• Tevogen’s ExacTcell platform is designed to produce off-the-shelf, genetically unmodified, allogeneic cytotoxic CD8+ T lymphocyte (CTL) products that can be targeted against malignancies and viruses.
• TVGN 489 is the first clinical product from Tevogen's ExacTcell platform.
• TVGN 489 is an off-the-shelf, genetically unmodified, allogeneic CTL product with precise targets across the SARS-CoV-2 genome.
• The safety and feasibility of TVGN 489 was successfully tested in high-risk ambulatory patients with COVID-19.

Tevogen Bio is pleased to announce that it will present the proof-of-concept clinical trial results of TVGN 489, the company's first clinical product from its ExacTcell platform, at the 5th Annual Allogeneic Therapies Summit in Boston, MA.

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Tevogen Bio ExacTcell Platform (Graphic: Business Wire)

ExacTcell, Tevogen’s precision T cell platform, utilizes CD8+ Cytotoxic T Lymphocytes (CTLs) also known as Killer T Cells, one of nature’s most powerful weapons against cancer and infection. Unlike currently available genetically engineered T cell therapies, the ExacTcell platform is based on careful selection of naturally occurring T cells that recognize targets of interest from the body’s native T cell receptor pool to provide enhanced safety. CD8+ CTLs in ExacTcell based products target multiple and distinct antigens to overcome potential mutational challenges, such as TVGN 489.

• TVGN 489 precisely targets multiple areas across the COVID-19 genome - not just the Spike protein.
• To date, these TVGN 489 targets, which were identified early in the pandemic, have persisted through the most recent Omicron derived SARS-CoV-2 variants.
• Conducted at Thomas Jefferson University Hospital in Philadelphia, the trial assessed the safety and feasibility of TVGN 489 when given at one of four escalating doses to patients who were at high-risk for COVID-19-related complications due to their age and other medical conditions.
• Each patient in the treatment arm received a single infusion of TVGN 489.

Positive Proof-of-Concept Clinical Trial Results:

• No dose-limiting toxicities or significant adverse events related to TVGN 489, including Cytokine Release Syndrome, were observed in any patient at any dose level.
• Every patient in treatment arm returned to their baseline health status within 14 days.
• Following TVGN 489 treatment, no incidence of COVID-19 reinfection or Long COVID was observed in any treated patient at the time of the six (6) month follow up.
• Symptom improvement was reported by all patients receiving TVGN 489 within 2 to 3 days of treatment, which corresponded to a significant decrease in COVID-19 viral load on nasal swab PCR testing in the majority of patients.

"TVGN 489 has shown promise as a safe therapy in our proof-of-concept trial, warranting continued development for patients who are vulnerable to poor COVID-19 outcomes, such as the immune-compromised, elderly, and infirm," stated Dolores Grosso, DNP, the trial's Principal Investigator.

"These proof-of-concept trial results have illustrated the immense potential of Tevogen's ExacTcell platform, providing a foundation for the future product development for other viral diseases and various cancers. In addition, we are exploring the potential of TVGN 489 for the treatment and prevention of Long COVID," said Neal Flomenberg, MD, Tevogen's Chief Scientific Officer.

“We believe that cell therapies are expected to be the norm, not the exception,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “Tevogen aspires and is designed to be the very first biotech to achieve commercial success and patient affordability through advanced science and efficient business models.”

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, precise candidate targets on viral or malignant cells are selected in advance for T cell sensitization and effector functions with the goal of overcoming the mutational escape capacity of cancer cells and viruses while limiting cross-reactivity.

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 provide access to the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections. The ability to administer TVGN-489 in the outpatient setting and the ongoing work by Tevogen scientists to use this product in diverse patient populations, highlights Tevogen Bio’s commitment to patient accessibility.

About Tevogen Bio

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. 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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