Tevogen Bio Confirms Efficacy of TVGN 489 Against FLiRT Strains of SARS-CoV-2

Tevogen Bio Holdings Inc. ("Tevogen" or "Tevogen Bio"), a clinical-stage biotech pioneer listed on Nasdaq under the symbol TVGN, is making significant strides in immunotherapy for oncology, neurology, and virology. The company recently announced that its investigational therapy, TVGN 489, retains efficacy against the new FLiRT strains of SARS-CoV-2. These strains, which evolved from the JN.1 variant, are currently the most dominant in the United States.

TVGN 489 is designed to combat COVID-19 and Long COVID in high-risk patients. It comprises Cytotoxic CD8+ T lymphocytes (CTLs) that target several SARS-CoV-2 proteins. Continuous monitoring by Tevogen has shown that 95% of these CTLs remain effective against the FLiRT variants, including the KP.2 strain, which is currently prevalent.

In January 2023, Tevogen shared promising data from a phase I clinical trial. High-risk patients infected with the delta, omicron 1, and omicron 2 variants were treated with TVGN 489, which was manufactured in May 2021. The trial reported no significant dose-limiting toxicities or adverse events. Notably, all patients showed rapid clinical improvement and a significant reduction in the viral load from their nasal swabs within 14 days. Dr. Dolores Grosso, Tevogen’s Global Clinical Development Lead, stated that these results would be evaluated in later-stage trials, and the efficacy of TVGN 489 against emerging variants would continue to be monitored.

Tevogen's CEO, Dr. Ryan Saadi, emphasized the company's commitment to developing therapeutic solutions for high-risk populations. He also expressed optimism about TVGN 489’s potential to alleviate the significant burden of Long COVID, an area where little progress has been made despite substantial government investment.

A key feature of TVGN 489 is its manufacture using the ExacTcell™ platform. This innovative approach selects multiple peptides across the viral genome as targets for CTLs, ensuring that the therapy remains effective even if some targets mutate. Unlike treatments that focus solely on the spike protein, TVGN 489 targets the entire viral genome, offering broader protection. This comprehensive targeting reduces the need for frequent updates to the formulation, unlike monoclonal antibodies, which often lose effectiveness due to rapid mutations.

Tevogen Bio is dedicated to harnessing CD8+ cytotoxic T lymphocytes to develop precision T cell therapies for infectious diseases, cancers, and neurological disorders. The company aims to address significant unmet medical needs through advanced science and innovative business models. Tevogen's leadership believes that patient accessibility and sustainability are crucial in the current healthcare landscape.

Tevogen has reported positive safety data from its proof-of-concept clinical trials and holds key intellectual property assets, including three granted patents and twelve pending patents, two of which involve artificial intelligence. The company is led by a team of experienced industry veterans and distinguished scientists with extensive drug development and global product launch experience. They believe that personalized therapeutics represent the future of medicine and that disruptive business models are necessary to sustain medical innovation.

In summary, Tevogen Bio is making significant progress in the field of immunotherapy, particularly with its investigational therapy TVGN 489. The promising results from early clinical trials and the innovative approach to targeting the SARS-CoV-2 virus position Tevogen as a key player in developing effective treatments for COVID-19 and Long COVID.