Tevogen Bio to Study Therapeutic Potential of its Investigational COVID-19 T Cell Therapy in Long COVID

• Tevogen’s investigational precision T cell product, TVGN 489, is designed to address the unmet need of COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies and potentially those with Long COVID, where there are no currently available treatment options
• Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, Tevogen intends to explore the potential of this therapy for the treatment of Long COVID
• Tevogen’s research pipeline includes off-the-shelf, allogeneic genetically unmodified precision CD8+ T Lymphocyte therapeutics for the treatment of immunocompromised patients with COVID-19, patients with other serious viral infections, viral-induced cancers, several non-virally induced common cancers, and neurologic diseases, including multiple sclerosis
• Tevogen’s inventions are designed to overcome both cost and geography related patient access barriers and aims to transform cancer treatment by developing cell therapies as first-line options

Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology announced today its intention to study potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in Long COVID. The finding that none of the patients in the TVGN 489 Proof-of-Concept (POC) trial, treated for their initial COVID infection, developed Long COVID to date is leading Tevogen to explore the potential of TVGN 489 to also treat Long COVID.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and hopeful that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of Long COVID patients.” said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer.

“Anyone that knows someone who has been impacted by this debilitating disease understands the importance of advancing science to alleviate the suffering from Long COVID,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “I’m hopeful that our innovative T cell technology will eventually offer accessible immunotherapies to millions suffering from viral infections, cancers and other diseases with high unmet need.”

TVGN-489 is highly purified cytotoxic CD8+ T lymphocytes (CTLs) designed to detect and kill SARS-CoV-2 infected cells. These allogeneic genetically unmodified CTLs are enriched and expanded in the lab and recognize proteins from across the entire SARS-CoV-2 genome, not just the spike protein.

In July 2022, TVGN-489 completed proof-of-concept clinical trial enrollment with zero treatment-related adverse events. Patients treated were infected with a range of all COVID variants at the time, from Delta through Omicron BA.5. Additionally, each patient had co-morbidities rendering them high risk and 50 percent of those additionally met the definition of being immunocompromised.

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic 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 the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

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.

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 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 several 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,” and “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 therefrom.

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