An observational arm in the study included 18 patients. Credit: engin akyurt on Unsplash.

Tevogen Bio has reported positive topline data from a clinical trial of off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy TVGN 489 to treat acute, high-risk Covid-19 patients.

The proof-of-concept (POC) trial has been designed to evaluate the safety and feasibility of the company’s first clinical product of its precision T cell therapy platform, when given at one of four escalating doses.

TVGN 489 is a genetically unmodified product, with precise targets across the SARS-CoV-2 genome.

Conducted at Thomas Jefferson University Hospital in Philadelphia, the open label comparative trial treated 12 ambulatory patients with newly diagnosed Covid-19 infection.

These patients were at higher risk for infection-related complications due to advanced age or CDC-defined comorbid conditions such as lung, heart, liver, and kidney disease, diabetes, hypertension, cancer, or obesity.

An observational arm in the study included 18 patients, who also met these criteria but were not given TVGN 489 due to lack of HLA matching. They were treated with standard of care including monoclonal antibodies.

Infusion reactions, grade 4 adverse events, GVHD, marrow aplasia, neurotoxicity, and CRS were the trial’s safety endpoints, which were reviewed after each dose level.

An independent Data and Safety Monitoring Committee at Jefferson confirmed these endpoints. Internal and external Medical Monitors also confirmed and provided permission for escalating to the next dose level.

No patient in the treatment arm experienced progression of their infection and within 14 days of treatment, all patients returned to their baseline health level.

Through the follow-up period for six months, no incidences of reinfection or Long Covid were observed in any treated patient.

Tevogen founder and CEO Dr Ryan Saadi said: “Tevogen’s goal is to provide access to the vast and unprecedented potential of personalised immunotherapies for large patient populations impacted by common cancers and viral infections.

“The ability to administer TVGN 489 in the outpatient setting, and the ongoing work by Tevogen scientists to use this product in diverse patient populations, highlights Tevogen Bio’s commitment to patient accessibility.”

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