Tonix to Develop Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

Tonix Pharmaceuticals Holding Corp. announced it has entered into a research collaboration and option agreement with Columbia University focused on studying the immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic. The research collaboration will focus on T cell and antibody responses to SARS-CoV-2 (CoV-2), the virus that causes COVID-19 at the cellular level including human monoclonal antibodies and anti-idiotypes. The research is designed to fill in important gaps in understanding the detailed immune responses to COVID-19, and to provide a foundation upon which to target vaccines and therapeutics to appropriate individuals by precision medicine.

The two principal investigators for the collaboration are Ilya Trakht, Ph.D., Associate Research Scientist and Sergei Rudchenko, Ph.D., Assistant Professor of Medical Sciences at Columbia University Vagelos College of Physicians and Surgeons. Dr. Trakht’s project will study T cell and antibody responses in a variety of ways, including at the cellular level by stimulating T cells in vitro with CoV-2 antigens and by generating fully human monoclonal antibodies against CoV-2. The project, directed by Dr. Trakht, has the potential to lead to the isolation and characterization of therapeutically relevant fully human monoclonal antibodies to CoV-2. Dr. Rudchenko’s project will generate DNA aptamer-based anti-idiotypes to certain of the monoclonal antibodies identified by Dr. Trakht. Such aptamers have the potential to identify biomarkers for protective CoV-2 immunity and to lead to accelerated precision medicine-driven vaccines designed to protect against COVID-19.

Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, said, “We expect that more than one COVID-19 vaccine will ultimately be approved by the Food and Drug Administration (FDA), and a challenge for future research will be to determine which vaccine is appropriate for each individual. Data from this collaboration will provide a roadmap and tools to potentially guide these recommendations. This work may also guide the selection of appropriate individuals for COVID-19 vaccine trials, such as for Tonix’s TNX-1800, based on a live replicating vector platform, which is designed to confer durable T cell immunity. It is also possible that new COVID-19 vaccines can designed which will be tailored to individuals by precision medicine. We are excited to work with our collaborators at Columbia University on these precision medicine technologies and also to potentially develop new monoclonal antibody therapeutics.”

Dr. Trakht said, “T cell responses to SARS-CoV-2 have only recently been reported, so there is much that we hope to learn and to contribute to the understanding of the systemic immune response to COVID-19. We are excited to exploit our fully human monoclonal antibody system to characterize the antibody response to SARS-CoV-2 infection and the potential for developing antibody-based immunotherapeutics.”

Dr. Rudchenko said, “The anti-idiotype aptamer tools that we plan to develop will characterize the immune responses in healthy people who have recovered or were asymptomatic from SARS-CoV-2 infection, which are relevant for developing therapeutics and vaccines. A goal for future research will be to use these tools to distinguish SARS-CoV-2-specific immunity in COVID-19 patients who suffered poor outcomes. My colleague, Dr. Trakht’s system to make human monoclonal antibodies is particularly well suited to evaluate individuals’ antibody responses at a high level of detail in the context of accelerating precision medicine approaches to vaccines and therapeutics.”

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