Tonix Pharmaceuticals Holdings Inc. (NASDAQ:TNXP) has enrolled its first participant in the observational PRECISION study, TNX-002. The study examines immune response to coronavirus in healthy volunteers that are asymptomatic or have recovered from COVID-19.
The PRECISION study divided into two
This research is part of its ongoing collaboration with Columbia University, focusing on antibody and T-cell responses to the SARS-CoV-2. The study has been designed into two projects. Dr. Ilya Trakht, who is an Associate Research Scientists at the university, will lead the first study focusing on isolation and characterization of therapeutic human monoclonal antibodies to COVID-19. Dr. Sergei Rudchenko, an Assistant Medical Sciences Professor and Columbia University Vagelos College of Physicians and Surgeons, will lead the second study. The study has been designed to create DNA aptamer-based anti-idiotypes to select monoclonal antibodies; the first project will identify. These aptamers have the potential of identifying biomarkers for protective SARS-CoV-2 immunity. They could also lead to expedited precision medicine-based vaccines for protecting against COVID-19.
Seth Lederman, the CEO and President of the company, said that the PRECISION study data will help guide research in determining the appropriate vaccine or treatment on an individual basis. He added that the study could also guide enrolment of the right subjects for COVID-19 clinical trials. This includes future human trials for the company’s live replicating, attenuated SARS-CoV-2 vaccine candidate, TNX-1800, that has been designed to offer lasting T cell immunity.
Tonix’s COVID-19 vaccine candidate derived from the horsepox virus
The company’s TNX-1800 vaccine candidate is a live modified horsepox virus vaccine meant for percutaneous administration. It has been designed to show the Spike protein of the COVID-19, causing the SARS-CoV-2 virus and also elicit a major T-cell response. Live replicating orthopoxviruses such as horsepox are easily re-engineered to show foreign genes and have been studied as vaccine development platforms because of their large exogenous DNA inserts packaging capacity and also precise exogenous gene inserts expression. They also offer the ability to generate insert constructs, strong immunogenicity quickly, and are easily manufactured at scale.
