WARREN, N.J., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, shared the company’s ambition to address the Long COVID crisis as its leadership met with Congress on Capitol Hill last week.

“It was an honor to meet with congressional teams in Washington, D.C., to address the urgent challenge of Long COVID and present Tevogen Bio’s proprietary ExacTcell™ technology as a promising solution to this escalating crisis, which is impacting both individual patients and the broader economy," said Ryan Saadi, MD, MPH, founder and CEO of Tevogen Bio. He continued, "We are pleased with our rapid progress and notable achievements, including our precision T cell technology, recently published clinical trial results, and our robust intellectual property portfolio, all of which are critical milestones in our efforts to develop lifesaving immunotherapies for large patient populations."

Within 18 months of its inception, Tevogen Bio advanced its lead product candidate, TVGN 489, a genetically unmodified, off-the-shelf investigational T cell therapeutic for acute SARS-CoV-2 infections, from discovery to the clinical phase. Tevogen Bio’s leadership highlights its unique business model, which is both faster and cost-efficient, potentially serving as a blueprint to drive sustainable innovation and maintain the U.S.'s competitive edge in the biotech sector. With the ongoing unmet need for effective treatments of acute SARS-CoV-2 in vulnerable populations, such as the immunocompromised, those undergoing cancer treatment, or suffering from Long COVID, Tevogen Bio believes TVGN 489 has the potential to be a breakthrough solution.

Key Achievements:

• In June of 2020, Tevogen Bio is founded and launched its proprietary ExacTcell technology, designed to create accessible and disease-specific cellular immunotherapies.
• Tevogen Bio is granted 3 U.S. patents by 2022; there are currently 9 additional patents pending, including 2 for Artificial Intelligence, and 12 international applications filed.
• Tevogen Bio is recognized as the highest valued biotech unicorn of 2022, with an independent $4.2 billion valuation.
• By 2023, positive proof-of-concept clinical trial results are announced for TVGN 489, Tevogen Bio’s allogeneic CD8+ T cell therapy for high-risk SARS-CoV-2 patients. No dose-limiting toxicities or significant adverse events were reported, and secondary endpoints show rapid reduction of viral load, highlighting the potential of the therapy.
• Tevogen.AI is introduced to create artificial intelligence solutions for greater patient accessibility and quicker innovation while decreasing operating cost. Recently, Tevogen.AI has joined the Microsoft for Startups program gaining access to experts and resources from a world-leading AI company.
• On February 15, 2024, Tevogen Bio celebrates its public debut by ringing the Nasdaq Opening Bell, marking its first day of trading on the public market.
• Tevogen Bio is now included in the Russell 3000® Index, reflecting its growing presence and impact in the biotech industry.
  

Kirti Desai, CFO of Tevogen Bio, highlights, “We believe Tevogen's intellectual property assets, including 3 granted patents, have significant market value that is not currently reflected in the financial statements of the company. US GAAP rules relating to valuation of intangible assets do not permit the company to write up the internally developed intangible assets to its fair market value. We believe that a proper assessment of the company's enterprise value should include consideration of its intellectual property assets.”

Intellectual Property:

Tevogen Bio received two granted patents in December 2021 and one in January 2022 from the United States Patent and Trademark Office (USPTO) for Covid-19 Peptide Specific T-Cells and Methods of Treating and Preventing Covid-19.

• Patent Number 11207401
• Patent Number 11219684
• Patent Number 11191827
  

In June 2022, a Patent Cooperation Treaty (PCT) application covering Virus Specific T-Cells and Methods of Treating and Preventing Viral Infections was published. This application entered the National Stage in the US, Australia, Canada, Europe, Hong Kong, and Japan.

• Publication Number WO 2022/125746
  

In February 2023, a PCT application covering Methods for Developing CD3+CD8+ Cells Against Multiple Viral Epitopes for Treatment of Viral Infections Including Variants Evolving to Escape Previous Immunity was published. This application entered the National Stage in the US, Australia, Canada, Europe, Japan, Qatar, Saudi Arabia, and United Arab Emirates.

• Publication Number WO 2023/009770
  

Tevogen Bio also had two provisional patent applications in place as of December 2023 for its approach to leveraging artificial intelligence in expediting target detection to accelerate product development:

• AI Algorithm to Predict Immunologically Active HLA-Peptide Complexes
• AI Algorithms to Predict T Cell Receptor Engagement to Specific HLA+ Peptide Complexes

As of September 2024, applications have also been filed for Antigen-Specific T Cell Receptor Engineered T Cells (TCR-T) And Methods of Treating Cancer as well as Tumor Cell Expression of Viral Antigen by Targeting With Stealth Liposome Or Antibody And Subsequent Elimination With Viral Specific CTLs.

Tevogen’s leadership believes the overall value of the company is connected to both its intellectual property portfolio and the progress of its clinical and preclinical programs. The leadership plans to provide shareholders with an update on the fair market value of these assets as soon as they become available.

About Tevogen Bio

Tevogen is a clinical-stage specialty immunotherapy company harnessing CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, aiming to address the significant unmet needs of large patient populations. Tevogen 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 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 and numerous pending patents, two of which are related to artificial intelligence.

Tevogen is driven by a team of experienced industry leaders and scientists with drug development and global product launch experience. Tevogen’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, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; and Tevogen’s ability to generate revenue in the future. 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 effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; 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; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; 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