Tonix Pharmaceuticals Expands Research Collaboration to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The collaboration will continue to work to identify biomarkers for protective immunity against SARS-CoV-2

Immune correlates of protection can support the development of new and specialized vaccines to protect against COVID-19

Potential for the development of antibody-based COVID-19 therapeutics as a result of the collaboration

CHATHAM, NJ, September 23, 2021 (GLOBE NEWSWIRE) – Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, announced today that it has expanded its research partnership with Columbia University. The research collaboration focuses on studying immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic, as well as studying in vitro T-cell and antibody responses to SARS-CoV-2 , the virus, the COVID. causes -19. The research aims to fill important gaps in understanding the detailed immune responses to COVID-19 and provide a basis for tailor-made vaccines and therapeutics for suitable individuals with precision medicine.

The two main researchers on the collaboration are Ilya Trakht, Ph.D., Associate Research Scientist and Sergei Rudchenko, Ph.D., Assistant Professor of Medical Sciences at Columbia University’s Vagelos College of Physicians and Surgeons.

Dr. Trakht is studying T cell and antibody responses in a variety of ways, including at the cellular level by stimulating T cells in vitro with CoV-2 antigens and generating fully human monoclonal antibodies to SARS-CoV-2. This research has the potential to lead to the isolation, characterization and cloning of therapeutically relevant fully human neutralizing monoclonal antibodies to SARS-CoV-2.

Dr. Rudchenko creates DNA aptamer-based anti-idiotypes against certain monoclonal antibodies developed by Dr. Trakht have been identified. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and accelerate the development of precision medicine vaccines against COVID-19.

The story goes on

“Given the progress and results from the early stages of these projects, we are excited to expand our research collaboration with Columbia University on these precision medicine technologies and potentially develop new monoclonal antibody therapeutics,” said Seth Lederman, MD, President and Chief Executive Officer of Tonix. “Data from this collaboration can provide a roadmap and tools to potentially guide the selection of suitable individuals for COVID-19 vaccine studies and determine which vaccine is appropriate for each person based on the state of their immune system or other physiological characteristics.”

About Tonix Pharmaceuticals Holding Corp.

Tonix is ​​a clinical-stage biopharmaceutical company focused on the discovery, licensing, acquisition and development of small molecules and biologics for the treatment, prevention and relief of human diseases. Tonix’s portfolio consists primarily of product candidates for immunology and the central nervous system (CNS). Tonix’s immunology portfolio includes a COVID-19 platform with product candidates for the prevention and treatment of COVID-19, the treatment of long COVID, and the detection of functional T-cell immunity to COVID-19. Tonix’s lead vaccine candidate for COVID-19, TNX-18001, is a live replicating vaccine based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T-cell response. Tonix reported positive efficacy data from animal studies of TNX-1800 in the first quarter of 2021 and expects to begin a Phase 1 human study in the first half of 2022. TNX-35002 (sangivamycin) is a small molecule antiviral drug used to treat acute COVID-19 and is in the new drug development (IND) phase prior to investigation. TNX-102 SL3 (Cyclobenzaprine HCl Sublingual Tablets) is a low molecular weight drug that is being developed to treat Long COVID, a chronic disease, and is also in the pre-IND stage. Finally, Tonix is ​​developing TNX-2100, an in vivo diagnostic tool to measure the presence of functional T cell immunity to COVID-19. Tonix plans to initiate an initial human clinical trial with TNX-21004 in the fourth quarter of 2021 pending IND approval. Tonix’s immunology portfolio also includes biologics for the treatment of immunosuppression, cancer and autoimmune diseases. The company’s CNS portfolio includes both small molecules and biologics for the treatment of pain, neurological, psychiatric and addictive disorders. Tonix’s lead CNS candidate, TNX-102 SL3, is in mid-phase III development for the treatment of fibromyalgia.

1TNX-1800 is a new biological investigational product and has not been approved for any indication. TNX-1800 is based on TNX-801, a live percutaneous horsepox virus vaccine that is being developed to protect against smallpox and monkey pox.
2TNX-3500 is a new investigational drug in the pre-IND development stage and has not been approved for any indication.
3TNX-102 SL is a new investigational drug and has not been approved for any indication.
4TNX-2100 is a new biological investigational product and has not been approved for any indication.

This press release and additional 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 made possible through the use of forward-looking words such as “anticipate”, “believe”, “predict”, “estimate”, “expect” and “intend” among other things. 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 expressed in such forward-looking statements. These factors include, but are not limited to, risks associated with our research collaboration efforts, risks associated with failure to obtain FDA clearances or approvals, and non-compliance with FDA regulations; Delays and uncertainties due to the global COVID-19 pandemic; Risks associated with the timing and progress of clinical development of our product candidates; our need for additional funding; Uncertainties in patent protection and litigation; Uncertainties about government or third party reimbursement; limited research and development efforts and reliance on third parties; and significant competition. As with any drug in development, there are significant risks associated with the development, regulatory approval and commercialization of new products. Tonix assumes no obligation to update or revise any forward-looking statements. Investors should read the Risk Factors in the Annual Report on Form 10-K for the year ended December 31, 2020 filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2021, and periodic reports filed with the SEC on or after the date of this. All Tonix forward-looking statements are expressly limited by all of these risk factors and other cautionary statements. The information contained herein is only effective as of the date thereof.

contacts

Jessica Morris (Company)
Tonix Pharma
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (Media)
Russian partner
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (Investors)
Westwicke / ICR
peter.vozzo@westwicke.com
(443) 213-0505