Cell Therapy Company Tevogen Bio Holdings Inc. Prepares to Launch Crucial Genetic Predisposition Study in Preparation to Investigate the Potential of TVGN 489 to Address Critical Unmet Need for Long COVID Treatment
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Insights
The development of TVGN 489, a cytotoxic T lymphocyte (CTL) therapy by Tevogen Bio, marks a significant advancement in the treatment of COVID-19, particularly for high-risk patients. The therapy's ability to target multiple protein segments of the SARS-CoV-2 genome could potentially provide a more comprehensive immune response than treatments focusing on a single viral protein. This broad-spectrum approach is noteworthy given the virus's capacity to mutate, as it may maintain efficacy against emerging variants.
The proof of concept clinical trial's results suggesting a favorable tolerance profile is promising. However, it is crucial to scrutinize the trial's scale, the diversity of the patient population and the parameters used to measure 'tolerance.' The long-term effectiveness and potential side effects will be key factors in evaluating the therapy's viability. Moreover, the planned studies to explore the treatment's efficacy for Long COVID symptoms are of particular interest, as this represents an unmet medical need with a growing patient population.
Understanding the correlation between HLA types and Long COVID could lead to personalized medicine approaches, improving treatment efficacy. However, the financial and time investments required for such personalized therapies could be substantial, posing challenges for scalability and accessibility. Investors should monitor the progress of these trials closely, as positive outcomes could lead to significant market opportunities for Tevogen Bio.
The exploration of Human Leukocyte Antigens (HLA) types in the context of Long COVID is a sophisticated and potentially groundbreaking aspect of Tevogen's research. HLAs play a crucial role in the immune system's ability to present viral antigens to T cells and individual variations in HLA can significantly influence susceptibility and immune response to infections.
The endeavor to match CTL products with the most common HLA types associated with Long COVID, should a correlation be established, reflects a precision medicine strategy that could enhance treatment effectiveness. This approach could revolutionize the way Long COVID is treated, but the complexity of HLA interactions and the necessity for individualized therapies present both scientific and logistical challenges. The impact on the broader healthcare system, in terms of required diagnostics and the cost of personalized treatments, should be considered by stakeholders.
Tevogen's focus on Long COVID treatment trials is strategically aligned with an emerging healthcare market. As Long COVID continues to affect a significant portion of the population, the demand for effective treatments is likely to increase. The company's proactive research into HLA types and their association with Long COVID could position it as a leader in this niche market.
However, the market potential for TVGN 489 will depend on several factors, including the prevalence of Long COVID, the competitive landscape and the ability of healthcare systems to adopt new therapies. It is important for investors to consider the regulatory pathway and market adoption rate when evaluating the potential financial impact of Tevogen's CTL therapy. A successful treatment for Long COVID could open up new revenue streams for the company, but the timeline for clinical trials and FDA approval processes must be factored into any financial forecasts.
- Tevogen’s ExacTcell platform was developed to harness the killing ability of naturally occurring cytotoxic T lymphocytes (CTLs), against viral and malignant targets.
- TVGN 489, a CTL therapy produced by the ExactTcell platform, contains CTLs recognizing multiple protein targets across the SARS-CoV-2 genome. These cells were well tolerated in a completed proof of concept clinical trial in high-risk patients with acute COVID-19, with later stage studies planned in this area.
- Tevogen plans to assess whether TVGN 489 cells can rapidly eliminate symptoms of Long Covid. To facilitate the development of a Long Covid treatment trial, Tevogen will launch a preliminary study in Q1 2024 to assess whether the development of Long COVID is associated with a key component of an individual’s immune system known as Human Leukocyte Antigens (HLA).
- TVGN 489 CTLs work in conjunction with HLA molecules to recognize and destroy viral targets. HLA types vary from person to person and are known to influence degrees of risk in other infectious settings. Specific HLA types may be associated with more or less protection against a particular infection.
Prior to launching the Long COVID clinical trial, Tevogen seeks to address whether Long COVID occurs more commonly with certain HLA types and less commonly with others, or whether Long COVID occurs randomly in the population regardless of HLA. This effort will help Tevogen generate CTL products recognizing the HLA types that are most commonly associated with Long Covid, if a relationship between Long Covid and HLA type is identified, with the goal of allowing a Long COVID treatment trial to be designed and completed expeditiously.
“We have spent significant resources and time identifying TVGN 489’s targets from across the entire COVID genome. These have remained remarkably durable over the last 4 and a half years. I am highly optimistic that TVGN 489 will offer a meaningful solution for both acute and Long COVID patients,” said Neal Flomenberg, MD, Tevogen’s Chief Scientific Officer.
“Generating this information will provide important insights into the immunologic factors that contribute to Long COVID development and will greatly facilitate the treatment trial we expect to follow,” added Shannon Rudolph, Clinical Scientist at Tevogen
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 for the treatment of infectious diseases, cancers, and neurological disorders, 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 granted patents and pending patents, two of which are related to artificial intelligence.
Forward-Looking Statements
This press release contains certain statements that are not historical facts and are forward-looking statements within the meaning of the federal securities laws, including without limitation statements regarding the anticipated benefits of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”), the future financial condition and performance of Tevogen Bio, and the product candidates, products, markets, and expected future performance and market opportunities of Tevogen Bio. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “think,” “strategy,” “future,” “opportunity,” “potential,” “plan,” “seeks,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties.
Factors that could cause actual future events to differ materially from the forward-looking statements in this communication include without limitation: (i) the effect of the announcement of the Business Combination on Tevogen Bio’s business relationships, operating results, and business generally; (ii) the outcome of any legal proceedings that may be instituted against Tevogen Bio related to the Merger Agreement or the Business Combination ; (iii) changes in the markets in which Tevogen Bio competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (iv) changes in domestic and global general economic conditions; (v) risk that Tevogen Bio may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; (vi) risk that Tevogen Bio may not be able to develop and maintain effective internal controls; (vii) costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination or to realize estimated pro forma results and underlying assumptions, including with respect to estimated shareholder redemptions; (viii) the failure to recognize the anticipated benefits of the Business Combination and to achieve Tevogen Bio’s commercialization and development plans, and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen Bio to grow and manage growth economically and hire and retain key employees; (ix) the risk that Tevogen Bio 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; (x) the ability to develop, license or acquire new therapeutics; (xi) the risk that Tevogen Bio will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xii) the risk of product liability or regulatory lawsuits or proceedings relating to Tevogen Bio’s business; (xiii) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; (xiv) risks associated with intellectual property protection; (xv) Tevogen Bio’s limited operating history; and (xvi) those factors discussed in Tevogen Bio’s filings with the SEC and that are contained in the Proxy Statement/Prospectus relating to the Business Combination.
The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the Proxy Statement/Prospectus and other documents to be filed by Tevogen Bio from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and while Tevogen Bio may elect to update these forward-looking statements at some point in the future, they assume no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
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Source: Tevogen Bio
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