Tevogen Bio Publishes Positive Phase I Results for TVGN 489 in Blood Advances

WARREN, N.J., June 25, 2024 – Tevogen Bio Inc. (Nasdaq: TVGN), a clinical-stage immunotherapy biotech firm, revealed promising results from its phase I clinical trial of TVGN 489, an investigational immunotherapy targeting SARS-CoV-2. The trial data, published in Blood Advances, underscores the potential of TVGN 489, which employs allogeneic Cytotoxic CD8+ T lymphocytes (CTLs) to combat COVID-19.

In the study, twelve high-risk patients, including a considerable portion who were immunocompromised or had preexisting cancers, were administered a single infusion of one of four escalating doses of TVGN 489. Notably, the product consisted of 68.5% SARS-CoV-2-specific CD8+ CTLs. The phase I trial compared the outcomes of these patients with an observational group of eighteen individuals who received standard care, totaling 30 participants.

The trial yielded several key observations:
- TVGN 489 was well-tolerated across all four dosages.
- Nasal swab PCR data demonstrated significant viral reduction, with 88% or greater viral elimination in 92% of patients by day four, and over 99% viral elimination in all patients by day fourteen.
- No disease progression or development of Long COVID was observed in the treatment group, which included several immunocompromised individuals.
- TVGN 489 did not impede the development of the body’s natural anti-SARS-CoV-2 immune responses.
- T-cell receptor beta (TCRβ) analysis indicated the persistence of donor-derived CTLs in recipients through the six-month follow-up period.

An unexpected finding was the sustained presence of TVGN 489 CTLs in all patients tested over the six months. Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer, noted the significance of this persistence, which is often linked with disease control. He emphasized the importance of further investigating the reasons behind this persistence and its potential implications.

Dr. Dolores Grosso, Tevogen’s Global Clinical Development Lead, expressed optimism about the trial outcomes. She highlighted the importance of confirming the safety of TVGN 489 and further evaluating its efficacy in subsequent trials involving elderly and immunocompromised COVID-19 patients, who are at higher risk of adverse outcomes.

Ryan Saadi, CEO of Tevogen Bio, underscored the broader potential of T cell therapies developed through Tevogen’s technology platform, ExacTcell™. Saadi believes that this platform represents a significant breakthrough, with the potential to mainstream cell therapy by providing off-the-shelf T cell treatments for a range of applications in virology, oncology, and neurology.

Tevogen Bio is dedicated to harnessing the power of CD8+ cytotoxic T lymphocytes to develop genetically unmodified precision T cell therapies. The company aims to address unmet medical needs in treating infectious diseases, cancers, and neurological disorders. Tevogen's leadership emphasizes the importance of ensuring patient access to these innovative therapies through advanced scientific methods and novel business models. With positive safety data from its initial clinical trials and a robust intellectual property portfolio, Tevogen Bio is poised to advance its development programs and bring new therapeutic options to patients.

Tevogen's team comprises experienced industry professionals and distinguished scientists with extensive backgrounds in drug development and global product launches. The company’s leadership is focused on making personalized therapeutics more accessible, believing that innovative business models are essential to sustaining medical advancements.