Pharma Focus Asia

Tonix Pharmaceuticals Enters into Exclusive Worldwide Licensing Agreement with OyaGen

Tuesday, April 20, 2021

Tonix Pharmaceuticals Holding Corp., a clinical-stage biopharmaceutical company, and OyaGen, Inc. (OyaGen), a pre-clinical biotechnology research company, announced an exclusive worldwide licensing agreement for an antiviral inhibitor of SARS-CoV-2, TNX-3500 (sangivamycin, formerly OYA1), for the treatment of COVID-19 and potentially other viral disorders. The active ingredient of TNX-3500 has been studied for safety in humans in prior studies on cancer patients at the U.S. National Cancer Institute but has not been approved for marketing in any jurisdiction.

“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's President and Chief Executive Officer. “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.”

Harold Smith, PhD, Chief Executive Officer and founder of OyaGen and professor of biochemistry and biophysics at the University of Rochester, School of Medicine and Dentistry said, “TNX-3500 has shown strong dose-dependent antiviral activity against live SARS-CoV-2 virus in cell culture infectivity studies. TNX-3500 was demonstrated to be approximately 65 times more potent in head to head comparisons at inhibiting SARS-CoV-2 than remdesivir, the active ingredient of Veklury®. In addition, combining TNX-3500 and remdesivir has demonstrated additive activity against SARS-CoV-2 in cell culture infectivity studies. These studies are from unpublished results from OyaGen’s collaborative research with the National Institutes of Allergy and Infectious Diseases Integrated Research Facility (NIAID-IRF), part of the National Institutes of Health. TNX-3500 inhibits the replication of SARS-CoV-2 and may have other mechanisms of action that affect viral particle release from infected cells.”

Dr. Smith continued, “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.”

Under the terms of the agreement, Tonix has been granted an exclusive license from OyaGen for technology 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 treating COVID-19 as necessary to support regulatory approval.

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