Tonix Pharmaceuticals Holding Corp. (TNXP) has reaffirmed its commitment to advancing the development of its live attenuated virus vaccine, TNX-801 (recombinant horsepox virus), for the prevention of mpox and other infectious diseases. The company’s stock saw significant trading volume on Friday, reaching 53.33 million shares.
Mpox, also known as monkeypox, is a viral disease affecting both humans and animals, characterized by a rash that progresses from blisters to crusts, accompanied by fever and swollen lymph nodes. The World Health Organization (WHO) declared the surge of mpox cases in various African countries a Public Health Emergency of International Concern in August 2022, marking the second such declaration in two years.
TNX-801 is a promising vaccine candidate derived from horsepox. It’s designed to provide immunity while being more tolerable than older vaccinia virus-based vaccines. This same vaccine platform, upon which TNX-801 is based, was chosen by the U.S. National Institutes of Health (NIH) for Project NextGen, where it’s used to create an engineered version expressing the spike protein of SARS-CoV-2.
Preclinical studies have shown that TNX-801 effectively protects animals against lethal exposure to the Clade 1 monkeypox virus. A single dose of the vaccine prevented clinical disease, lesions, and reduced viral shedding in the mouths and lungs of non-human primates.
“Preclinical trials demonstrate that TNX-801 combines immune protection with improved tolerability and safety compared to other vaccines based on orthopoxviruses and is administered with a single dose, which has advantages over two-dose regimens. The durability of protection from 19th-century live virus vaccinia vaccines suggests that our attenuated TNX-801 will not require multiple repeated doses at six-month intervals like mRNA vaccines. Also, the stability of live virus vaccines eliminates the need for ultra-cold storage, which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now,” said Seth Lederman, CEO.
The Bipartisan Commission on Biodefense has recently emphasized the renewed dual threats posed by a more virulent mpox epidemic and the potential re-introduction of smallpox from lab accidents or intentional releases. The National Academies of Science, in its review of smallpox preparedness, stressed the need for novel single-dose vaccines, like TNX-801, to combat smallpox.
The renewed focus on mpox and smallpox, along with the potential benefits of TNX-801, has led to increased interest in Tonix Pharmaceuticals. As of Friday’s market close, TNXP stock was up 4.01% at $0.48.
The development of TNX-801 represents a significant step towards addressing the threat of mpox and other infectious diseases. Its potential for single-dose administration, improved tolerability, and stability make it a promising candidate for widespread use, particularly in regions where access to vaccines and cold storage is limited.
