The companies also plan to develop the candidate for the treatment of other potential future viral diseases.
Clinical-stage biopharmaceutical company Tonix Pharmaceuticals has entered into an exclusive worldwide licensing agreement with OyaGen to advance SARS-CoV-2 inhibitor TNX-3500 (sangivamycin) for the treatment of coronavirus disease 2019 (COVID-19). The companies also plan to develop the candidate for the treatment of other potential future viral diseases.
So far, TNX-3500’s active ingredient has undergone human safety studies and investigations in cancer studies at the U.S. National Cancer Institute. Despite its background and use in clinical trials, TNX-3500 has not yet received marketing approval for any indication.
OyaGen has granted Tonix an exclusive license for technology and patents associated with TNX-3500, according to the terms of the agreement. Tonix has also received an exclusive worldwide license for other compounds related to TNX-3500. Tonix has agreed to coordinate and conduct additional safety and efficacy studies of TNX-3500 in COVID-19, with the goal of generating enough sufficient data to support regulatory approval.
“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 Tonix’s President and Chief Executive Officer (CEO), Seth Lederman, M.D., in a statement. “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.”
OyaGen’s CEO and Founder, Harold Smith, Ph.D., added that TNX-3500 had shown promising dose-dependent antiviral activity against the novel coronavirus in cell culture studies. In some studies, the candidate has shown to be up to 65 times more potent than remdesivir at inhibiting SARS-CoV-2. According to Dr. Smith, these studies are not yet published but come from a collaboration between OyaGen and the National Institutes of Health’s National Institutes of Allergy and Infectious Diseases Integrated Research Facility (NIAID-IRF).
“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,” said Dr. Smith.
TNX-3500 isn’t the only COVID-19 candidate on Tonix’s radar. In March, the company reported positive results from a study showing its COVID-19 vaccine candidate, TNX-1800, protected the upper and lower airways in eight non-human primates who had been exposed to SARS-CoV-2.
According to the investigators, these findings suggest the vaccine candidate can block forward transmission of the virus and stimulate long-term T cell immunity. Based on these findings, the company plans to advance TNX-1800 into Phase I clinical trials starting in the second half of this year.
In February, Tonix received a pre-IND meeting written response from the U.S. Food and Drug Administration, which offered guidance for the development and clinical testing of the company’s COVID-19 skin test TNX-2100. This skin test was designed to measure exposure to SARS-CoV-2 as well as related T cell immunity. If approved, TNX-2100 will be the first standardized laboratory test to measure T cell immune responses to the novel coronavirus responsible for COVID-19.
“We believe TNX-2100 has the potential to measure T cell immunity to CoV-2 and therefore serve as an aid to COVID-19 diagnosis to support patient care, public health surveillance and vaccine trials,” said Dr. Lederman in a statement. “Our proposed skin test has the potential to serve as: 1) a biomarker for cellular immunity and protective immunity; 2) a method to stratify participants in COVID-19 vaccine trials by immune status; 3) an endpoint in COVID-19 vaccine trials, and 4) a biomarker of durability of vaccine protection.”
