Tevogen Bio has reported positive safety data following the conclusion of subject enrolment in the proof-of-concept clinical trial of its T cell therapy, TVGN-489, in elderly or ambulatory Covid-19 patients at increased risk.
The open-label trial is designed to analyse the safety and optimal dose of the therapy in ambulatory Covid-19 patients who were at greater risk for complications associated with the infection.
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It was carried out at Thomas Jefferson University Hospital in Philadelphia, US.
Patients are deemed at increased risk due to comorbid conditions such as lung, heart, liver and kidney ailments, diabetes, cancer, hypertension, obesity or aged 65 years or above with or without comorbid conditions.
Trial subjects were given one of four escalating doses of the therapy with enrolment concluded for all levels in nine months.
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At any dose levels tested in the trial, no dose-limiting toxicities or substantial treatment-associated adverse events, including cytokine release syndrome (CRS), were reported in any trial subject.
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By GlobalDataA lead investigational therapy of the company, TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product.
It is claimed to have activity against various targets across the genome of the SARS-CoV-2 virus.
Tevogen CEO Ryan Saadi said: “We are extremely pleased to report the successful completion of patient enrolment in the TVGN-489 proof-of-concept clinical trial and are incredibly grateful for the trial patients, research and development team, investigators, as well as our partners at Thomas Jefferson University Hospital for completing this clinical trial.
“We are looking forward to a full review of the data in the coming weeks.”
In November last year, the company concluded the dosing of the first cohort of subjects in the proof-of-concept trial of TVGN-489 to treat Covid-19 in high-risk patients.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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