Tevogen Bio Confirms Ongoing Efficacy of TVGN 489, Its Investigational Allogeneic Off-the-Shelf Immunotherapy, Against Dominant FLiRT Strains of SARS-CoV-2
Tevogen Bio has announced that its investigational immunotherapy, TVGN 489, remains effective against FLiRT strains of SARS-CoV-2, the dominant COVID-19 variants. TVGN 489, a Cytotoxic CD8+ T lymphocyte treatment, targets multiple conserved peptides across SARS-CoV-2 proteins, maintaining efficacy despite mutations. A phase I trial showed significant clinical improvement in high-risk patients, with virus reduction over 99% within 14 days and no significant adverse events. Tevogen plans further trials to assess TVGN 489's ongoing efficacy.
- TVGN 489 retains activity against the dominant FLiRT strains of SARS-CoV-2.
- 95% of Cytotoxic T lymphocytes in TVGN 489 remain active against FLiRT variants.
- Phase I trials showed over 99% virus reduction in high-risk patients within 14 days.
- No dose-limiting toxicities or significant adverse events observed in trials.
- TVGN 489 targets multiple SARS-CoV-2 proteins, reducing the need for frequent formulation changes.
- Tevogen plans further trials to assess ongoing efficacy of TVGN 489.
- The continued efficacy of TVGN 489 against emerging variants is still under surveillance.
- Further trials are needed to confirm the findings, indicating the treatment is not yet fully validated.
- No mention of immediate plans for commercialization or widespread availability.
Insights
Tevogen Bio's announcement about TVGN 489 retaining activity against the dominant FLiRT strains of SARS-CoV-2 is significant for several reasons. Firstly, the persistence of Cytotoxic T lymphocyte (CTL) activity against evolving COVID-19 variants underscores the therapy's potential durability and adaptability. This resilience is particularly important given the rapid mutation rate of the virus, which has rendered many monoclonal antibody treatments less effective over time.
The statement also highlights the use of the ExacTcell™ platform, which targets multiple peptides from across the viral genome. This broad-spectrum approach reduces the likelihood of treatment failure due to single-point mutations in the virus. Such a strategy could offer a more robust defense than therapies focusing solely on the spike protein.
From a clinical perspective, the lack of dose-limiting toxicities and significant treatment-related adverse events in previous trials is promising. The rapid reduction in viral load noted in these trials is a positive indicator of efficacy, especially for high-risk and Long COVID patients who are often left with limited treatment options. Moving forward, the planned later-stage trials will be important in confirming these results and potentially establishing TVGN 489 as a reliable therapeutic option.
The continued efficacy of TVGN 489 against new variants of SARS-CoV-2 presents a valuable opportunity for Tevogen Bio. Being listed on Nasdaq (TVGN), positive clinical outcomes can drive investor confidence and positively influence the stock price. The company's focus on high-risk and Long COVID patients addresses a significant unmet need in the market, potentially opening up substantial revenue streams if the therapy gains approval.
Additionally, the announcement of planned later-stage trials indicates progress towards regulatory milestones. Successful outcomes in these trials could expedite the pathway to commercialization, further boosting financial prospects. However, investors should also be aware of the inherent risks in biotech investments, particularly the uncertainty surrounding clinical trial results and regulatory approvals.
Despite these risks, the use of a broad-spectrum approach and the demonstrated safety profile of TVGN 489 position Tevogen Bio favorably within the competitive landscape of COVID-19 treatments. The company's ability to maintain efficacy across evolving viral strains may provide a competitive edge, potentially leading to market share gains in the long-term.
From a market perspective, Tevogen Bio's TVGN 489 aligns well with current trends in the biotech sector, particularly the shift towards allogeneic off-the-shelf therapies. Unlike autologous treatments, which require personalization for each patient, allogeneic products can be mass-produced, potentially reducing costs and improving accessibility.
The broad applicability of TVGN 489 across various SARS-CoV-2 variants also enhances its market potential. Given the ongoing threat of COVID-19 and the limited treatment options for Long COVID, a therapy that remains effective against new variants could see widespread adoption.
Moreover, the emphasis on targeting multiple viral peptides rather than just the spike protein is a strategic advantage. This approach can appeal to healthcare providers and payers looking for more resilient and adaptable treatments. As the demand for effective COVID-19 therapies continues, TVGN 489 could capture a significant share of the market if it proves successful in later-stage trials.
WARREN, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, today announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated FLiRT strains of SARS-CoV-2 based on a review of this variant’s protein sequences. Named FLiRT to reflect amino acid changes occurring in the spike protein, these Omicron subvariants are descendent from JN.1, the previously dominant strain in the US.
TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, show that
In January 2023, Tevogen reported positive phase I study results in which high-risk patients with the delta, omicron 1, and omicron 2 variants of COVID-19 received TVGN 489, manufactured for the trial in May of 2021. In addition to no dose-limiting toxicities or significant treatment-related adverse events being observed in the treatment arm, all patients, regardless of variant, experienced prompt clinical improvement and a reduced amount of virus in their nasal swabs (>99 to
“We remain committed to developing therapeutic solutions for patients who are highly vulnerable to developing poor outcomes when infected with SARS-CoV-2,” said Tevogen CEO Dr. Ryan Saadi. “I am also highly optimistic about the potential of TVGN 489 to reduce the mortality and morbidity burden of millions of Long Covid patients, where little progress has been made in developing treatments for this condition despite significant government funding.”
TVGN 489 is manufactured using the ExacTcell™ platform in which numerous peptides from across a viral genome are selected as targets for the CTLs, mitigating reductions in cytotoxicity from the loss of one target from mutation. In the case of SARS-CoV-2, the entire COVID-19 genome as opposed to just the Spike protein is targeted. The preservation of T-cell targets across nearly five years of viral evolution avoids the need to make frequent changes to the formulation of TVGN 489 and stands in contrast to the loss of monoclonal antibody targets, which has happened far more rapidly in a number of cases.
About Tevogen Bio
Tevogen 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 three granted patents and twelve pending patents, two of which are related to artificial intelligence.
Tevogen is driven by a team of highly experienced industry leaders and distinguished 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: 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; the healthcare and biopharmaceutical industries; 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: uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks related to the ability to develop, license or acquire new therapeutics; 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 related to the Business Combination; 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; 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; 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; 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 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 TVGN 489?
How effective is TVGN 489 against FLiRT strains?
What were the results of the phase I trial for TVGN 489?
What is the significance of TVGN 489 targeting multiple SARS-CoV-2 proteins?
What are the next steps for TVGN 489?
