No dose-limiting toxicities or treatment-emergent adverse events have been reported.
The second, higher-dose cohort has finished dosing in the phase 1 study (NCT04765449) of TVGN-489, an investigational allogeneic SARS-CoV-2 specific CD8+ T-cell therapy.
The cell therapy seems to be well-tolerated so far in the first cohort of patients dosed with 1 x 105 cells/kg, and now the second cohort dosed with 3 x 105 cells/kg. There have been no reports of dose-limiting toxicities or treatment-related adverse events (AEs) such as cytokine release syndrome.
“Our observations regarding the safety of this investigational T cell immunotherapy in the second cohort of patients are very encouraging and provide the basis for continued optimization of dosing in future cohorts. We remain optimistic about the possibility of TVGN-489 serving as a useful tool in the fight against COVID-19 and its emerging variants,” principal investigatorDolores Grosso, DNP, CRNP, Research Assistant Professor, Jefferson Health, said in a statement.1
The single center, open-label study is being conducted at Jefferson University Hospitals in Philadelphia. It is enrolling participants at a high risk of severe COVID-19 due to underlying health conditions or advanced age in 2 arms, 1 treated with TVGN-489 and 1 treated with standard-of-care, to evaluate the safety and optimal dose of TVGN-489.
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The trial has 4 planned dose-escalation cohorts, the third of which is currently enrolling. Enrollment is expected to conclude early in the second quarter of 2022. Genomic sequencing revealed that all patients in the second cohort were infected with the Omicron variant, while all patients in the first cohort were infected with the Delta variant.
“Tevogen’s off-the-shelf allogeneic T cell technology overcomes the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing. Our breakthrough innovation opens the possibility of bringing the benefits of T cell therapeutics to large patient populations at unprecedented speed, without the need for specialized medical facilities, such as those required for CAR-T,” Ryan Saadi, MD, chief executive officer, Tevogen, added to the statement.
TVGN-489 is a highly purified, cytotoxic CD8+ T lymphocyte cell therapy designed to detect targets spread across the entire viral genome rather than only spike proteins. The company was granted a patent for their method of preparing and manufacturing TVGN-489 in January 2022.2
“Omicron’s extensive mutations and its subsequent ability to evade antibodies highlights the importance of Killer T cells, which can still recognize and eliminate virus-infected cells,” Saadi said in an earlier statement.2 “Millions among us suffer from inadequate T cell response for various reasons. After two years of the pandemic and witnessing the challenges posed by the ever-evolving virus, we must explore scientific options beyond our current approaches. CTL therapeutics for large patient populations is not an easy undertaking, but Tevogen’s ability to manufacture hundreds of doses from a single donor gives me hope,” Saadi added.
In January, Tevogen also announced their intention to develop Epstein-Barr virus-specific CD8+ cytotoxic T lymphocyte, off-the-shelf cell therapies for the treatment of multiple sclerosis following the recent study published in Science that revealed the strong connection between the virus and neurodegenerative disease.3,4