Tevogen Bio Initiates Final Dose Level in Proof-of-Concept Clinical Trial of its Investigational T cell Therapy for High-Risk COVID-19 Patients
Trial has advanced to the fourth and final dose escalation cohort with no dose-limiting toxicities observed to-date
Tevogen’s investigational T cell product is genetically unmodified and target-specific
The enrollment is expected to conclude in the second quarter of 2022
June 7, 2022
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.
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Corporate Communications Lead