Tevogen Bio has concluded dosing of the first cohort of subjects in the proof-of-concept clinical trial of its experimental immunotherapy, TVGN-489, to treat Covid-19 in the high-risk population.
TVGN-489 has SARS-CoV-2 particular cytotoxic CD8+ T lymphocytes (CTLs), which can potentially identify targets spread across the complete viral genome.
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Tevogen Bio noted that such targeted CTLs can potentially detect and destroy virally infected cells.
The single centre, open-label trial will assess the safety, efficacy and optimal dose of TVGN-489 in adults aged 18 years and above with Covid-19.
It is recruiting subjects who are at increased risk of severe disease advancement either because of their advanced age or any underlying health issues.
The outcomes from subjects who receive TVGN-489 in Arm A will be compared with people receiving the standard of care in Arm B of the trial.
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By GlobalDataSo far, no dose-limiting toxicities or treatment-linked side effects were reported in any of the three subjects who received a single low-dose infusion of the drug candidate.
These participants were observed in the hospital for four days before being discharged and daily for another ten days in the at-home setting.
The second group of subjects in the study will be given a higher dose of the experimental immunotherapy and monitored in the same manner.
The trial will have up to four dosing levels of TVGN-489.
Tevogen CEO Ryan Saadi said: “Preclinical data of TVGN-489 exhibited strong antiviral activity against SARS-CoV-2, and we are hopeful that the proof of concept study will demonstrate the viability of our investigational T cell therapy to address the significant unmet need in treating Covid-19 patients who are at-risk for more severe outcomes.”
In May this year, the company reported data from a preclinical study where TVGN-489 showed robust antiviral activity against SARS-CoV-2.
