Tevogen Underscores the Importance of Precision Immunotherapies, Including TVGN 489 for Vulnerable Individuals Infected with SARS-CoV-2

Rhea-AI Summary

Tevogen (NASDAQ:TVGN) emphasized the ongoing importance of SARS-CoV-2 treatments for immunocompromised individuals, highlighting their TVGN 489 investigational therapy. The treatment, developed using the ExacTcell platform, showed promising results in clinical trials.

Key trial findings revealed that TVGN 489 achieved >99% viral elimination in all patients by day 14, with CTLs persisting through six months of follow-up. The therapy demonstrated faster symptom resolution compared to standard care and was well-tolerated across all dose levels. Notably, the treatment's targets remain unaffected by mutations, including the current XFG variant.

Positive

• Clinical trial showed >99% viral elimination in all patients by day 14
• Treatment demonstrated faster symptom resolution compared to standard care
• CTLs persisted in patients through six months of follow-up
• Therapy targets remain unaffected by mutations, including current XFG variant
• Treatment was well-tolerated at all four dose levels

Negative

• Company will need to raise additional capital to execute business plan
• Limited operating history poses execution risks
• Faces regulatory approval uncertainties for commercial development

Insights

Clinical Immunology Specialist

Tevogen's TVGN 489 shows promising results for immunocompromised COVID-19 patients with complete viral clearance and no disease progression.

Tevogen's press release highlights significant clinical trial results for their TVGN 489 therapy, an allogeneic SARS-CoV-2-specific T-cell treatment developed using their ExacTcell platform. What makes this approach noteworthy is that it targets the entire viral genome rather than just the spike protein, which has important implications for effectiveness against variants.

The trial data published in Blood Advances revealed several important findings. First, high-risk patients (half of whom were immunocompromised) who received a single infusion demonstrated faster symptom resolution compared to standard care. More impressively, the treatment led to >99% viral elimination in all patients by day 14, with no disease progression or Long COVID observed in the treatment group. The treatment was well-tolerated at all four tested dose levels.

Perhaps most promising from an immunological perspective is that the CTLs (Cytotoxic T Lymphocytes) persisted for six months in treated patients, suggesting potential for durable protection. This is particularly valuable for immunocompromised individuals who struggle to mount effective immune responses against pathogens.

The company emphasizes that TVGN 489's targets remain unaffected by viral mutations, including the current XFG variant. This is a critical advantage over treatments targeting only the spike protein, which can become less effective as the virus mutates. For vulnerable populations who remain at high risk despite vaccination campaigns, this approach could represent an important therapeutic option with year-round relevance.

WARREN, N.J., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today highlighted the continuing need for SARS-CoV-2 treatments for individuals with weakened immune systems, who are at the highest risk of complications from the virus. TVGN 489, the Company’s investigational allogeneic SARS-CoV-2-specific Cytotoxic CD8+ T lymphocyte (CTL) immunotherapy is developed using the ExacTcell platform. It is designed to fortify anti-SARS-CoV-2 immunity in these individuals and directly eliminate the virus. The CTLs are directed against the entire viral genome rather than single protein. Publication of positive POC/dose finding clinical trial data of TVGN 489 is available through Blood Advances:

Clinical Trial Key Findings:

• The treatment arm, which included high-risk patients and half of whom were immunocompromised, received a single infusion of TVGN 489.
• As a secondary end point, treated patients demonstrated faster and more consistent symptom resolution, compared to patients in the standard of care comparative arm.
• In the treatment arm, viral elimination reached >99% in all patients by day +14; no disease progression or Long COVID was observed in the treatment arm.
• TVGN 489 was well-tolerated at all four dose levels and did not impair endogenous immune responses.
• CTLs persisted in treated patients through six months of follow-up, an encouraging finding.
• TVGN 489 targets remain unaffected by mutations, including the current XFG SARS-CoV-2 variant.

“An intact immune system is necessary to cure viral infections and TVGN 489 is designed to directly provide this immune help to individuals who need it,” said Dr. Ryan Saadi, CEO of Tevogen Bio. “This matters for cases like COVID-19 where infection is caused by a mutation-prone RNA virus. Targeting only the spike protein remains inadequate.”

“The XFG variant of SARS-CoV-2 surging now, is a reminder that COVID-19 is not limited to just the winter months and remains a threat to those with weakened immune systems," said Dr. Neal Flomenberg, Chief Science Officer at Tevogen. “Surveillance of this virus and treatment for our most vulnerable populations is now a yearlong reality.”

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.

Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K.

You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.

Contacts

Tevogen Bio Communications

T: 1 877 TEVOGEN, Ext 701

Communications@Tevogen.com

FAQ

What are the key clinical trial results for Tevogen's TVGN 489 COVID-19 treatment?

TVGN 489 achieved >99% viral elimination in all patients by day 14, showed faster symptom resolution compared to standard care, and demonstrated CTL persistence through 6 months. The treatment was well-tolerated at all dose levels.

How does Tevogen's TVGN 489 work against SARS-CoV-2 variants?

TVGN 489 targets the entire viral genome rather than single protein, making it effective against mutations, including the current XFG variant. This approach differs from treatments targeting only the spike protein.

What patient population is TVGN 489 designed to treat?

TVGN 489 is specifically designed for individuals with weakened immune systems who are at highest risk of COVID-19 complications, providing immune support through allogeneic SARS-CoV-2-specific Cytotoxic CD8+ T lymphocytes.

What are the main risks facing Tevogen's TVGN 489 development?

Key risks include the need for additional capital, regulatory approval uncertainties, limited operating history, and potential challenges in commercial development and market competition.

How long does the effectiveness of TVGN 489 treatment last?

Clinical trials showed that the Cytotoxic T Lymphocytes (CTLs) persisted in treated patients through six months of follow-up, indicating sustained effectiveness.