Tevogen Reports Major Clinical Milestone: Expands HLA Coverage of its Investigational Precision T Cell Therapy for Acute and Long COVID

Rhea-AI Summary

Tevogen (Nasdaq: TVGN) announced on Nov 5, 2025 completion of T cell target identification for five additional HLA restrictions, expanding ExacTcell™ coverage beyond the initial HLA-A*02:01.

The company says the step could extend TVGN 489 access from ~25% to approximately 65% of the U.S. population. The TVGN 489 proof-of-concept trial reported 100% viral clearance, no reinfections, and no Long COVID cases in high-risk patients.

Positive

• TVGN 489 POC trial: 100% viral clearance
• POC trial reported no reinfections
• POC trial reported no Long COVID cases
• Expanded HLA coverage to ~65% US population
• Identification of five additional HLA restrictions

Negative

• No regulatory approvals yet; regulatory review risks noted
• Company may need to raise additional capital to execute plans
• Tevogen has a limited operating history per the release

Insights

Clinical and Commercial Analyst

Tevogen expands HLA coverage for its ExacTcell platform, increasing potential patient reach and reinforcing prior POC safety signals.

Tevogen reports identification of targets for five additional HLA restrictions, extending theoretical coverage from HLA-A*02:01 (~25) to approximately 65 of the U.S. population. This technical step addresses a key biological constraint—HLA diversity—so that the same off‑the‑shelf CTL product family could match more patients’ HLA types without genetic modification. The company also cites prior TVGN 489 proof‑of‑concept data showing safety and feasibility and the claimed outcomes of 100% viral clearance, no reinfections, and no Long COVID cases in that small cohort, which underpin the program’s translational rationale.

Dependencies and risks remain clear and limited to facts disclosed: expanded HLA mapping is a necessary but not sufficient milestone for broad clinical utility. The announcement does not report randomized efficacy data, regulatory milestones, manufacturing scale metrics, or confirmatory trial outcomes. The ability to convert target identification into licensed, broadly available products depends on clinical validation across diverse populations, reproducible efficacy endpoints, and scalable manufacturing capacity; each must be demonstrated in subsequent studies and submissions.

Concrete items to watch in the near term include formal clinical trial designs and endpoints for broader HLA cohorts, submission or initiation dates for follow‑up studies, and disclosed manufacturing capacity or CMC milestones that support off‑the‑shelf supply; monitor these over the next 6–24 months from Nov 05, 2025 for material readouts or regulatory steps.

• This milestone expands patient eligibility through multi-HLA targeting
• Builds on completed TVGN 489 trial demonstrating 100% viral clearance, no reinfections, and no cases of Long COVID in high-risk patients
• TVGN 489 utilizes off-the-shelf, genetically unmodified allogeneic T cells
• TVGN 489 is designed to address both acute COVID-19 infection and Long COVID

WARREN, N.J., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced a clinical milestone in the evolution of its proprietary ExacTcell™ platform: completion of T cell target identification for an additional five human leukocyte antigen (HLA) restrictions. This advancement significantly broadens the accessibility of Tevogen’s investigational precision T cell therapies by extending therapeutic reach beyond the single HLA-A*02:01 restriction used in the Company’s initial proof-of-concept (POC) clinical trial, the results of which were published in Blood Advances. That study demonstrated the safety and feasibility of Tevogen’s third-party cytotoxic T lymphocyte (CTL) therapy, TVGN 489, in high-risk patients with COVID-19.

HLA type varies widely among individuals and population groups. HLA-A*02:01 was selected for the proof-of-concept trial because it is one of the most common HLA types in the United States, present in approximately 25% of the population. Collectively, the identification of five additional HLA targets will allow the manufacture of CTLs which would extend treatment to approximately 65% of the US population, bolstering coverage for minority populations with less common HLA types.

“The selection of additional HLA targets for Tevogen’s ExacTcell products was performed with the goal of enfranchising as many patients as possible regardless of their race or ethnicity. Achieving multi-HLA coverage marks an essential step toward the path of truly universal T cell therapeutics,” said Dr. Neal Flomenberg, Chief Scientific Officer of Tevogen Bio. “This scientific progress brings us closer to a future in which patients, regardless of genetic background, can benefit from precise and durable immune-based treatments.”

The ability to treat additional patients with TVGN 489 applies to high-risk immunocompromised patients with an acute COVID-19 infection as well as those suffering from Long COVID. Long COVID affected approximately 35 million U.S. adults as of 2023 resulting in an estimated economic burden of $2.6 trillion to $3.7 trillion, encompassing lost earnings, healthcare costs, and diminished quality of life according to JAMA Network. These figures underscore the urgent need for durable, accessible solutions such as Tevogen’s investigational T cell therapies.

The ExacTcell™ platform utilizes advanced immunological screening as well as laboratory testing to identify key targets recognized by the immune system across different HLA types. With this expanded coverage, Tevogen’s next generation of T cell therapies aims to reach a much wider range of patients affected by infectious diseases and cancers.

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: 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; that Tevogen will need to raise additional capital to fully realize its business plans; 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 and subsequent filings with the SEC.

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

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/2bf7fd67-e990-400f-a1b5-46672a093364

FAQ

What did Tevogen (TVGN) announce on Nov 5, 2025 regarding HLA coverage?

Tevogen completed T cell target identification for five additional HLA restrictions, broadening ExacTcell coverage.

How much U.S. population coverage could TVGN 489 reach after the HLA expansion?

The company states the additional HLA targets could extend treatment reach to approximately 65% of the U.S. population.

What clinical results did TVGN 489 show in the proof-of-concept trial?

The published proof-of-concept trial reported 100% viral clearance, no reinfections, and no cases of Long COVID in high-risk patients.

Does the Nov 5, 2025 announcement mean TVGN 489 is approved for use?

No; the announcement describes trial results and target identification but does not indicate regulatory approval.

Will the HLA expansion improve access for minority populations for TVGN 489?

Yes; the company says the multi-HLA coverage bolsters access for minority populations with less common HLA types.

What risks did Tevogen highlight related to TVGN development and commercialization?

The release notes risks including regulatory review, the need for additional capital, and uncertainties inherent in clinical development.