Tevogen Bio CEO Ryan Saadi and CSO Neal Flomenberg share White House concerns about emerging COVID-19 variants and impact on immunocompromised patients, and express commitment to accelerate development of company’s investigational COVID-19 therapy

• Tevogen Bio CEO and CSO share concerns of the White House and President Joe Biden who stated, “New variants may make some existing protections ineffective for the immunocompromised” and promise to do everything in their power to accelerate development and manufacturing of its investigational therapy, TVGN-489
• A comprehensive review by the company’s R&D team found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes
• Tevogen is exploring all options including Emergency Use Authorization (EUA) for TVGN-489 for the treatment of COVID-19 in immunocompromised patients
• TVGN-489 targets were specifically selected across the entire viral genome to avoid anticipated mutational susceptibility under evolutionary pressure

WARREN, N.J.–(BUSINESS WIRE)–#celltherapies—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology today expressed that its CEO Dr. Ryan Saadi and Chief Scientific Officer Dr. Neal Flomenberg share President Biden’s concerns that emerging COVID-19 variants “may make some existing protections ineffective for the immunocompromised” and reconfirm the company’s commitment to accelerate the development and manufacturing of its investigational COVID-19 treatment, TVGN-489.

A comprehensive review, completed by the company’s Research and Development team, found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes, which appear to have the ability to evade some existing prophylactic options and immunity.

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 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.

“It’s concerning that, so far, all of Omicron’s subvariants have shown increased transmissibility and high immune escape potential,” said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer. “Even if the average person gets only a mild case, the risks to the elderly, the infirm, and the immunocompromised subsets of the population remain significant. These are the patient populations on whom we will focus our upcoming trials. However, I’m greatly encouraged by the durability of TVGN-489’s targets from the original COVID strains which reached the U.S. through the Delta and Omicron variants. The fact that TVGN-489 targets are spread across the entire COVID genome, rather than just within the spike protein, helps reduce target loss due to mutation from immunologic pressure. Moreover, TVGN-489 can remain active even if one target should be lost, which is very different from many of the other therapeutic approaches to prevent or treat COVID-19,” added Dr. Flomenberg. “We are rapidly expanding our capabilities to address the needs of these higher vulnerability groups.”

“It is everyone’s responsibly to step up during a moment of crisis, and for those of us in the medical innovation industry, it is our moral obligation. And we will do everything in our power to save as many lives as we can,” said Tevogen CEO and Nobel Peace Prize nominee Ryan Saadi, M.D., M.P.H.

“With new variants emerging, especially in the fall and winter months, we need to do everything possible to speed up the process of getting potentially life-saving therapeutics to our most vulnerable populations,” said Victor Sordillo, Mayor of Warren, NJ Township, and a member of Tevogen’s Corporate Advisory Board.

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.

Contacts

Media:
Katelyn Joyce

Corporate Communications Lead

T: 1 877 TEVOGEN, Ext 709

[email protected]