectively. Monkeypox and variola are closely related orthopox
viruses. Vaccination against smallpox with live virus vaccines
based on horsepox or vaccinia protects against monkeypox. After
routine smallpox vaccination was stopped in about 1970, monkeypox
has become a growing problem in Africa. Recently approximately 300
cases have been identified outside of Africa.17 Smallpox is
considered eradicated, but there are concerns about malicious
reintroduction.
About Tonix Pharmaceuticals Holding
Corp.1Tonix is a clinical-stage
biopharmaceutical company focused on discovering, licensing,
acquiring and developing therapeutics to treat and prevent human
disease and alleviate suffering. Tonix’s portfolio is composed of
central nervous system (CNS), rare disease, immunology and
infectious disease product candidates. Tonix’s CNS portfolio
includes both small molecules and biologics to treat pain,
neurologic, psychiatric and addiction conditions. Tonix’s lead CNS
candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is
in mid-Phase 3 development for the management of fibromyalgia with
a new Phase 3 study launched in the second quarter of 2022 and
interim data expected in the first quarter of 2023. TNX-102 SL is
also being developed to treat Long COVID, a chronic post-acute
COVID-19 condition. Tonix expects to initiate a Phase 2 study in
Long COVID in the second quarter of 2022. TNX-1300 (cocaine
esterase) is a biologic designed to treat cocaine intoxication that
is expected to start a Phase 2 trial in the second quarter of 2022.
TNX-1300 has been granted Breakthrough Therapy Designation by the
FDA. Finally, TNX-1900 (intranasal potentiated oxytocin), a small
molecule in development for chronic migraine, is expected to enter
the clinic with a Phase 2 study in the second half of 2022. Tonix’s
rare disease portfolio includes TNX-2900 (intranasal
potentiated oxytocin) for the treatment of Prader-Willi syndrome.
TNX-2900 has been granted Orphan-Drug Designation by the FDA.
Tonix’s immunology portfolio includes biologics to address organ
transplant rejection, autoimmunity and cancer, including
TNX-1500 which is a humanized monoclonal antibody targeting
CD40-ligand being developed for the prevention of allograft and
xenograft rejection and for the treatment of autoimmune diseases. A
Phase 1 study of TNX-1500 is expected to be initiated in the second
half of 2022. Tonix’s infectious disease pipeline consists of a
vaccine in development to prevent smallpox and monkeypox called
TNX-801, next-generation vaccines to prevent COVID-19, and a
platform to make fully human monoclonal antibodies to treat
COVID-19. Tonix’s lead vaccine candidates for COVID-19 are TNX-1840
and TNX-1850, which are live virus vaccines based on Tonix’s
recombinant pox vector (RPV) live virus vaccine platform.
1All of Tonix’s product candidates
are investigational new drugs or biologics and none have been
approved for any indication2Noyce RS, et al. (2018) PLoS One.
13(1):e01884533Tulman ER, et al. (2006) J
Virol. 80(18):9244-58.PMID:169405364Noyce, 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)5Tonix
Press Release March 16, 202a
https://ir.tonixpharma.com/news-events/press-releases/detail/1255/tonix-pharmaceuticals-reports-positive-covid-19-vaccine 6Schrick
L et al. N Engl J Med. (2017) 377:1491.7Qin et al. J. Virol.
89:1809 (2015).8Jenner E. “An Inquiry Into the Causes and
Effects of the Variolae Vaccinae: A Disease Discovered in Some of
the Western Counties of England, Particularly Gloucestershire, and
Known by the Name of the Cow Pox.” London: Sampson
Low, 1798.9Brinkmann A et al, Genome Biology (2020)
21:286 https://doi.org/10.1186/s13059-020-02202-010Duggan
A et al. Genome Biology (2020)
21:175 https://doi.org/10.1186/s13059-020-02079-z 11Tonix
press release. Dec 4, 2020
https://ir.tonixpharma.com/news-events/press-releases/detail/1236/vaccine-genome-researchers-report-99-7-colinear-identity12Trindale
GS et al. Viruses (2016) (12). Pii:
E328. PMID:2797339913Esparza E, et al Vaccine.
(2017) 35(52):7222-7230.14Esparza J et al. Vaccine. (2020);
38(30):4773-4779.15www.cdc.gov/poxvirus/monkeypox/about.html16www.cdc.gov/smallpox/research/17Mandavilli,
A. The New York Times. May 26, 2020. “Who is protected against
monkeypox”
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 the failure to obtain FDA clearances or approvals and
noncompliance with FDA regulations; delays and uncertainties caused
by the global COVID-19 pandemic; 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, 2021, as filed with the Securities and
Exchange Commission (the “SEC”) on March 14, 2022, 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 (corporate)Tonix
Pharmaceuticalsinvestor.relations@tonixpharma.com(862) 799-8599
Olipriya Das, Ph.D. (media)Russo
PartnersOlipriya.Das@russopartnersllc.com(646) 942-5588
Peter Vozzo (investors)ICR
Westwickepeter.vozzo@westwicke.com(443) 213-0505
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