Tonix Pharma (TNXP) says plans advancing to construct commercial-scale manufacturing facility to develop and manufacture vaccines in Bitterroot Valley

June 24, 2021 4:13 PM EDT
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Dr. Seth Lederman, CEO of Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, said today that plans are advancing to construct a commercial-scale manufacturing facility to develop and manufacture vaccines in the Bitterroot Valley.

During a roundtable discussion today in Hamilton hosted by the Ravalli County Economic Development Authority (RCEDA), Lederman and community leaders announced a new public/private sector collaboration between Ravalli County and Tonix Pharmaceuticals that will bring more high-tech bioscience jobs to the Bitterroot Valley. Lederman said he was pleased that the Hamilton City Council voted in April to ensure that critical infrastructure will be available to Tonix once the construction phase is complete. Tonix’s new manufacturing site will be constructed on 44 acres of land designated by Ravalli County as a Target Economic Development District (TEDD), which allows for tax money generated at the site to be used for building infrastructure inside the district.

Attendees included Lederman, Rocky Mountain Lab Associate Director Dr. Marshall Bloom, Hamilton Mayor Dominic Farrenkopf, Ravalli County Commissioner Greg Chilcott, and RCEDA board chair Ryan Oster. The panel met to discuss recent developments in a longstanding effort to turn southwest Montana into a renowned biotech corridor. Tonix joins the U.S. National Institutes of Health’s Rocky Mountain Laboratories (RML) in Hamilton, which is an internationally recognized leader in vaccine development and virology research. GlaxoSmithKline (GSK) also has a vaccine manufacturing facility in Hamilton.

Lederman has said that once the facility is completed, Tonix expects to create many high-tech bioscience jobs. The new Montana facility is intended to develop and produce Tonix's vaccine candidates, including TNX-1800, a potential COVID-19 vaccine.

“One of the things that the COVID-19 pandemic exposed was major shortcomings in U.S. domestic vaccine development and manufacturing capabilities,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Tonix is striving to be a pioneer in American made vaccine development and production. We believe it is vital to bring these skills and high-tech jobs back to the U.S. both in the fight against the COVID-19 pandemic and it’s long lasting effects, and to prepare for prospective future pandemics. Building our new Montana facility demonstrates our dedication to the development of our vaccines and creating good American jobs. We are excited to be at the forefront of this exciting time in domestic manufacturing and biotech in Montana, and we look forward to continued collaboration with the community partners here in the Bitterroot valley.”

“This is an unprecedented opportunity for economic development in Montana, and Ravalli county in particular,” said Julie Foster, the Executive Director of the Ravalli County Economic Development Authority (RCEDA). “We’re excited that we were able to work in collaboration with the city, county and the folks at Tonix to move this project forward and bring more good jobs to the Bitterroot Valley.”

In addition to a COVID-19 vaccine, Tonix is also developing a diagnostic test for T cell immunity to COVID-19 ,as well as an antiviral therapeutic for COVID-19. Tonix also announced earlier this week that it plans to develop TNX-102 SL, currently in phase 3 development for fibromyalgia, as a potential treatment for Long COVID Syndrome. The disease's symptoms include pain, sleep disturbance, fatigue, and brain fog, which are also seen in fibromyalgia. Tonix plans to meet with the U.S. Food and Drug Administration (FDA) in the third quarter of 2021 to determine the design of a pivotal phase 2 study. Some studies have indicated that Long COVID Syndrome, officially called Post-Acute Sequelae of COVID-19 (PASC), can occur in more than 30% of COVID-19 patients that have recovered.

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