Tonix Pharmaceuticals Holding Corp. (Tonix or the Company), a clinical-stage biopharmaceutical company, announced it has completed the acquisition of its new research and development center (RDC) located in Frederick, Md. The approximately 48,000 square foot facility will support Tonix’s expanding infectious disease pipeline, including:
- TNX-1800 – a live virus vaccine designed to protect against COVID-19
- TNX-801 – a live virus vaccine designed to protect against smallpox and monkeypox
- TNX-3500 – a small molecule antiviral under development to treat COVID-19
- TNX-2100 – a peptide based skin test to measure functional T cell immunity to SARS-CoV-2
Tonix purchased the RDC from Southern Research, a collaborating partner on TNX-1800 and TNX-801 development.
The center is operational with a dedicated staff of scientists and technicians. The main building was constructed as a biosafety level (BSL) -3 facility but has been operating at BSL-2. Tonix plans to make appropriate upgrades and seek certification for BSL-3 so that research may be conducted on live SARS-CoV-2- and other pathogens.
The RDC in Frederick, Md. will complement Tonix’s Advanced Development Center (ADC) being constructed in New Bedford, Mass., and its Commercial Manufacturing Center (CMC) planned in Hamilton, Mont. The ADC will house laboratories dedicated to process analytical development and pilot manufacturing of the Company’s vaccine candidates for clinical trials. The CMC is expected to support commercial scale manufacturing of vaccine products.
“The establishment of the RDC is a significant milestone for Tonix and aligns with our strategic focus to support and grow our pipeline of vaccines and antiviral therapeutics,” stated Seth Lederman, M.D., President and Chief Executive Officer of Tonix. “We believe that this strategy will enable Tonix to develop vaccines and therapeutics to address the current COVID-19 pandemic, and to be prepared to efficiently combat potential novel or emerging pathogens, termed ‘Disease X’, that could impact society in the future. We believe that the recombinant pox virus platform technology underlying TNX-1800 and TNX-801, coupled with our capabilities at the RDC and ADC, will be rapidly deployable for addressing Disease X, with simplified distribution and administration, relative to modified mRNA based vaccines. Our 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, consistent with the criteria recently set forth by the White House Office of Science and Technology Policy.”