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The IND for Tevogen Bio's TVGN-489, an allogeneic COVID-19-specific cytotoxic T lymphocyte, received rapid clearance from FDA.
FDA cleared Tevogen Bio’s investigational new drug application for its investigational COVID-19 treatment, TVGN-489, which is an allogeneic COVID-19-specific cytotoxic T lymphocyte (CTL), the company announced on July 12, 2021.
This clearance allows Tevogen Bio to begin clinical trials, which will evaluate the safety of TVGN-489 in high-risk COVID-19 patients and will also measure viral load and long-term immune response as secondary endpoints. In addition, the results of the patients receiving TVGN-489 will be compared to patients treated with the current standard of care. The previous preclinical study for TVGN-489 demonstrated strong antiviral activity against SARS-CoV-2.
Programmed to detect targets from the entire viral genome, TVGN-489 is highly purified SARS-CoV-2 specific cytotoxic CD8+ T lymphocytes. The CTLs are anticipated to detect and kill virus-infected cells, which then allows the body to replace them with healthy, uninfected cells.