Tonix Pharmaceuticals Holding (NASDAQ: TNXP) is a biopharmaceutical company with marketed products and a pipeline of development candidates. Tonix’s TNX-801, a live-virus vaccine candidate, could potentially offer a more viable solution to address the growing global mpox crisis. TNX-801 shows promise because it appears to align with the preferred target product profile (“TPP”) recently issued by the World Health Organization (“WHO”). The TPP emphasizes a well-tolerated, single-dose vaccine that can be administered, shipped and stored in Africa and around the world.
Jynneos(R) and ACAM2000(R), two FDA-approved vaccines for mpox, do not fully meet WHO’s TPP. Thus, TNX-801 potentially offers a much-needed alternative. Preclinical trials of the vaccine candidate showed that it provides single-dose protection against the newly spreading strain of the monkeypox virus called Clade I. Additionally, TNX-801 is suitable for making lyophilized versions that are expected to be stable at ambient temperatures for about 8 hours, helping with logistics in various parts of the world. “Beyond its alignment with WHO’s single-dose requirement, TNX-801 seems to offer multiple competitive features that could position it as a viable contender in the global fight against mpox,” the press release reads.
To view the full press release, visit https://ibn.fm/JpqZ1
About Tonix Pharmaceuticals Holding Corp.
Tonix is a fully integrated biopharmaceutical company focused on developing, licensing and commercializing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s development portfolio is focused on central nervous system (“CNS”) disorders. Tonix’s priority is to submit a New Drug Application (“NDA”) to the FDA in the second half of 2024 for TNX-102 SL, a product candidate for which two statistically significant Phase 3 studies have been completed for the management of fibromyalgia. The FDA has granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction. Tonix’s CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication and has Breakthrough Therapy designation. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (“CD40L” or “CD154”) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix also has product candidates in development in the areas of rare disease and infectious disease. Tonix Medicines, the company’s commercial subsidiary, markets Zembrace(R) SymTouch(R) (sumatriptan injection) 3 mg and Tosymra(R) (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. For more information about Tonix, visit www.tonixpharma.com.
NOTE TO INVESTORS: The latest news and updates relating to TNXP are available in the company’s newsroom at http://ibn.fm/TNXP
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