Tevogen Bio Provides Additional Guidance on Introduction of T Cell Therapy for Oncology and Specialty Care Therapeutic Areas

Rhea-AI Summary

Tevogen Bio (Nasdaq: TVGN) has provided additional guidance on TVGN 489, the first clinical product of their ExacTcell™ technology. The therapy is designed to treat SARS-CoV-2 infections in immunocompromised oncology patients and certain PASC patients. The company plans market entry by end of 2026. The pipeline includes treatments for various cancers (TVGN 920 for cervical cancer prevention, TVGN 930 for EBV-associated lymphomas, TVGN 960 for mouth and throat cancer) and multiple sclerosis (TVGN 601). TVGN 489's development was achieved at lower costs compared to industry standards, and positive clinical trial results have been reported.

Positive

• Positive clinical trial results for TVGN 489
• Cost-effective development achieved below industry norms
• Clear market entry timeline set for end of 2026
• Diverse pipeline covering multiple therapeutic areas

Negative

• None.

WARREN, N.J., Oct. 25, 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, today provided additional guidance on the first clinical product of the company’s proprietary ExacTcell™ technology, TVGN 489, designed to treat SARS-CoV-2 infections in immunocompromised oncology patients, and a subgroup of patients with post-acute sequelae of SARS-CoV-2 (PASC).

Tevogen Bio’s recently shared forecast reflects its business plan of market entry by the end of 2026.

“The rapid and cost-effective development of TVGN 489, achieved at a fraction of industry norms, strengthens my confidence in Tevogen’s innovative business model,” remarked Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio, Nobel Peace Prize nominee, inventor of ExacTcell. “The positive clinical trial underscores TVGN 489’s potential, and it is my personal commitment that the company will do everything in its power to speed up the development process. I am pleased that the company was able to make progress to bridge any information gap and look forward to sharing other achievements in the coming weeks, particularly on the progress of Tevogen.AI.”

Pipeline

• TVGN 489:
  • Treatment of SARS-CoV-2 infection in patients with B cell hematologic cancer
    [part of Tevogen Bio Oncology forecast]
  • Treatment of SARS-CoV-2 infection in patients with other cancers
    [part of Tevogen Bio Oncology forecast]
  • SARS-CoV-2 infection in patients under treatment for rheumatoid arthritis
  • SARS-CoV-2 infection in patients under treatment for and psoriatic arthritis
  • Treatment of Long COVID [part of Tevogen Bio Specialty Care forecast]
• TVGN 920: Cervical cancer prevention
• TVGN 930: EBV-associated lymphomas
• TVGN 960: Mouth and throat cancer
• TVGN 601: Multiple sclerosis

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

FAQ

When will Tevogen Bio (TVGNW) launch TVGN 489 to market?

According to the company's forecast, Tevogen Bio plans to launch TVGN 489 to market by the end of 2026.

What conditions will TVGN 489 treat?

TVGN 489 is designed to treat SARS-CoV-2 infections in immunocompromised oncology patients and certain patients with post-acute sequelae of SARS-CoV-2 (PASC).

What are the key products in Tevogen Bio's pipeline?

Tevogen's pipeline includes TVGN 489 for COVID-19, TVGN 920 for cervical cancer prevention, TVGN 930 for EBV-associated lymphomas, TVGN 960 for mouth and throat cancer, and TVGN 601 for multiple sclerosis.