Tevogen Bio has commenced the fourth and final dose level in an open-label clinical trial of its investigational T cell therapy, TVGN-489, to treat Covid-19 patients who are at increased risk.
A purified, genetically unmodified SARS-CoV-2-specific cytotoxic CD8+ T lymphocyte (CTL) product, TVGN-489 could identify targets spread across the complete viral genome.
The trial will assess the safety and optimal dose of its cell therapy in high-risk Covid-19 patients aged 18 years and above with predefined high-risk criteria or those aged 65 years or above with or without priorly detected comorbid conditions.
Subjects treated with the investigational product will be compared to those who receive standard of care within the context of the trial.
Subjects in the third cohort were given a single 1 x 106cells/kg dose of TVGN-489, a dosing level greater than the first and second cohorts.
So far, no dose-limiting toxicities or treatment-associated adverse events, including cytokine release syndrome (CRS), were reported in any of the arms.
In addition, all subjects in the three cohorts had a correction of lymphopenia, which is a speedy return to baseline in lymphocyte levels, analysed as a secondary outcome measure.
The subject enrolment in the study is anticipated to conclude in the second quarter of this year.
Tevogen CEO Ryan Saadi said: “Our next-generation T cell technology maintains the promise of developing target-specific cell therapies in oncology, virology, and neurology for large patient populations without requiring specialized medical facilities.
“Additionally, I’m pleased to share that the company plans to study TVGN-489 for the prevention of Long Covid.”
In November last year, the company completed dosing of the first cohort of participants in the proof-of-concept trial of TVGN-489 to treat Covid-19 in the high-risk population.
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