Tevogen Bio Announces Unique T Cell Vaccine Under Development and Files Patent with the USPTO

Rhea-AI Summary

Tevogen Bio (TVGN) has filed a new patent with the USPTO for an innovative T cell vaccine under development. Unlike traditional vaccines focusing on B cell response, this vaccine aims to stimulate T cell responses targeting the entire viral genome, similar to their lead product TVGN 489. The approach is designed to combat mutation risks by targeting multiple viral segments.

The vaccine development is powered by Tevogen.AI's PredicTcell technology for peptide identification. Initially focused on national security and U.S. military biological threat protection, the vaccine's application could be expanded based on needs. The development aligns with Tevogen's previously announced topline forecasts of $1 billion each for their Oncology and Specialty Care divisions.

Positive

• Patent filing for innovative T cell vaccine targeting entire viral genome
• Development aligns with $1 billion revenue forecast for each division
• Potential military and national security applications with room for expansion

Negative

• Vaccine still in early development phase
• No immediate revenue impact from this development

Insights

Financial Analyst

Tevogen Bio's patent filing for a novel T cell vaccine represents a strategic expansion of their product pipeline and intellectual property portfolio. The company is leveraging its existing proprietary AI platform (Tevogen.AI) and PredicTcell technology to develop this vaccine with a differentiated mechanism targeting entire viral genomes rather than specific proteins.

While the announcement signals R&D progress, investors should note this appears to be in early development stages with an initial focus on national security applications and military use cases. The company explicitly stated this initiative won't impact previously announced $1 billion topline forecasts for each of their Oncology and Specialty Care divisions, suggesting this development is not expected to contribute to near-term revenue.

From a strategic perspective, targeting military/security applications first provides a potential streamlined path to market with a stable customer base, though with initially commercial scale. The technology's approach of targeting entire viral genomes to address mutation concerns is scientifically sound in principle but will require substantial clinical validation.

This announcement represents standard pipeline expansion rather than a transformative development. The filing of a patent application is merely an initial step in securing intellectual property protection with no guarantee of approval. Minimal financial details or development timelines were provided, indicating considerable development work remains ahead.

Biotech Specialist

Tevogen's T cell vaccine approach represents a technically distinct strategy compared to conventional vaccines. Traditional vaccines primarily stimulate B cells to produce antibodies against specific viral proteins, leaving them vulnerable to evasion through mutations. By targeting T cell responses against multiple targets across an entire viral genome, similar to their lead candidate TVGN 489, Tevogen's approach could theoretically provide more comprehensive and durable protection.

The integration of their AI platform (Tevogen.AI) with their PredicTcell technology suggests they're using computational methods to predict optimal T cell targets across viral genomes. This approach could potentially identify conserved regions less prone to mutation while filtering out targets that might trigger autoimmunity or ineffective responses.

However, T cell vaccine development faces unique challenges. Unlike antibody responses, T cell responses are MHC-restricted and vary significantly between individuals. Achieving broad population coverage requires careful epitope selection. Additionally, delivery systems for effectively stimulating T cell responses often differ from those optimized for antibody production.

The initial focus on national security applications is strategically sound, as this pathway may have different regulatory considerations than standard consumer vaccines. The CEO's emphasis on transparency acknowledges the challenges of vaccine hesitancy in broader markets. While the concept has scientific merit, we lack critical details about development stage, specific viral targets, delivery platform, or preliminary efficacy data that would better establish its potential value and timeline.

• Vaccine is intended to stimulate T cell responses against targets across the entire genome of the selected virus, similar to company’s lead product candidate TVGN 489, to mitigate the risk posed by mutations.
• Approach may provide prophylaxis to viral infections and would be complementary to current treatment under development by Tevogen Bio.
• Powered by Tevogen Bio’s artificial intelligence initiative, Tevogen.AI.
• The company hopes to address public concerns about inoculation during vaccine development.
  

WARREN, N.J., March 10, 2025 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech company, today announced the filing of a new patent with the U.S. Patent and Trademark Office (USPTO) for its under-development T cell vaccine. Unlike many vaccines that primarily induce a B cell response, Tevogen Bio’s design aims to leverage the Company’s proprietary Tevogen.AI-powered PredicTcell technology to identify peptides which stimulate a T cell response.

A key differentiator of this vaccine is its ability to target the entire viral genome, much like the Company’s lead product candidate, TVGN 489. This strategy helps mitigate the risk posed by mutations that might otherwise evade immune detection when only one protein or segment of the virus is targeted.

The development of this vaccine leverages Tevogen Bio’s established technology and will not impact previously announced launch year topline forecasts of $1 billion each for Tevogen Bio Oncology and Specialty Care.

“While our T cell vaccine development currently prioritizes national security and equipping the U.S. military against biological threats, its use can be expanded to broader applications if circumstances call for it,” said Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio. “The success of any public health measure relies on the trust and support of the people it is meant to protect, and just as I value open dialogue with our retail shareholders, I am personally committed to ensuring transparency and active public involvement throughout the development process,” added Dr. Saadi.

About Tevogen Bio

Tevogen Bio is a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies to treat infectious disease and cancers, aiming to address the significant unmet needs of large patient populations. Tevogen Bio leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen Bio has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents, nine pending US and twelve ex-US pending patents, two of which are related to artificial intelligence.

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen Bio’s leadership believes that accessible personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer; Tevogen’s plans to expand its efforts in artificial intelligence; Tevogen’s ability to develop additional product candidates; Tevogen’s use of funds from the grant; and the potential receipt of additional future grants. 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; the outcome of any legal proceedings that may be instituted against Tevogen; 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; the ability to develop, license or acquire new therapeutics; that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; 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

FAQ

What makes Tevogen Bio's new T cell vaccine (TVGNW) different from traditional vaccines?

It targets the entire viral genome to stimulate T cell responses rather than primarily inducing B cell responses, helping mitigate mutation risks.

How much revenue is Tevogen Bio projecting for its Oncology and Specialty Care divisions?

Tevogen Bio projects $1 billion in topline forecasts for each division.

What technology is Tevogen Bio using to develop its new T cell vaccine?

The vaccine development utilizes Tevogen.AI's PredicTcell technology for peptide identification.

What is the primary initial target market for Tevogen Bio's new T cell vaccine?

The vaccine development primarily targets national security and U.S. military biological threat protection.