Tevogen Bio Takes Lead in Developing Cell Therapies Designed to Eradicate Post Procedure Human Papilloma Virus in Women with Precancerous Cervical Lesions

Rhea-AI Summary

Tevogen Bio (Nasdaq: TVGN) is developing TVGN 920, a T cell therapy aimed at treating HPV in women with precancerous cervical lesions. This innovative treatment utilizes Tevogen's proprietary ExacTcell™ technology, employing genetically unmodified, allogeneic cytotoxic CD8+ CTLs targeting the HPV genome. The therapy's dual objectives are to prevent recurrent lesions that could lead to cervical cancer and eradicate HPV infection to halt virus transmission.

Key points:

• Approximately 1 in 3 women remain HPV positive after cervical procedures for precancerous lesions
• HPV is the primary risk factor for high-grade cervical lesion recurrence
• Tevogen aims to address this significant public health concern
• Success could pave the way for treatments of other virus-associated cancers

Positive

• Development of TVGN 920, a potential treatment for persistent HPV in women with precancerous cervical lesions
• Utilization of proprietary ExacTcell™ technology for T cell therapy manufacturing
• Potential to prevent recurrent cervical lesions and eradicate HPV infection
• Possible application of the technology to other virus-associated cancers

Negative

• TVGN 920 is still in early development stages, requiring safety and feasibility studies
• No data on efficacy or success rates of the treatment provided
• Potential challenges in addressing a widespread public health issue like HPV

Insights

Medical Research Analyst

Tevogen Bio's focus on developing TVGN 920, a T cell therapy targeting HPV in women with precancerous cervical lesions, represents a significant advancement in addressing a critical public health issue. The potential to eradicate persistent HPV infections post-procedure could have far-reaching implications:

• Reduce recurrence of high-grade cervical lesions
• Lower the risk of cervical cancer development
• Interrupt the cycle of HPV transmission

The use of Tevogen's proprietary ExacTcell™ technology to create genetically unmodified, allogeneic cytotoxic CD8+ CTLs is particularly noteworthy. This approach could offer a more accessible and potentially safer alternative to current treatments. If successful, TVGN 920 could set a precedent for treating other virus-associated cancers, expanding the scope of T cell therapies beyond their current applications.

However, it's important to note that this therapy is still in the early stages of development. Safety and feasibility studies will be important in determining its viability and potential impact on patient outcomes. Investors should monitor the progress of these studies closely, as positive results could significantly boost Tevogen's market position in the rapidly growing field of immunotherapy.

Financial Analyst

From a financial perspective, Tevogen Bio's focus on HPV-related therapies positions the company in a potentially lucrative market:

• The global HPV therapeutics market is projected to reach $4.5 billion by 2027, with a CAGR of 8.5%.
• Successful development of TVGN 920 could capture a significant portion of this market, particularly given the high recurrence rates of HPV after current treatments.
• The company's broader pipeline targeting common cancers and viral infections expands its potential revenue streams and diversifies risk.

However, investors should consider the following factors:

• As a clinical-stage biotech, Tevogen likely has high R&D expenses and no significant revenue yet.
• The path to market for new therapies is long and costly, with no guarantee of FDA approval.
• Competition in the immunotherapy space is intense, with many well-funded players.

The company's recent Nasdaq listing (TVGN) provides improved access to capital, which is important for funding ongoing research and potential commercialization. Investors should closely monitor clinical trial progress, cash burn rate and any strategic partnerships or licensing deals that could accelerate development or provide additional funding.

• Approximately one in three women remain HPV positive after cervical procedures for precancerous lesions.
• Tens of thousands of women in the US each year are diagnosed with high-grade cervical precancerous lesions.
• These high-grade cervical lesions can reoccur, requiring more treatment, and potentially lead to cervical cancer.
• Nearly all cervical cancer and high-grade cervical lesions are associated with HPV which promotes cancer formation.
• The primary risk factor for the recurrence of high-grade cervical lesions is the continued presence of HPV after procedure.
• HPV is the most common sexually transmitted disease in the world and represents a significant public health burden as persistent infections can lead to cancer in the cervix as well as other areas of the body such as the mouth and throat.

WARREN, N.J., Oct. 15, 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, elaborates on developing TVGN 920, a T cell therapy for the treatment of HPV in women with precancerous cervical lesions.

The investigational product, TVGN 920, will be manufactured utilizing Tevogen’s proprietary ExacTcell™ technology, in which genetically unmodified, allogeneic cytotoxic CD8+ CTLs with precise targets across the HPV genome, will be tested in safety and feasibility studies. Tevogen aims to evaluate the potential of TVGN 920 in treating HPV, a known trigger of cervical cancer, which often persists in women following treatment for high-grade cervical lesions. The goal is to prevent recurrent lesions that could eventually lead to cervical cancer and eradicate HPV infection to prevent transmission of the virus.

“Ability to eradicate HPV in women should offer the dual benefit of preventing recurrent cervical pathology and potentially cervical cancer, as well as interrupting the cycle of HPV transmission, a critical public health concern,” said Dr. Dolores Grosso, DNP, the Clinical Development Lead at Tevogen.

“Several cancers are triggered by viral infections. We hope that success in our efforts will open the door to new treatments for other virus-associated cancers,” commented Dr. Neal Flomenberg, MD, Tevogen’s Chief Scientific Officer.

“Tevogen’s goal is to provide access to the vast and unprecedented potential of personalized immunotherapies for large patient populations impacted by common cancers and viral infections. This is reflected by Tevogen’s research pipeline which includes treatment for HPV and other serious viral infections and cancers using our precision T cell platform,” said Tevogen founder and CEO Dr. Ryan Saadi, MD, MPH, 2023 Nobel Peace Prize nominee.

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

What is Tevogen Bio developing for HPV treatment?

Tevogen Bio (TVGNW) is developing TVGN 920, a T cell therapy designed to treat HPV in women with precancerous cervical lesions using their proprietary ExacTcell™ technology.

How does TVGN 920 aim to address HPV-related issues?

TVGN 920 aims to prevent recurrent cervical lesions that could lead to cervical cancer and eradicate HPV infection to prevent transmission of the virus.

What technology does Tevogen Bio use for TVGN 920?

Tevogen Bio uses its proprietary ExacTcell™ technology to manufacture TVGN 920, which employs genetically unmodified, allogeneic cytotoxic CD8+ CTLs targeting the HPV genome.

What percentage of women remain HPV positive after cervical procedures?

According to the press release, approximately one in three women remain HPV positive after cervical procedures for precancerous lesions.