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.
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.
So 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.