Tevogen Bio Holdings Inc. reported publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy by the journal Blood Advances. Key Observations: Interventional arm patients, totaling twelve high-risk individuals, 50% of whom were immunocompromised, and 40% of whom were immunocompromised due to preexisting cancers, received a single infusion of one of four escalating doses of TVGN 489, a product containing 68.5% SARS-CoV-2-specific CD8+ CTLs/total cells. Symptom improvement and resolution in treatment arm patients were compared to an observational group of eighteen patients who received standard care, making a total of 30 study participants.

TVGN 489 was well-tolerated at all four doses tested. Nasal swab PCR data showed 88% or greater viral elimination in 92% of patients by day +4 and > 99% viral elimination in all patients by day +14. No progression of disease or the development of Long COVID was observed in the treatment group, despite the prevalence of immunocompromised patients.

TVGN 489 did not interfere with the development of endogenous anti-SARS-CoV-2 humoral or cellular responses. T-cell receptor beta (TCRß) analysis comparing TVGN 489 responses derived from the CTL donor versus recipients showed persistence of donor-derived CTLs through the end of the 6-month follow-up period. An unanticipated finding was the persistence of the TVG-489 CTLs in all patients tested through the end of the 6-month follow-up period.