Benzinga | Nov 22, 2021 04:09PM EST

Tonix Pharmaceuticals Announces Publication Of Paper On Antiviral SARS-CoV-2 Inhibitor, TNX-3500, In JCI Insight

Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced the publication of "Sangivamycin is highly effective against SARS-CoV-2 in vitro and has favorable drug properties," in JCI Insight. The paper includes in vitro studies that show sangivamycin, the active pharmaceutical ingredient in the Company's (TNX-3500) product candidate, is a potent antiviral against SARS-CoV-2, the cause of COVID-19, and suppresses viral replication in tissue culture with greater efficacy than remdesivir, the active pharmaceutical ingredient of Gilead Sciences, Inc.'s Veklury(r). When tested in combination with remdesivir, both drugs had additive rather than competitive effect against SARS-CoV-2. The new data show that TNX-3500 has similar low nanomolar antiviral activity in laboratory-based assays against multiple variants of SARS-CoV-2, including the Delta variant. The article can be accessed at https://insight.jci.org/articles/view/153165.



"We are excited to have the results of this study published, as it demonstrates Tonix's commitment to helping fight COVID-19 and other viral disorders," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix. "We believe that TNX-3500's potency on SARS-CoV-2 inhibition in tissue culture and its tolerability in humans from prior clinical studies support the pursuit of TNX-3500 for further clinical development as a potential COVID-19 therapeutic."

In April 2021, Tonix entered into an exclusive worldwide licensing agreement with OyaGen, Inc. (www.oyageninc.com) to develop TNX-3500 for the treatment of COVID-19 and potentially other viral infections. OyaGen, Inc. discovered sangivamycin's broad-spectrum antiviral effect against Ebola virus, Lassa virus and orthopoxviruses ( https://doi.org/10.3390/v13010052) through a collaborative research agreement with National Institute of Allergy and Infectious Disease/National Institute of Health (NIAID/NIH) Integrated Research Facility (IRF-Frederick) at Fort Detrick, Maryland, and the recent findings on SARS-CoV-2 are a product of this collaboration.

Dr. Harold Smith, President and CEO of OyaGen, Inc. stated, "The findings reported in our paper are exciting and reveal significant new understanding of the broad-spectrum antiviral activity of sangivamycin and its in vitro activity. Given the rapid global spread of the Delta variant of SARS-CoV-2, we are encouraged that the high potency of sangivamycin against multiple variants of SARS-CoV-2 may provide a much-needed medical countermeasure against current and future variants of coronaviruses. The data produced through a collaborative research agreement with the IRF-Frederick together with prior safety studies in cancer clinical trials suggest that TNX-3500 may be effective in clinical settings and perhaps may enhance the efficacy of other therapeutics through combination antiviral therapy. We are excited to be working with Tonix on the development of TNX-3500 for the treatment of COVID-19."

Tonix intends to conduct further nonclinical animal studies prior to submitting an Investigational New Drug application (IND) and initiating a Phase 1 clinical study.