Tonix hopes for COVID-19 drug tonic as it pens OyaGen antiviral pact

Tonix Pharmaceuticals is opening an early-stage antiviral asset deal with OyaGen as the pair targets COVID-19.

The research and license pact, financials of which were not made public, focuses on the antiviral inhibitor of SARS-CoV-2, TNX-3500 (aka sangivamycin, formerly OYA1), which Tonix believes can hit back against the pandemic virus and “potentially other viral disorders.” 

The active ingredient of the drug has, in fact, been studied for safety in humans in prior research on cancer patients at the U.S. National Cancer Institute.

New York-based OyaGen says very early tests of TNX-3500 have shown it to be 65 times more potent in head-to-head comparisons at inhibiting SARS-CoV-2 than remdesivir, the active ingredient of Gilead’s Ebola-cum-COVID drug Veklury. Combining the two also saw “additive activity against SARS-CoV-2 in cell culture infectivity,” according to the preclinical biotech, though these results are from as yet unpublished trials.

Whether this remains true in late-stage clinical or real-world settings will now be determined by Tonix. Many new and repurposed drugs have failed to win through over the past year; Tonix and OyaGen will now hope to buck that trend.

“We are excited to expand our pipeline and we look forward to developing TNX-3500 as a potential treatment for COVID-19 and emerging variants,” said Seth Lederman, M.D., Tonix president and CEO. “TNX-3500 is in the pre-Investigational New Drug (IND) phase of development with encouraging early data from cell culture infectivity studies with SARS-CoV-2. 

“We believe that its potency on SARS-CoV-2 inhibition in tissue culture and its tolerability in humans from prior studies suggests that TNX-3500 may qualify for expedited clinical development.”

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“We’re delighted to partner with Tonix on the development of TNX-3500 because we believe Tonix to be ideally capable to bring this program to the clinic and position it for worldwide commercialization in the rapidly evolving and highly competitive area of SARS-CoV-2 inhibitors,” added Harold Smith, Ph.D., CEO and founder of OyaGen and professor of biochemistry and biophysics at the University of Rochester's School of Medicine and Dentistry.

Under the terms of the agreement, Tonix has been granted an exclusive license from OyaGen for tech and patents related to TNX-3500 and other related compounds. Tonix will conduct further studies to test the safety and efficacy of TNX-3500 in COVID-19.