Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, today announced that Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals,
presented data from the Company’s TNX-801 (live horsepox virus
vaccine) smallpox and monkeypox vaccine development program in an
oral presentation at the World Vaccine and Immunotherapy Congress
2022, being held in San Diego, Calif., November 28 - December 1,
2022. A copy of the Company’s presentation is available under the
Scientific Presentations tab of the Tonix website at
www.tonixpharma.com
“TNX-801 is a live virus vaccine that we believe
is closer to the smallpox vaccines used in the U.S. and Europe
before 1900 than the modern vaccinia smallpox vaccines. TNX-801 has
reduced virulence in animals, and we believe it has the potential
for widespread use to protect against monkeypox,” said Seth
Lederman, M.D., President and Chief Executive Officer. “Recent
global outbreaks of monkeypox have highlighted the need to be
prepared with a vaccine that provides durable immunity and blocks
forward transmission. Tonix’s live virus vaccine technology is
designed to achieve these outcomes.”
The oral presentation titled, “Live Virus
Smallpox and Monkeypox Vaccine,” describes the history of live
virus vaccines and rationale for the development of the Company’s
Recombinant Pox Virus (RPV) platform, including TNX-801 to protect
against monkeypox and smallpox. The presentation describes the
origins of immunization, beginning with the first live virus
vaccine invented by Dr. Edward Jenner in 1798. The inoculation
procedure was called “vaccination” and the inoculum material was
initially obtained from lesions on cows affected by a mild disease
known as cowpox. However, Dr. Jenner suspected that cowpox
originated from horses8,which led to immunization using material
directly obtained from horses. This procedure was sometimes called
“equination”. Equination and vaccination were practiced
side-by-side in Europe13,14. Today, molecular analysis of DNA
sequences from archaic smallpox vaccines suggests that TNX-801 is
closer than modern smallpox vaccinia vaccines to the vaccine
discovered and disseminated by Dr. Edward Jenner6-8.
As presented at the Canadian Society for
Virology in June 2022, non-human primates vaccinated with TNX-801
were fully protected with sterilizing immunity from a challenge
with intra-tracheal monkeypox.
In July 2022, the Company announced a
collaboration with the Kenya Medical Research Institute (KEMRI) to
seek regulatory approval for conducting a Phase 1 clinical study in
Kenya to develop TNX-801 as a vaccine to protect against monkeypox
and smallpox. The study is expected to start in the first half of
2023.
About TNX-801 and TNX-1850
TNX-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-1850 (horsepox-based live virus vaccines) for
the prevention of COVID-19. TNX-1850 is designed to express the
spike protein from the BA.2 variants of SARS-CoV-2. 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 horses8. 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)
Platform
Horsepox 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
Smallpox
Monkeypox15 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.1
Tonix 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 second
quarter of 2023. TNX-102 SL is also being developed to treat Long
COVID, a chronic post-acute COVID-19 condition. Tonix initiated a
Phase 2 study in Long COVID in the third quarter of 2022 and
expects interim data in the second quarter of 2023. TNX-1300
(cocaine esterase) is a biologic designed to treat cocaine
intoxication and has been granted Breakthrough Therapy designation
by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated
in the first quarter of 2023. 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 first
quarter of 2023. TNX-601 ER (tianeptine hemioxalate
extended-release tablets) is a once-daily formulation of tianeptine
being developed as a potential treatment for major depressive
disorder (MDD) with a Phase 2 study expected to be initiated in the
first quarter of 2023. 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 (CD40L or CD154) 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 first half of 2023. Tonix’s
infectious disease pipeline consists of a vaccine in development to
prevent smallpox and monkeypox, next-generation vaccines to prevent
COVID-19, and a platform to make fully human monoclonal antibodies
to treat COVID-19. TNX-801, Tonix’s vaccine in development to
prevent smallpox and monkeypox, also serves as the live virus
vaccine platform or recombinant pox vaccine (RPV) platform for
other infectious diseases. A Phase 1 study of TNX-801 is expected
to be initiated in Kenya in the first half of 2023. Tonix’s lead
vaccine candidate for COVID-19 is TNX-1850, a live virus vaccines
based on Tonix’s recombinant pox live virus vector vaccine
platform.
1All of Tonix’s product candidates
are investigational new drugs or biologics and have not been
approved for any indication.
2Noyce RS, et al. (2018) PLoS One.
13(1):e0188453
3Tulman ER, et al. (2006) J Virol.
80(18):9244-58.PMID:16940536
4Noyce, 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/s13059-020-02202-0
10Duggan 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-identity
12Trindale GS et al. Viruses (2016)
(12). Pii: E328. PMID:27973399
13Esparza 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.html
16www.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) 904-8182
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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