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Rebecca Lumley
22 Jun 2022

Tonix strives for pandemic readiness with new US manufacturing facility

The company's goal is to design and test new vaccines for novel pathogens within 100 days of a potential pandemic threat 

Vaccines for monkeypox, smallpox and COVID-19 are among some of the products that will be developed by Tonix Pharmaceuticals at its new clinical-scale manufacturing facility in North Dartmouth, Massachusetts.  

The clinical-stage biopharma company officially launched its Advanced Development Center (ADC) with a ribbon cutting ceremony on Tuesday. Tonix plans to develop vaccines against infectious diseases at the new facility using its recombinant pox virus platform technology, which it says is ‘rapidly deployable for addressing potential novel or emerging pathogens.’  

The 45,000 sq ft facility features single-use bioreactors and purification suites with equipment for GMP production of vaccines for clinical trials, including the capability to produce sterile vaccines in glass bottles. It has been designated a Biosafety Level 2 site, a Centers for Disease Control and Prevention label which means the microbes there pose moderate hazards to laboratorians and the environment.   

According to Tonix Pharmaceuticals CEO Seth Lederman, the facility will accelerate development of vaccines targeting infectious diseases.  

He commented: ‘The ADC greatly enhances our ability to progress our pipeline of vaccines for infectious diseases, including monkeypox, smallpox and COVID-19. We believe that the recombinant pox virus platform technology underlying our key vaccines in development, TNX-801, TNX-1840 and TNX-1850, coupled with our capabilities at the Tonix R&D Center (RDC) for research and development, will be rapidly deployable for addressing potential novel or emerging pathogens, with simplified distribution and administration, relative to modified mRNA-based vaccines.’ 

Lederman said the company’s goal is to ‘be able to design and test new recombinant pox virus vaccines against novel pathogens within the 100 days of recognition of a potential emerging pandemic threat’, noting that this timeline meets criteria set out by the White House Office of Science and Technology Policy.  

Tonix’s portfolio features a range of investigational new drugs or biologics that are progressing through clinical trials. These include TNX-102 SL, a candidate in mid-Phase 3 development for the management of fibromyalgia, and TNX-102 SL, which is being developed to treat Long COVID.  

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