• No dose-limiting toxicities or significant treatment-related adverse events were observed for any patient at any dose level

Tevogen Bio, a late stage clinical biotechnology company specializing in the development of cell and gene therapies in oncology, neurology, and virology, today announced that it completed enrollment in the Proof-of-Concept clinical trial of the company’s lead investigational product, TVGN-489, for elderly or high-risk ambulatory COVID-19 patients.

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the SARS-CoV-2 genome. The open-label clinical trial was designed to study the safety and optimal dose of TVGN-489 when given to ambulatory patients with newly diagnosed COVID-19 infection who were at higher risk for infection-related complications. Patients are considered high risk due to comorbid conditions such as heart, lung, liver, and kidney diseases, hypertension, diabetes, cancer, obesity or older age (≥ 65 years) with or without comorbid conditions. The study was conducted at Thomas Jefferson University Hospital in Philadelphia.

Patients received one of four escalating dose levels, with enrollment completed for all levels in nine months. Patients treated earlier in the trial were infected with the Delta variant of COVID-19, with subsequent patients having Omicron and its subvariants of COVID-19. No dose-limiting toxicities or significant treatment-related adverse events, including Cytokine Release Syndrome (CRS), were observed for any patient at any dose level.

“Concluding patient enrollment in this trial is an exciting milestone and I believe a promising step forward in the advancement of potential new treatments for high risk patients with COVID-19,” said Principal Investigator of the trial, Dolores Grosso, DNP, CRNP, of Jefferson University Hospitals.

“Completing this trial will allow us to proceed quickly with further testing of this product in a variety of additional patient groups, including those suffering from Long COVID,” said Tevogen’s Chief Scientific Officer, Neal Flomenberg, M.D.

"We are extremely pleased to report the successful completion of patient enrollment in the TVGN-489 Proof-of-Concept clinical trial and are incredibly grateful for the trial patients, research and development team, investigators, as well as our partners at Thomas Jefferson University Hospital for completing this clinical trial. We are looking forward to full review of the data in the coming weeks,” said Tevogen CEO Ryan Saadi, M.D., M.P.H.

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 virally infected cells, while allowing healthy cells to remain intact. Multiple 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220801005232/en/