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Tonix Pharmaceuticals Holding Corp. (symbol: TNXP) is a pioneering biopharmaceutical company dedicated to developing, licensing, and commercializing innovative therapeutics to treat and prevent human diseases. With a focus on central nervous system (CNS) disorders, Tonix is at the forefront of addressing major public health challenges.
One of Tonix's key projects is Tonmya, aimed at treating PTSD, which is currently in advanced stages of development. Additionally, the company is working on TNX-601 (tianeptine oxalate), a daytime treatment for PTSD, and TNX-801, a synthetic version of the horsepox virus, intended as a potential smallpox vaccine, both at the pre-IND (Investigational New Drug) application stage.
The company’s immunology development portfolio includes TNX-1500, a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154), being developed to prevent allograft rejection and treat autoimmune diseases. This portfolio demonstrates Tonix's commitment to addressing both organ transplant rejection and autoimmunity, as well as cancer.
Tonix’s mission to alleviate suffering extends beyond CNS disorders and immunology, as it is also exploring therapeutic solutions for rare and infectious diseases. Their dedication to research and innovation has established partnerships with reputable institutions, such as Massachusetts General Hospital, ensuring that their projects are backed by cutting-edge science and expertise.
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Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that the U.S. Patent and Trademark Office granted U.S. Patent No. 11,167,010 on November 9, 2021. This patent, which covers the TFF2-CTP polypeptide, is expected to provide exclusivity until April 2, 2033. Tonix is developing TNX-1700, a modified form of TFF2, to treat gastric and pancreatic cancers. Data from preclinical studies indicate that TFF2-CTP enhances the effectiveness of anti-PD-1 therapies in colorectal cancer models. TNX-1700 is currently an investigational new biologic and not yet FDA-approved.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that Dr. Seth Lederman, President and CEO, will present at the Q4 Investor Summit on November 17, 2021, at 4:50 p.m. ET. Investors can arrange virtual meetings with management through the conference coordinator. A webcast of the presentation will be available on the Tonix website, with a replay accessible for 90 days post-event.
Tonix focuses on developing therapeutics for various diseases, including candidates for COVID-19 and fibromyalgia. Their lead vaccine candidate, TNX-1800, is expected to start human trials in late 2022.
Tonix Pharmaceuticals announced results from its Phase 1 study of TNX-601 CR, a novel treatment for major depressive disorder (MDD). The study showed that TNX-601 CR demonstrated appropriate pharmacokinetics for once-daily dosing, enhancing treatment adherence compared to immediate release tianeptine. A Phase 2 trial is expected to begin in the first half of 2022, involving approximately 260 participants. The trial aims to evaluate TNX-601 CR's efficacy and safety over six weeks. This formulation is notable as no tianeptine product has been approved by the FDA in the U.S.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced positive results from its Phase 3 RELIEF study of TNX-102 SL for fibromyalgia management. The study met its primary endpoint, significantly reducing daily pain compared to placebo (p=0.01). The responder rate for TNX-102 SL was 47% versus 35% for placebo (p=0.006). Secondary endpoints also showed improvements in sleep and fatigue. Early discontinuation rates were similar for both groups. The company previously halted enrollment in its second Phase 3 study, RALLY, due to disappointing interim results. Topline RALLY results are expected by year-end.
Tonix Pharmaceuticals (Nasdaq: TNXP) reported its Q3 2021 financial results, revealing cash and cash equivalents of approximately $183 million, an increase from $77.1 million at year-end 2020. Significant R&D advancements include the operationalization of its Research and Development Center in Frederick, MD, and the build-out of its Advanced Development Center in New Bedford, MA, aimed at accelerating COVID-19 and infectious disease programs. Planned trials for TNX-2100 and TNX-1300 are expected to commence this quarter, contributing to the company’s expanding pipeline.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at BIO-Europe 2021, taking place virtually from October 25-28, 2021. The presentation will be accessible on demand for registered participants. Tonix focuses on developing treatments for human diseases, particularly in immunology and central nervous system disorders. Their product candidates include TNX-1800, a COVID-19 vaccine, and TNX-3500, an antiviral for acute COVID-19. Tonix aims to start human trials for TNX-2100, an in vivo diagnostic for T cell immunity, in Q4 2021.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the opening of its new 48,000 square foot research and development center in Frederick, Maryland, on October 18, 2021. The center aims to enhance its infectious disease pipeline, particularly for COVID-19 and other pathogens. U.S. Senator Ben Cardin and Congressman David Trone will attend the ribbon-cutting event. Tonix plans to develop vaccines and antiviral therapeutics, utilizing its recombinant pox virus platform technology to respond quickly to emerging pandemic threats. The facility will operate as a biosafety level-3 lab to conduct research on live pathogens.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that Dr. Seth Lederman will participate in a panel discussion at the A.G.P. Fall Virtual Biotech & Specialty Pharma Conference on October 13, 2021, at 12:00 p.m. ET. The panel, titled "Long COVID & COVID variants - How to tackle the still ongoing pandemic", will be moderated by analyst Jim Molloy. Tonix's portfolio includes candidate therapies for COVID-19 and Long COVID, such as the vaccine candidate TNX-1800 and the antiviral drug TNX-3500, both in various stages of development.
Tonix Pharmaceuticals (Nasdaq: TNXP) has acquired a new research and development center in Frederick, Md., which spans approximately 48,000 square feet. This facility will enhance the company's capabilities in developing vaccines and antiviral drugs against COVID-19 and other infectious diseases. Key projects include TNX-1800, a COVID-19 vaccine, TNX-801 for smallpox and monkeypox, and TNX-3500, an antiviral for COVID-19. The center is currently BSL-2 certified, with plans to upgrade to BSL-3 for handling live pathogens.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the acceptance of an oral presentation at the ACR Convergence 2021, scheduled for November 6, 2021. The presentation will focus on TNX-102 SL, highlighting positive results from a Phase 3 trial for fibromyalgia treatment. The company's pipeline also includes candidates for COVID-19, such as TNX-1800, slated for Phase 1 studies in early 2022, and TNX-3500, which is in pre-IND development. Tonix aims to address various health challenges, particularly in immunology and CNS disorders.
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