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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. (TNXP) announced preclinical results of its drug, mTNX-1700, which shows enhanced anti-tumor activity in colorectal cancer models when combined with anti-PD-1 therapy. Presented at the Keystone Symposia on March 6, 2023, data demonstrated that mTNX-1700 activates CD8+ T cells and inhibits MDSCs, improving immune response. The company is developing mTNX-1700 as a treatment for colorectal and gastric cancers, and has exclusive U.S. market rights until April 2, 2033, based on licensing from Columbia University. Further studies in humans are planned to assess the drug's potential to modify the tumor microenvironment.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the appointment of R. Newcomb Stillwell to its Board of Directors, effective March 15, 2023. Mr. Stillwell brings nearly 40 years of corporate law experience from Ropes & Gray LLP, where he advised on life science transactions. Tonix's CEO, Seth Lederman, highlighted Stillwell's potential to add strategic value to the company. Tonix focuses on developing therapeutics for various conditions, including fibromyalgia and Long COVID, with several clinical trials underway. Investors await interim data from ongoing studies in 2023.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) recently participated in a virtual event co-hosted by BIO and Solve M.E., discussing Long COVID and its relation to chronic pain syndromes like fibromyalgia and CFS/ME. CEO Seth Lederman highlighted the overlap between Long COVID symptoms and chronic pain conditions. Tonix is advancing its Phase 2 PREVAIL study of TNX-102 SL, targeting Long COVID patients with symptoms similar to fibromyalgia. This randomized study is expected to enroll around 470 participants, with interim analysis anticipated after 50% enrollment.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at a virtual event co-hosted by BIO and Solve M.E. on February 21, 2023, focusing on Long COVID and emerging therapeutic approaches. The session will explore recent research related to Long COVID, a condition affecting many post-COVID-19 patients, and will include participation from various stakeholders, including researchers and policymakers. Registration for the event is publicly available, and the presentation will be accessible on Tonix's website afterward. The company is also advancing clinical studies for its lead candidate TNX-102 SL to manage Long COVID.
Tonix Pharmaceuticals (Nasdaq: TNXP) has secured an exclusive license from Columbia University for developing two monoclonal antibodies (mAbs) aimed at treating and preventing SARS-CoV-2 infections. This decision strengthens Tonix's COVID-19 therapeutic pipeline, particularly for immunocompromised individuals at heightened risk for severe illness. Following the FDA's removal of emergency use authorizations for existing mAb products, TNX-3600 (fully human mAbs) and TNX-4100 (murine mAbs) could provide essential treatment options. These mAbs are poised to neutralize a wider range of SARS-CoV-2 variants and are developed using advanced antibody generation technologies.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced promising preclinical results for its vaccine TNX-801 against monkeypox, demonstrating full protection in non-human primates. This study, published in the journal Viruses, indicates that eight out of eight vaccinated macaques achieved sterilizing immunity against a lethal monkeypox virus challenge. The company plans to initiate a Phase 1 trial for TNX-801 in the latter half of 2023, focusing on protecting against both monkeypox and smallpox. The vaccine is a live virus based on horsepox, designed for single-dose administration and favorable for large-scale production.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced the enrollment of the first participant in its Phase 2 PREVENTION study for TNX-1900, an intranasal formulation of oxytocin aimed at preventing chronic migraines. This double-blind, placebo-controlled study will enroll 300 participants across 25 U.S. sites, with results from an interim analysis expected in Q4 2023. Chronic migraines affect approximately four million people in the U.S., and TNX-1900 is designed to provide a novel treatment option by inhibiting pain signaling mechanisms. The study aims to address an unmet need for effective migraine prevention therapies.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will participate in the BIO CEO & Investor Conference from February 6-9, 2023. A pre-recorded presentation will be available to registered attendees on the conference website. Tonix focuses on developing treatments for diseases, with key candidates including TNX-102 SL in Phase 3 for fibromyalgia and Long COVID, TNX-1300 for cocaine intoxication, and TNX-601 ER for major depressive disorder. The company’s diverse pipeline includes products targeting CNS, rare diseases, immunology, and infectious diseases, with several studies expected to initiate in 2023.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced the acquisition of Healion Bio, Inc., including its next-generation antiviral technology assets. This includes TNX-3900, a series of oral antiviral agents with a novel host-directed mechanism that inhibits cathepsin proteases, essential for viral infection, particularly against SARS-CoV-2. CEO Seth Lederman highlighted the potential of TNX-3900 as a broad-spectrum antiviral, usable as both monotherapy and in combination with other antivirals. The acquisition is expected to enhance Tonix's drug development capabilities at its Frederick, MD facility, aiming to advance TNX-3900 into clinical trials.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has announced a sponsored research agreement with the University of Maryland, Baltimore, to investigate the prevention of heart xenograft rejection using TNX-1500, a monoclonal antibody targeting CD40-ligand. Preclinical studies will use genetically-modified porcine hearts from Revivicor, Inc. A positive outcome could support an IND application and further human clinical trials. TNX-1500, designed to reduce thrombosis risk, may play a crucial role in preventing organ rejection. A Phase 1 study is anticipated to initiate in Q2 2023.
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