FDA Clears Tevogen Bio’s IND Application for CTL COVID-19 Treatment
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.
Source: Tevogen Bio, Business Wire
Drug Solutions Podcast: Gliding Through the Ins and Outs of the Pharma Supply Chain
November 14th 2023In this episode of the Drug Solutions podcast, Jill Murphy, former editor, speaks with Bourji Mourad, partnership director at ThermoSafe, about the supply chain in the pharmaceutical industry, specifically related to packaging, pharma air freight, and the pressure on suppliers with post-COVID-19 changes on delivery.
