Full Press Release Details
Tonix Pharmaceuticals Holding Corp. 8-K
Tonix Pharmaceuticals Announces Extension
of Sponsored Research Agreement with Kansas State University to Develop Live-Virus Vaccine Against COVID-19
TNX-2300, a Live Virus Vaccine Based on a Bovine
Parainfluenza Virus Vector, in Development to Protect Against COVID-19
Co-Expression of the CD40-Ligand Will be Tested
to Direct Immune Response
CHATHAM, N.J., April 5, 2022 (GLOBE NEWSWIRE) -
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced
a new preclinical research agreement with Kansas State University (K-State) to extend the research being performed under its original
agreement. Tonix and K-State are working together to develop a vaccine candidate for the prevention of COVID-19 that utilizes a novel
live virus vaccine vector platform, bovine parainfluenza virus, and also to test the effect of co-expression of the CD40-ligand, also
known as CD154 or 5c8 antigen, to stimulate T cell immunity.
"Vaccines based on live replicating viruses
trigger the immune system by direct stimulation of T cells, with the potential to elicit strong, long-lasting and durable immunity,"
said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "There are currently well over 300 potential COVID-19
vaccines in various stages of develpment1, but relatively very few utilize live replicating viral platforms. TNX-2300* is a
live replicating virus vaccine designed to elicit T cell immunity."
Dr. Lederman continued, "Modern live
virus vaccines in development for COVID-19 use a vector system to present SARS-CoV-2 protein antigens. K-State is studying bovine parainfluenza
virus as the vector. A traditional live virus vaccine approach would use a weakened version of SARS-CoV-2, but SARS-CoV-2 contains genes
that weaken the immune response by thwarting innate immunity. In the first completed phase of the research project, K-State showed that
vaccinating hamsters with bovine parainfluenza virus expressing SARS-CoV-2 spike protein elicited antibody responses to the SARS-CoV-2
spike protein. Our goal in utilizing bovine parainfluenza virus as a live virus vaccine vector is to develop a COVID-19 vaccine that is
well tolerated, produces durable immunity, prevents forward transmission and can be rapidly and broadly deployed."
Under the extended research agreement, K-State
will continue to advance preclinical development of a live replicating virus vaccine to protect against COVID-19 based on bovine parainfluenza
virus and also to test the effect of co-expression of the CD40-ligand.
Attenuated bovine parainfluenza virus has previously
been shown to be an effective antigen delivery vector in humans2-7. Notably and most importantly, following extensive testing
in non-human primates, the attenuated BPI3V was shown to be well tolerated, infectious, immunogenic, and stable in infants and children3,6.
The vector is well suited for mucosal immunization using a nasal atomizer, but it can also be delivered parenterally. The technology also
includes a molecular stimulant called CD40-ligand, which triggers strong immunity, including T cell responses. TNX-2300 is designed to
potentially stimulate immunity against the SARS-CoV-2 spike protein. The research is being directed by Dr. Waithaka Mwangi, Kansas State
University, Department of Diagnostic Medicine/Pathobiology, who is the inventor of the new technology. In addition, K-State has granted
Tonix an option for an exclusive license for the clinical and commercial use of K-State's intellectual property associated with
coronavirus vaccines under this relationship.
*TNX-2300 is an investigational new
biologic at the pre-IND stage of development and has not been approved for any indication.
COVID-19 - Landscape of novel coronavirus candidate vaccine development worldwide, March 2022.
2Liang, B., et al., J. Virol.
3Karron, R. A., et al., Vaccine.
4Haller, A. A., et al., J.
Gen Virol. 2003. 84:2153.
5Schmidt, A. C., et al.,
J. Virol. 2001. 75:4594.
6Karron, R. A., et al., J.
Infec. Diseases. 1995. 171:1107.
6Haller, A. A., et al., J.
Virol. 2000. 74:11626.
About Tonix Pharmaceuticals Holding Corp.
Tonix is a clinical-stage biopharmaceutical company
focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate
suffering. Tonix's portfolio is composed of immunology, rare disease, infectious disease, and central nervous system (CNS) product
candidates. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including
TNX-15001 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 rare disease portfolio includes TNX-29002 for the treatment of Prader-Willi syndrome. TNX-2900
has been granted Orphan-Drug Designation by the FDA. Tonix's infectious disease pipeline includes a vaccine in development to prevent
smallpox and monkeypox called TNX-8013, next-generation vaccines to prevent COVID-19, an antiviral to treat COVID-19, and a
potential treatment for Long COVID. Tonix's lead vaccine candidates for COVID-19 are TNX-1840 and TNX-18504, which are
live virus vaccines based on Tonix's recombinant pox vaccine (RPV) platform. TNX-35005 (sangivamycin, i.v.
solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development. TNX-102 SL6,
(cyclobenzaprine HCl sublingual tablets), is a small molecule drug being developed to treat Long COVID, a chronic post-COVID condition.
Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. The Company'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,
is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study expected to start in the first half of 2022.
Finally, TNX-13007 is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first
1TNX-1500 is an investigational
new biologic at the pre-IND stage of development and has not been approved for any indication.
2TNX-2900 is an investigational
new drug at the pre-IND stage of development and has not been approved for any indication.
3TNX-801 is a live horsepox
virus vaccine for percutaneous administration in development to protect against smallpox and monkeyox. TNX-801 is an investigational new
biologic and has not been approved for any indication.
4TNX-1840 and TNX-1850 are
live horsepox virus vaccines for percutaneous administration, in development to protect against COVID-19. TNX-1840 and TNX-1850 are designed
to express the SARS-CoV-2 spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are investigational new
biologics at the pre-IND stage of development and have not been approved for any indication.
5TNX-3500 is an investigational
new drug at the pre-IND stage of development and has not been approved for any indication.
6TNX-102 SL is an investigational
new drug and has not been approved for any indication.
7TNX-1300 is an investigational
new biologic and has 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 development of TNX-2300; 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