Tevogen Bio Holdings Inc. announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated FLiRT strains of SARS-CoV-2 based on a review of this variant?s protein sequences. Named FLiRT to reflect amino acid changes occurring in the spike protein, these Omicron subvariants are descendent from JN.1, the previously dominant strain in the US. TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides.

TVGN 489?s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, show that 95% of these CTLs remain active against FLiRT variants, including KP.2, the current dominant strain. In January 2023, Tevogen reported positive phase I study results in which high-risk patients with the delta, omicron 1, and omicron 2 variants of COVID-19 received TVGN 489, manufactured for the trial in May of 2021.

In addition to no dose-limiting toxicities or significant treatment-related adverse events being observed in the treatment arm, all patients, regardless of variant, experienced prompt clinical improvement and a reduced amount of virus in their nasal swabs (>99 to 100% in all patients) within 14 days. ?These findings will be further assessed in planned later-stage trials and TVGN 489 will continue to be monitored for target preservation in emerging SARS-CoV-2 variants,? said Dr Dolores Grosso, DNP, Tevogen?s Global Clinical Development Lead.

TVGN 489 is manufactured using the ExacTcell? platform in which numerous peptides from across a viral genome are selected as targets for the CTLs, mitigating reductions in cytotoxicity from the loss of one target from mutation. In the case of SARS-CoV-2, the entire COVID-19 genome as opposed to just the Spike protein is targeted.

The preservation of T-cell targets across nearly five years of viral evolution avoids the need to make frequent changes to the formulation of TVGN 489 and stands in contrast to the loss of monoclonal antibody targets, which has happened far more rapidly in a number of cases.