Tonix Prescribed drugs Broadcasts Publication of Paper in Antiviral Analysis Highlighting the Firm’s Improvement of Monoclonal Antibody Therapeutics for Monkeypox and Smallpox

CHATHAM, N.J., Jan. 24, 2023 (GLOBE NEWSWIRE) — Tonix Prescribed drugs, Inc. (Nasdaq: TNXP) (Tonix or the Firm), a clinical-stage biopharmaceutical firm, right now introduced the publication of a paper entitled, “Improvement of a speedy image-based high-content imaging screening assay to guage therapeutic antibodies towards the monkeypox virus,” within the journal Antiviral Analysis. The publication describes the event and optimization of two high-content image-based assays that had been employed to display for potential therapeutic antibodies towards the monkeypox virus utilizing surrogate poxviruses similar to vaccinia virus. The article highlights Tonix’s TNX-3400 platform, which incorporates antibodies to doubtlessly forestall or deal with monkeypox and smallpox. The article may be accessed on-line at https://pubmed.ncbi.nlm.nih.gov/36592670/.

“These information symbolize the primary wave of analysis and improvement carried out at our Infectious Illness R&D Middle (RDC) in Frederick, Md,” mentioned Seth Lederman, M.D., Chief Government Officer of Tonix Prescribed drugs. “The RDC drastically enhances our capability to advance improvement of our pipeline of vaccines and therapeutics for infectious illnesses. The TNX-3400 platform has promise for preventative and therapeutic monoclonal antibodies to deal with monkeypox and smallpox.”

“The article describes how we optimized and standardized two high-content high-throughput image-based assays. The primary assay was a neutralizing assay which detected viral proteins of vaccinia virus and used the assay to display a big library of antibodies made towards pox viruses. The second assay particularly detected phenotype modifications in cells, referred to as syncytia, after an infection and safety by therapeutics.” mentioned Sina Bavari, Ph.D., Government Vice President of Tonix Prescribed drugs and website director of the RDC. A important part in assessing antibodies throughout pandemics requires the event of speedy however detailed strategies to detect and quantitate the neutralization exercise. “The neutralizing assay recognized a number of antibodies with the capability to guard towards vaccinia virus an infection. We imagine this expertise will enable us to determine mixture therapies for monkeypox and smallpox viruses which was troublesome to realize earlier than. Moreover, our information counsel that making use of this expertise has the potential to extend the throughput of screening novel antivirals to shorten the invention time for antivirals.”

About TNX-3400

TNX-3400 is the time period for collection of monoclonal antibodies which bind to key elements of pox viruses similar to monkeypox and smallpox and defend cells and tissues from an infection with these pandemic inflicting viruses. These antibodies are being developed as broad-spectrum antipox virus and to doubtlessly forestall or deal with monkeypox and smallpox an infection.

Tonix Prescribed drugs Holding Corp.^*

Tonix is a clinical-stage biopharmaceutical firm targeted on discovering, licensing, buying and creating therapeutics to deal with and stop human illness and alleviate struggling. Tonix’s portfolio consists of central nervous system (CNS), uncommon illness, immunology and infectious illness product candidates. Tonix’s CNS portfolio contains each small molecules and biologics to deal with ache, neurologic, psychiatric and dependancy situations. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual pill), is in mid-Part 3 improvement for the administration of fibromyalgia with a brand new Part 3 research launched within the second quarter of 2022 and interim information anticipated within the second quarter of 2023. TNX-102 SL can be being developed to deal with Lengthy COVID, a continual post-acute COVID-19 situation. Tonix initiated a Part 2 research in Lengthy COVID within the third quarter of 2022 and expects interim information within the third quarter of 2023. TNX-1300 (cocaine esterase) is a biologic designed to deal with cocaine intoxication and has been granted Breakthrough Remedy designation by the FDA. A Part 2 research of TNX-1300 is predicted to be initiated within the first quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in improvement for continual migraine, is predicted to enter the clinic with a Part 2 research within the first quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a possible remedy for main depressive dysfunction (MDD) with a Part 2 research anticipated to be initiated within the first quarter of 2023. Tonix’s uncommon illness portfolio contains TNX-2900 (intranasal potentiated oxytocin) for the remedy of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio contains biologics to deal with organ transplant rejection, autoimmunity and most cancers, together with TNX-1500, which is a humanized monoclonal antibody focusing on CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the remedy of autoimmune illnesses. A Part 1 research of TNX-1500 is predicted to be initiated within the first half of 2023. Tonix’s infectious illness pipeline features a vaccine in improvement to stop smallpox and monkeypox, TNX-801, a next-generation vaccine to stop COVID-19, TNX-1850, a platform to make totally human monoclonal antibodies to deal with COVID-19, TNX-3600, and humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800, lately licensed from Curia. TNX-801, Tonix’s vaccine in improvement to stop smallpox and monkeypox, additionally serves because the reside virus vaccine platform or recombinant pox vaccine (RPV) platform for different infectious illnesses. A Part 1 research of TNX-801 is predicted to be initiated in Kenya within the second half of 2023.

^*All of Tonix’s product candidates are investigational new medication or biologics and haven’t been accepted for any indication.

This press launch and additional details about Tonix may be discovered at www.tonixpharma.com.

Ahead Trying Statements

Sure statements on this press launch are forward-looking inside the that means of the Personal Securities Litigation Reform Act of 1995. These statements could also be recognized by means of forward-looking phrases similar to “anticipate,” “imagine,” “forecast,” “estimate,” “count on,” and “intend,” amongst others. These forward-looking statements are based mostly on Tonix’s present expectations and precise outcomes may differ materially. There are a variety of things that would trigger precise occasions to vary materially from these indicated by such forward-looking statements. These components embody, however usually are not restricted to, dangers associated to the failure to acquire FDA clearances or approvals and noncompliance with FDA rules; delays and uncertainties brought on by the worldwide COVID-19 pandemic; dangers associated to the timing and progress of medical improvement of our product candidates; our want for extra financing; uncertainties of patent safety and litigation; uncertainties of presidency or third social gathering payor reimbursement; restricted analysis and improvement efforts and dependence upon third events; and substantial competitors. As with all pharmaceutical underneath improvement, there are vital dangers within the improvement, regulatory approval and commercialization of latest merchandise. Tonix doesn’t undertake an obligation to replace or revise any forward-looking assertion. Buyers ought to learn the chance components set forth within the Annual Report on Type 10-Ok for the yr ended December 31, 2021, as filed with the Securities and Alternate Fee (the “SEC”) on March 14, 2022, and periodic studies filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly certified by all such threat components and different cautionary statements. The data set forth herein speaks solely as of the date thereof.

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