Tonix Pharmaceuticals Announces Exclusive License of Potential Therapeutic or Preventative Humanized anti-SARS-CoV-2 Monoclonal Antibodies from Curia Global, Inc.
December 12 2022 - 7:00AM
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a
clinical-stage biopharmaceutical company, today announced that it
has obtained an exclusive license from Curia Global, Inc., a
leading contract research, development and manufacturing
organization, for the development of three humanized murine
monoclonal antibodies (mAbs) for the treatment or prophylaxis of
SARS-CoV-2 infection. SARS-CoV-2 is the cause of COVID-19.
“We believe that the licensing of these 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 poor clinical outcomes1. Although five monoclonal
antibody products, containing seven distinct monoclonal antibodies,
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, Evusheld®, is still recommended
for use as a prophylaxis by the National Institutes of Health
COVID-19 Treatment Guidelines Panel or FDA2,3. Moreover, concerns
have been raised about the ongoing ability of Evusheld® to
prophylax in the face of new variants4. We believe there is a need
for second generation mAb treatments and prophylactics for
COVID-195. To date, the EUA-approved products have been derived
from the blood of COVID-convalescent patients or a humanized
mouse6,7. The Company believes that humanized murine monoclonal
antibodies discovered by Curia and licensed by Tonix represent a
potential new approach to treating SARS-CoV-2 infection. The
Company believes that murine monoclonal antibodies have the
potential for neutralizing a broader spectrum of SARS-CoV-2
variants and may be harder for SARS-CoV-2 to evade as we face a
‘variant soup’ from both convergent and divergent evolution.”8
Brian Zabel, Ph.D., Senior Director at Curia
said, “We are excited to work with Tonix because of their
commitment to developing therapeutics to COVID-19. Murine
monoclonal antibodies represent a different approach and one that
has the potential to generate high affinity antibodies that
recognize different epitopes on the SARS-CoV-2 spike protein. Mice
have a different repertoire of antibodies and the Curia technology
for generating antibodies optimizes the selection of appropriate B
cells by the timing of immunization, harvesting approach and
screening platform.”
Seth Lederman added, “The potential therapeutic
antibodies licensed leverage our expanding internal development and
manufacturing capabilities for biologics. These murine monoclonal
antibodies and their humanized counterparts build on a base of
knowledge from the fully human monoclonal antibody platform,
TNX-3600, which we are developing with Columbia University.”
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, 20223FDA Updates on Bebtelovimab
www.fda.gov/drugs/drug-safety-and-availability/fda-updates-bebtelovimab-
Accessed Nov 4, 20224Wu, 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?6Hansen
J et al. Science. 2020 Aug 21;369(6506):1010-1014. Doi:
10.1126/science.abd08277 Asdaq, S.M.B. et al. A Patent Review on
the Therapeutic Application of Monoclonal Antibodies in COVID-19.
Int. J. Mol. Sci. 2021, 22, 11953.
https://doi.org/10.3390/ijms2221119538Callaway, E. Oct 28 2022.
Nature (News). COVID ‘variant soup’ is making winter surges hard to
predict: Descendants of Omicron are proliferating worldwide — and
the same mutations are coming up again and again.
www.nature.com/articles/d41586-022-03445-6
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 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.
*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
StatementsCertain 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.
ContactsJessica 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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