Tevogen Bio Initiates Final Dose Level in Proof-of-Concept Clinical Trial of its Investigational T cell Therapy for High-Risk COVID-19 Patients

WARREN, N.J.--(BUSINESS WIRE)-- Tevogen Bio, a late-stage biotechnology company specializing in developing cell and gene therapies in oncology, neurology, and virology, today announced it has initiated the fourth and final dose level of its investigational T cell therapy for high-risk COVID-19 patients.

The open-label clinical trial is designed to study the safety and optimal dose of its investigational target-specific T cell therapy when given to high-risk COVID-19 patients (age ≥ 18 years with predefined high-risk criteria) or those who are 65 or older (with or without previously identified comorbid conditions). Participants receiving the investigational therapy will be compared to patients receiving standard of care within the context of the study.

Each patient in the third cohort received a single infusion (1 x 10⁶cells/kg) of TVGN-489, a higher dosing level than the first (1 x 10⁵cells/kg) and second cohorts (3 x 10⁵ cells/kg). No dose limiting toxicities or treatment-related adverse events, including Cytokine Release Syndrome (CRS), have been observed to date in any of the cohorts. In addition, as a secondary outcome measure, all patients in the three cohorts experienced a correction of lymphopenia, which is the rapid return to baseline in lymphocyte levels.

“Given the observed safety profile of the last three cohorts, the Jefferson Health Institutional Review Board’s (IRB) Data & Safety Monitoring Committee has approved dose escalation to the fourth and final dosing level of TVGN-489,” said Principal Investigator of the trial, Dolores Grosso, DNP, CRNP, of Jefferson University Hospitals. Dr. Grosso added that genomic sequencing revealed that patients in the third cohort were infected with Omicron BA.2, BA.2.9, and BA.2.12.1 variants as opposed to the second cohort of patients who were infected with the Omicron BA.1 variant and the first cohort of patients who were infected with the Delta variant.

Tevogen CEO Ryan Saadi, M.D., M.P.H., said, “Our next generation T cell technology maintains the promise of developing target-specific cell therapies in oncology, virology, and neurology for large patient populations without requiring specialized medical facilities. Additionally, I’m pleased to share that the company plans to study TVGN-489 for the prevention of Long COVID.”

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased specificity to eliminate malignant and viral infected cells, while allowing healthy cells to remain intact. Targets are selected in advance with the goal of overcoming mutational capacity of cancer cells and viruses.

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

The company’s lead product, TVGN-489, is currently in a clinical trial for high-risk COVID-19 patients at Jefferson University Hospitals in Philadelphia. TVGN-489 is a highly purified, genetically unmodified SARS-CoV-2-specific cytotoxic CD8+ T lymphocyte (CTL) product, which is designed to detect targets spread across the entire viral genome.

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost and completion of preclinical studies and clinical trials; risks related to regulatory review and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions herefrom.

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