Tonix Pharmaceuticals Announces that Results from Preclinical Studies of TNX-1700 Will be Presented in a Poster at the AACR Virtual Annual Meeting 2020

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) announced that preclinical results of TNX-1700 will be presented at the AACR Virtual Annual Meeting II from June 22-24, 2020. The poster titled ‘Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer’ will showcase the enhancement of PD-1 blockade efficacy in colorectal cancer. The company focuses on developing drugs in CNS and immunology with ongoing programs like TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19 protection, expecting data in Q4 2020.

Positive

• Presentation of promising preclinical results for TNX-1700 at a significant conference.
• Ongoing development of multiple product candidates, including TNX-102 SL and TNX-1800, which could benefit from strong market demand.

Negative

• Dependence on future FDA approvals poses a risk to the development timeline of investigational products.
• The need for additional financing could strain resources and affect operations.

NEW YORK, June 17, 2020 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of TNX-1700 (rTFF2) will be presented in a poster at the American Association of Cancer Research (AACR) Virtual Annual Meeting II. The meeting is being held June 22-24, 2020.

Details of poster presentation at AACR 2020:

Title:  Stabilized recombinant trefoil factor 2 (TFF2-CTP) enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer

Authors: Woosook Kim, Na Fu, Phaneendra Duddempudi, Zinaida Dubeykovskaya, Steven Almo, Chandan Guha, Seth Lederman, and Timothy Wang

Poster Session: Combination Immunotherapies 4

Date and Time:  Monday, June 22, 2020, 9:00 a.m. - 6:00 p.m. ET

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead vaccine candidate, TNX-1800*, is based on the horsepox viral vector platform to protect against COVID-19, primarily by eliciting a T cell response. Tonix expects data from animal studies of TNX-1800 in the fourth quarter of this year. TNX-801*, live horsepox virus vaccine for percutaneous administration, is in development to protect against smallpox and monkeypox and serves as the vector platform on which TNX-1800 is based.  Tonix’s lead CNS candidate, TNX-102 SL**, is in Phase 3 development for the management of fibromyalgia. The Company expects results from an unblinded interim analysis in September 2020 and topline data in the first quarter of 2021.  TNX-102 SL is also in development for agitation in Alzheimer’s disease and alcohol use disorder (AUD). The agitation in Alzheimer’s disease program is Phase 2 ready with FDA Fast Track designation, and the development program for AUD is in the pre-Investigational New Drug (IND) application stage. Tonix‘s programs for treating addiction conditions also include TNX-1300* (T172R/G173Q double-mutant cocaine esterase 200 mg, i.v. solution), which is in Phase 2 development for the treatment of cocaine intoxication and has FDA Breakthrough Therapy designation. TNX-601 CR (tianeptine oxalate controlled-release tablets) is another CNS program, currently in Phase 1 development as a daytime treatment for depression while TNX-1900, intranasal oxytocin, is in development as a non-addictive treatment for migraine and cranio-facial pain. Tonix’s preclinical pipeline includes TNX-1600 (triple reuptake inhibitor), a new molecular entity being developed as a treatment for PTSD, TNX-1500 (anti-CD154), a monoclonal antibody being developed to prevent and treat organ transplant rejection and autoimmune conditions, and TNX-1700 (rTFF2), a biologic being developed to treat gastric and pancreatic cancers.

*TNX-1800, TNX-801 and TNX-1300 are investigational new biologics and have not been approved for any indication.

**TNX-102 SL (cyclobenzaprine HCl sublingual tablets) is an investigational new drug 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 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, 2019, as filed with the Securities and Exchange Commission (the “SEC”) on March 24, 2020, 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 Pharmaceuticals
investor.relations@tonixpharma.com
(212) 688-9421

Travis Kruse (media)
Russo Partners
travis.kruse@russopartnersllc.com
(212) 845-4272

Peter Vozzo (investors)
Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

FAQ

What are the results of TNX-1700 presented by Tonix Pharmaceuticals?

The results indicate that TNX-1700 enhances anti-tumor activity of PD-1 blockade in mouse models of colorectal cancer.

When is the poster presentation for TNX-1700 happening?

The poster presentation is scheduled for June 22, 2020, during the AACR Virtual Annual Meeting II.

What is the significance of the TNX-1700 results for Tonix Pharmaceuticals?

The positive preclinical results support the potential of TNX-1700 as a promising candidate in cancer therapies, which may attract investor interest.

What other products is Tonix Pharmaceuticals currently developing?

In addition to TNX-1700, Tonix is developing TNX-102 SL for fibromyalgia and TNX-1800 for COVID-19 protection, with key data expected later in 2020.

What risks does Tonix Pharmaceuticals face in product development?

Tonix faces risks related to FDA approvals, potential delays, the need for additional financing, and competition in the market.