CHATHAM, N.J.—Tonix Pharmaceuticals, Inc. Holding Corp. announced today that the company has completed the purchase of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center for the accelerated development and manufacturing of vaccines, including vaccines for COVID-19.
“We are excited to have taken the first step in vertically integrating more of our development activities, but even more importantly, adding a manufacturing capability for clinical trial quality vaccines,” said Seth Lederman, M.D., president and chief executive officer of Tonix Pharmaceuticals. “We believe this provides Tonix with a competitive advantage, especially in the current COVID-19 environment in which more domestic development and manufacturing capacity is needed.”
Tonix Pharmaceuticals expects the facility to be operational within 24 months, with single-use bioreactors and purification suites with equipment for Good Manufacturing Practice production of vaccines for clinical trials. When fully operational, the facility will also have the capability of producing sterile vaccines in glass bottles. Research, development and supporting analytical capabilities are also planned.
Tonix is currently developing potential COVID-19 vaccines based on two live viral vector platforms: horsepox and bovine parainfluenza (BPI) virus. Four potential COVID-19 vaccines in development are based on the horsepox vector, and two potential vaccines are based on the BPI vector. Tonix expects to report results from an efficacy study of its lead COVID-19 candidate, TNX-1800, before the end of the year.
The TNX-1800 vaccine is based on horsepox, which is believed to be similar to the live attenuated single dose smallpox vaccine developed by Dr. Edward Jenner more than 200 years ago. TNX-1800 is designed to express the SARS-CoV-2 spike protein and to elicit a predominately T cell response in order to provide long term immunity and prevent forward transmission.
“As a nation, we have a mandate to reduce our reliance on off-shore resources and we hope our plans become a siren call for others to join in fulfilling this objective. We expect that the U.S. government will maintain a sustained interest in pandemic preparedness based on the devastating effect of COVID-19 on the health of the U.S. population, on education and on the economy,” added Lederman.