Tonix Pharmaceuticals Holding Corp and OyaGen, Inc. 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.
TNX-3500 (sangivamycin) has demonstrated broad-spectrum antiviral activity in laboratory-based assays against the coronaviruses SARS-CoV-2 and MERS-CoV. Sangivamycin also demonstrated that it acts as a dual target specific antiviral against filoviruses such as Ebola virus in cell culture infectivity studies. TNX-3500 was studied in the U.S. at the National Cancer Institute (NCI), part of NIH, as an investigational new drug for treating cancer in the 1960s. Studies at that time demonstrated safety in nonhuman primates and human adults when dosed daily or weekly. TNX-3500 was demonstrated in studies in mice to persist in tissues for greater than 12 days following a single dose. Its long half-life in tissues suggests that a single dose or weekly dosing may be sufficient for antiviral treatments.
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.
