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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 (Nasdaq: TNXP) announced the publication of a research paper detailing the development of rapid imaging assays for therapeutic antibodies against the monkeypox virus. This research was conducted at their Infectious Disease R&D Center in Frederick, Maryland. The study demonstrated the efficacy of the TNX-3400 platform in identifying antibodies that can neutralize the vaccinia virus, which is akin to monkeypox. The company aims to leverage this technology for combination therapies targeting monkeypox and smallpox. The TNX-3400 platform serves as a foundation for potential broad-spectrum antiviral treatments.
Tonix Pharmaceuticals has appointed Dr. Zeil Rosenberg as Executive Vice President, Medical, to lead clinical development for its vaccine and antiviral programs. Dr. Rosenberg will oversee key candidates like TNX-801 for smallpox and monkeypox, TNX-1850 for COVID-19, and monoclonal antibodies TNX-3600 and TNX-3800 targeting severe COVID-19 in immunocompromised patients. His extensive experience in infectious disease and successful vaccine trials from his previous positions at PPD and BD is expected to strengthen Tonix's clinical development efforts during a critical time for its product pipeline.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced that CEO Seth Lederman will present at Biotech Showcase 2023 from January 9-11, 2023, at Hilton San Francisco Union Square. The presentation is scheduled for January 10 at 3:00 p.m. PT. A live webcast will be available on the company’s website. Tonix focuses on developing therapeutics for various diseases, with lead candidate TNX-102 SL in mid-Phase 3 for fibromyalgia. Other programs target Long COVID, cocaine intoxication, chronic migraine, major depressive disorder, and infectious diseases.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) has randomized 50% of participants in the Phase 3 RESILIENT study of TNX-102 SL for fibromyalgia. An interim analysis by an Independent Data Monitoring Committee (IDMC) is anticipated in Q2 2023, with topline results expected in Q4 2023. Positive outcomes in RESILIENT, combined with past positive results from the RELIEF study, could support an NDA submission. Fibromyalgia affects 6-12 million adults in the U.S., highlighting the need for new non-opioid treatments, as current options have not satisfied patient needs since 2009.
Tonix Pharmaceuticals (Nasdaq: TNXP) has secured an exclusive license from Curia Global, Inc. for the development of three humanized murine monoclonal antibodies aimed at treating or preventing SARS-CoV-2 infections. This move comes as existing monoclonal antibody therapies struggle with new COVID-19 variants. CEO Seth Lederman emphasized the need for next-generation treatments, especially for immunocompromised individuals at higher risk of severe outcomes. Tonix aims to leverage its capabilities to expand its COVID-19 therapeutic pipeline.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced a sponsored research agreement with Boston Children's Hospital to evaluate TNX-1500, an Fc-modified anti-CD40L monoclonal antibody, for preventing graft-versus-host disease (GvHD) after hematopoietic stem cell transplantation (HCT). The study, led by Dr. Leslie Kean, aims to assess TNX-1500's effectiveness in modifying GvHD progression in animal models, supporting future human trials. A Phase 1 study for TNX-1500 is expected to start in the first half of 2023, targeting improved treatment outcomes for hematologic malignancies.
Tonix Pharmaceuticals (Nasdaq: TNXP) presented data on TNX-801, a live horsepox virus vaccine, at the World Vaccine and Immunotherapy Congress. CEO Seth Lederman emphasized that TNX-801 could offer better protection against monkeypox and smallpox compared to modern vaccines. The company plans to initiate a Phase 1 clinical study in Kenya in H1 2023 and has reported positive data from non-human primates showing complete protection from monkeypox. TNX-801 is based on the 1976 horsepox strain, suggesting it has a close genetic link to Edward Jenner's original smallpox vaccine.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) presented data on its fully human anti-SARS-CoV-2 monoclonal antibody platform at the World Antiviral Congress 2022. Collaborating with Columbia University, the project aims to enhance understanding of immune responses to COVID-19 and develop targeted therapeutics. CEO Seth Lederman emphasized the necessity for second-generation monoclonal antibody treatments due to new variants and declining efficacy of existing ones. The company is exploring rapid development of novel therapeutics from patient samples, showcasing its capabilities in biologics manufacturing.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its participation in the A.G.P. Biotech Conference, scheduled for November 30 - December 1, 2022. The conference will be virtual, allowing management to engage in investor meetings. Interested investors can arrange meetings via the conference coordinator. Tonix focuses on developing therapeutics for CNS disorders, rare diseases, immunology, and infectious diseases. Key products under development include TNX-102 SL for fibromyalgia and TNX-1300 for cocaine intoxication. Upcoming studies include Phase 2 trials for various treatments in 2023.
Tonix Pharmaceuticals (Nasdaq: TNXP) announced that CEO Seth Lederman will present at the World Vaccine and Immunotherapy Congress 2022 in San Diego from November 28 to December 1, 2022. The presentation, titled ‘Showcase 1: Early Development of Smallpox & Monkey Pox Vaccines,’ is scheduled for December 1 at 10:40 a.m. PT. Tonix focuses on developing therapeutics for various diseases, with key candidates in CNS disorders, rare diseases, and infectious diseases. Future studies for multiple product candidates are anticipated in 2023.
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