Tonix Pharmaceuticals Holding Corp. is a clinical-stage biopharmaceutical company headquartered in Chatham, New Jersey. The company was founded in 2007 and then later went public in 2013. Tonix Pharmaceuticals is led by Seth Lederman who has been CEO since co-founding the company. Mr. Lederman was an Associate Professor at Columbia University for more than 2 decades before venturing into the private sector. Tonix Pharmaceuticals is his second venture, the first was bought out after developing an effective treatment for colorectal cancer. The company operates through three facilities located in Massachusetts, Maryland, and Montana.
The two east-coast facilities are the R&D center and the Advanced Development Center while manufacturing is located in Montana. The Maryland facility is rated BSL-2 with some areas rated BSL-3 which allows for the handling of live viruses. The Massachusetts facility is intended to enhance the company’s R&D and analytics capabilities as well as facilitate vaccine production at the clinical trial scale. The Montana facility will support Phase III trials as well as the mass production of approved treatments.
Tonix Pharmaceuticals focuses on discovering, acquiring, developing, and licensing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering across a wide spectrum of ailments and treatments. Among them is COVID-19 for which the company has several products in development.
Its portfolio includes immunology, rare disease, infectious disease, and central nervous system (CNS) product candidates. The types of diseases the company targets are widely occurring but hard to treat so breakthroughs of any kind could be significant sources of income. The company has several candidates in pre-clinical and clinical trials with two standouts that are on track for FDA approval. Resilient, a treatment for Fibromyalgia, and Prevail, a treatment for long-COVID, entered Phase III and Phase II trials in 2022.
The immunology portfolio includes treatments for organ transplant rejection, autoimmunity, and cancer, and several in this group have shown efficacy against multiple indications. The company’s infectious disease pipeline includes several promising treatments for viruses afflicting the world today. The TNX-80 vaccine is intended to prevent smallpox and monkeypox while TNX-1840 and TNX-1850 are live virus vaccines to fight COVID-19, as will TNX-3500 and TNX-102, which are small molecule antiviral drugs.
Tonix Pharmaceuticals CNS portfolio includes small molecules and biologics to treat pain, neurologic, psychiatric, and addiction including Resilient, which is in mid-Phase 3 development for the management of fibromyalgia. Other products in the pipeline are TNX-1900 which is in development for the prevention of migraine headaches and TNX-1300 which is designed to treat cocaine intoxication.