Tevogen Bio to Study its Investigational COVID-19 T Cell Therapy in Immunocompromised Patients Who are Unable to Benefit From Currently Available Prevention or Treatment Options
Tevogen’s investigational precision T cell product, 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.
The immunocompromised COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies are amongst the most vulnerable.
Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, half of whom were immunosuppressed patients, Tevogen now plans to move forward with a clinical trial to study the efficacy of its product in this patient population.
Tevogen’s research pipeline includes cell therapies for treatment of COVID-19, long COVID, viral-induced cancers and neurologic diseases, including multiple sclerosis; and several non-virally induced cancers.
December 7, 2022
WARREN, N.J., December 7, 2022 – Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology today announced its intention to study the potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in immunocompromised patients.
“I’m greatly encouraged by the POC trial experience of TVGN 489 and highly optimistic that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of high-risk COVID patients.” said Dr. Dolores Grosso, Tevogen’s Clinical Development Lead.
There exists a significant unmet need for the treatment of COVID-19 in immunocompromised patients. Currently, there are very few treatment options that have not been impacted by variants or are suitable for this patient population due to possible medication interactions. A comprehensive review, completed by the company’s Research and Development team, led by Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer, 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. “The lack of treatment options places immunocompromised patients at higher risk of developing poor outcomes if infected with SARS-CoV-2,” said Dr. Flomenberg.
“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 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 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.
T: 1 877 TEVOGEN, Ext 701