Tonix Pharmaceuticals Announces Acquisition of Preclinical Infectious Disease Portfolio from Healion Bio, Inc.
02 Fevereiro 2023 - 9:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the
Company), a clinical-stage biopharmaceutical company, today
announced an agreement whereby Tonix has acquired all of the assets
of Healion Bio, Inc. (Healion) including its entire portfolio of
next-generation antiviral technology assets. Healion’s drug
portfolio includes a class of broad-spectrum small molecule oral
antiviral drug candidates with a novel host-directed mechanism of
action. Host-directed antivirals modulate human cells and tissues
and are different from direct-acting antivirals which inhibit virus
proteins and processes. Tonix’s TNX-3900, formerly known as HB-121,
are cathepsin protease inhibitors, some of which have strong
activity in vitro against SARS-CoV-2.
“We are excited to develop Healion’s drug
programs that include TNX-3900, which is a class of drugs with
potential broad spectrum anti-viral activity, either as
monotherapies or in combination with other antivirals”, said Seth
Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
“Broad-spectrum antiviral agents have the potential to reduce viral
load and allow the adaptive immune system to alert the other arms
of the immune system to mount a protective response. Examples of
other classes of host-directed antivirals that have been approved
by the U.S. Food and Drug Administration (FDA) include alpha
interferon like Pegasys® (peginterferon alfa-2a) for viral
hepatitis, the CCR5 antagonist Selzentry® (maraviroc) for HIV, and
the anti-IL-6 receptor antagonist monoclonal antibody Actemra®
(tocilizumab) for COVID-19.”
Sina Bavari, Ph.D., Executive Vice President for
Infectious Disease Research at Tonix said, “I am pleased to be
reunited with the infectious disease assets of Healion, since I was
the scientific founder of Healion after I retired from my position
as Chief of R&D at the United States Army Medical Research
Institute of Infectious Disease (USAMRIID). While Healion made some
progress developing these advanced technologies, Tonix’s
state-of-the art facilities and depth of drug development expertise
have the potential to advance the TNX-3900 class of drugs into
clinical trials. On behalf of the talented scientific team that I
direct at our 48,000 square-foot cutting-edge infectious disease
research facility in Frederick, Md., I am pleased to add this
technology to the therapeutic development programs underway.”
About TNX-3900
TNX-3900 is the term for a series of molecules
that inhibit essential cathepsins which are required by viruses
such as coronaviruses and filoviruses to infect cells. Because of
the unique antiviral mechanism of these compounds, the Company
believes they can potentiate the activity of other antivirals with
differing mechanisms. The Company believes this makes cathepsin
inhibitors suitable for combination therapy.
Tonix Pharmaceuticals Holding
Corp.*
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. 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 second 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 second quarter of 2023. Tonix’s
infectious disease pipeline includes a vaccine in development to
prevent smallpox and monkeypox, TNX-801, a next-generation vaccine
to prevent COVID-19, TNX-1850, a platform to make fully human
monoclonal antibodies to treat COVID-19, TNX-3600, and humanized
anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, recently licensed
from Curia. 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 second half of 2023.
*All of Tonix’s product candidates are
investigational new drugs or biologics and have 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 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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