TNXP stock exploded higher in after-hours trading on September 28, 2020, after the company announced the purchase of a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19.
Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, completed the purchase a 40,000 square foot facility in Massachusetts to house its new Advanced Development Center (ADC) for accelerated development and manufacturing of vaccines, including vaccines for COVID-19.
Tonix 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, including when fully operational, the capability of producing sterile vaccines in glass bottles. In addition, research, development and supporting analytical capabilities are planned.
Tonix currently is 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 based on the BPI vector. Before year end the company expects to report results from an efficacy study of its lead COVID-19 candidate based on horsepox platform, TNX-1800, in which non-human primates are being challenged with SARS-CoV-2, the virus that causes COVID-19. 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, which led to the eradication of smallpox. 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.
“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. 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,” commented Seth Lederman, M.D., Tonix’s President and Chief Executive Officer. “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.”
The facility is located in the New Bedford Business Park, but the facility is in a section of the park that is actually located in the Town of Dartmouth, Massachusetts. The two municipalities work together to accommodate businesses located in the Dartmouth portion of the park as the roads are inaccessible through Dartmouth and municipal services are provided by the City of New Bedford.
On September 15, 2020, Tonix Pharmaceuticals announced that the first patient was enrolled in the observational COV-LOGIC study, a study of humoral and cellular immune responses to SARS-CoV-2 in volunteers who have recovered or remain asymptomatic after exposure to COVID-19. The research is part of an ongoing and broader collaboration between Tonix and Southern Research to develop and conduct animal testing of Tonix’s TNX-1800, which is a live replicating, attenuated virus vaccine designed to protect against COVID-19. The COV-LOGIC study is an observational multi-cohort sample collection study designed to collect the blood and nasopharyngeal swabs from individuals who have, and have not, been previously infected with SARS-CoV-2, or who have been intimately exposed to persons confirmed to have been infected with SARS-CoV-2, in order to analyze their antibody titers and T-cell responses to specific proteins of SARS-CoV-2 and to detect SARS-CoV-2 RNA which may be persistent in the nasopharynx at the time of sampling. For those individuals in whom viral RNA is detected during initial sampling, repeat blood and NP swab samples may be collected to examine temporal virus/immune response dynamics. In addition, blood will be collected for DNA extraction and exome sequencing in order to assess whether host genetic factors might influence these humoral or cellular responses or viral persistence.