Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, today announced data from
its fully human anti-SARS-CoV-2 monoclonal antibody platform in an
oral presentation delivered by Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals, at the World Antiviral Congress
2022 in San Diego, Calif. The project is part of a broader research
collaboration and option agreement with scientists at Columbia
University designed to fill in important gaps in understanding the
detailed immune responses to COVID-19, and to provide a foundation
upon which to target vaccines and therapeutics to appropriate
individuals by precision medicine. A copy of the presentation is
available under the Scientific Presentations tab of the Tonix
website at www.tonixpharma.com.
The presentation titled, “Platform for
Generating Fully Human anti-SARS-CoV-2 Spike Therapeutic Monoclonal
Antibodies” highlights the need for a broad array of monoclonal
antibodies (mAbs) which can be scaled up quickly and potentially
combined with other mAbs to treat or prevent COVID-19.
“We believe that the development of these fully
human mAbs strengthens our pipeline of next-generation therapeutics
to treat Covid-19,” said Seth Lederman, M.D., Chief Executive
Officer of Tonix Pharmaceuticals. “Immunocompromised individuals,
including organ transplant recipients, are at increased risk of
severe COVID-19 and bad outcomes1. Although five mAb products,
containing 7 distinct mAbs, have received emergency use
authorization (EUA) from the U.S. Food and Drug Administration
(FDA) for either treatment or prophylaxis of COVID-19, only a
single product, Evushield® is still recommended for use as a
prophylaxis by the NIH COVID Guidelines panel or FDA2,3. Moreover,
concerns have been raised about the ongoing ability of Evushield to
serve as a prophylaxis against COVID-19 in the face of new
variants4. For these reasons, we believe there is a need for second
generation mAb treatments and prophylactics for COVID-195.
Generating fully human mAbs starting from recovered patient blood
samples has the potential to reduce the time required to create
novel therapeutics in response to newly identified COVID-19
variants.”
Ilya Trakht, Ph.D., Associate Research
Scientist at Columbia and principal investigator of the
sponsored research agreement said, “We are excited to work with
Tonix because of their commitment to developing therapeutics to
COVID-19. As new variants emerge, anti-spike mAbs that were highly
effective against older variants of SARS-CoV-2, may quickly lose
their place in the treatment landscape. To protect
immunocompromised people, we are committed to assembling a diverse
inventory of monoclonal antibodies to keep pace with circulating
mix of SARS-CoV-2 variants. Our proprietary technology is based on
CD40-ligand promoted B-cell expansion and the MFP-2S human
hybridoma system”
Seth Lederman added, “This potential therapeutic
antibody platform leverages our expanding internal development and
manufacturing capabilities for biologics.”
1Haidar G, Mellors JW. Improving the Outcomes of
Immunocompromised Patients With Coronavirus Disease 2019. Clin
Infect Dis. 2021;73(6):e1397-e1401. Doi:10.1093/cid/ciab397
2https://www.covid19treatmentguidelines.nih.gov/therapies/anti-sars-cov-2-antibody-products/anti-sars-cov-2-monoclonal-antibodies/
- accessed Nov 3, 2022
3“FDA Updates on Bebtelovimab” – “This
information shows that bebtelovimab is not expected to neutralize
Omicron subvariants BQ.1 and BQ.1.1.” –
www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab-
Accessed Nov 4, 2022
4Wu, K.J. October 29, 2022. The Atlantic. “The
End of Evusheld: If you’re immunocompromised, this … isn’t great.
www.theatlantic.com/health/archive/2022/10/covid-variants-antibody-treatments-immunocompromised/671929/
5Madison Muller, M. November 16, 2022 Bloomberg.
“Doctors Are Running Out of Antibody Drugs to Treat Covid as Virus
Mutates.”
www.bloomberg.com/news/articles/2022-11-16/covid-s-mutations-leave-doctors-with-far-fewer-antibody-drugs-to-treat-virus?
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 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 fourth
quarter of 2022. 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.
*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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