Tevogen Bio Reports Its Investigational SARS-CoV-2 Specific T Cell Therapy, TVGN-489, Retains Activity Against the Dominant JN.1 Variant

Tevogen Bio Holdings ('Tevogen Bio') (Nasdaq: TVGN), today 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 JN.1 strain based on a review of this variant’s protein sequences.

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, including the currently dominant JN.1 strain and newer JN.1 strains, show that 96% of these CTLs remain active against the current circulating variants.

In January of 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.

"We remain committed to developing therapeutic solutions for patients who are highly vulnerable to developing poor outcomes when infected with SARS-CoV-2," said Tevogen CEO Dr. Ryan Saadi. "I am also highly optimistic about the potential of TVGN 489 to bring much needed relief to millions of Long Covid patients," he added.

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.