Tevogen Bio Highlights the Publication of Promising Trial Data as the CEO Expresses Optimism About the Company’s Scientific Breakthrough in Mainstreaming Cell Therapy Through a New Class of Off-the-Shelf T-Cell Therapies, Manufactured and Stored for Immediate Use

Rhea-AI Summary

Tevogen Bio (Nasdaq: TVGN) highlights the publication of its phase I clinical trial data for TVGN 489, an investigational allogeneic SARS-CoV-2 specific CTL immunotherapy, in the journal Blood Advances. Key observations from the trial include:

- Faster symptom improvement and resolution in the treatment group compared to standard care
- Well-tolerated at all four doses tested
- High viral elimination rates (88%+ by day +4, >99% by day +14)
- No disease progression or Long COVID development in the treatment group
- Persistence of donor-derived CTLs through the 6-month follow-up period

The CEO, Ryan Saadi, expressed optimism about the company's ExacTcell™ platform, stating it represents a significant breakthrough in mainstreaming cell therapy through off-the-shelf T cell therapies for various applications.

Positive

• Phase I clinical trial data for TVGN 489 showed promising results
• Faster symptom improvement and resolution in treatment group compared to standard care
• High viral elimination rates (88%+ by day +4, >99% by day +14)
• No disease progression or Long COVID development in treatment group
• Persistence of donor-derived CTLs through 6-month follow-up period
• Potential applications across virology, oncology, and neurology

Negative

• None.

Insights

Medical Research Analyst

The publication of Tevogen Bio's phase I clinical trial data for TVGN 489, an allogeneic SARS-CoV-2 specific T cell therapy, shows promising results. Key findings include:

• Faster symptom improvement and resolution in the treatment group compared to standard care
• Well-tolerated across all tested doses
• High viral elimination rates (>88% by day 4, >99% by day 14)
• No disease progression or Long COVID development in the treatment group
• Persistence of donor-derived CTLs for up to 6 months

These results suggest potential effectiveness in treating SARS-CoV-2 infections, particularly in high-risk and immunocompromised patients. The unexpected long-term persistence of allogeneic T cells warrants further investigation and could have significant implications for sustained therapeutic effects.

Biotech Industry Expert

Tevogen Bio's ExacTcell™ platform represents a potentially disruptive innovation in cell therapy. The ability to create off-the-shelf, genetically unmodified T cell therapies could address key challenges in the field:

• Manufacturing scalability: Potential for mass production and storage
• Immediate availability: Crucial for rapid response to viral outbreaks
• Broad applicability: Potential uses across virology, oncology and neurology

If successful, this approach could significantly reduce costs and improve accessibility of cell therapies. However, investors should note that while phase I results are promising, larger trials are needed to confirm efficacy and safety. The company's ability to advance its pipeline and secure partnerships will be critical for long-term success in this competitive field.

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, today highlights the publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy, published by the journal Blood Advances in August of this year.

Key Observations:

• Interventional arm patients, totaling twelve high-risk individuals, 50% of whom were immunocompromised, and 40% of whom were immunocompromised due to preexisting cancers, received a single infusion of one of four escalating doses of TVGN 489, a product containing 68.5% SARS-CoV-2-specific CD8+ CTLs/total cells.
• Symptom improvement and resolution in treatment arm patients were compared to an observational group of eighteen patients who received standard care, making a total of 30 study participants. Patients in the treatment group had symptom improvement and resolution more consistently, and in many cases, faster, than those in the observation group.
• TVGN 489 was well-tolerated at all four doses tested.
• Nasal swab PCR data showed 88% or greater viral elimination in 92% of patients by day +4 and > 99% viral elimination in all patients by day +14.
• No progression of disease or the development of Long COVID was observed in the treatment group, despite the prevalence of immunocompromised patients.
• TVGN 489 did not interfere with the development of endogenous anti-SARS-CoV-2 humoral or cellular responses.
• T cell receptor beta (TCRβ) analysis comparing TVGN 489 responses derived from the CTL donor versus recipients showed persistence of donor-derived CTLs through the end of the 6-month follow-up period.
  
  

Afshin Beheshti, PhD, University of Pittsburgh Professor at School of Medicine, Director of the Space Biomedicine Program and Associate Director of the McGowan Institute of Regenerative Medicine, highlighted the ongoing threat of new and mutating viruses and the importance of being able to rapidly develop curative and sustained therapies. “T cells target the whole viral genome and thus avoid being rendered rapidly ineffective with mutagenesis at one site such as the Spike protein in SARS-CoV-2. The development of this type of cellular therapy will not only help with future preparedness but may also be crucial in subsets of the population suffering from viruses such as SARS-CoV-2 now. CTLs can directly target viral proteins in patients with weakened immune systems, such as the elderly and immunocompromised, and may also be effective for Long COVID treatment for which there is currently no known treatment at all. Each SARS-CoV-2 infection increases a person’s risk of developing Long COVID, with far-reaching consequences for both the patient and society as a whole.”

An unanticipated finding was the persistence of the TVG-489 CTLs in all patients tested through the end of the 6-month follow-up period. “Due to the high degree of immune mismatch between the treated patients and the CTL donor, we suspected that after an initial reaction against the SARS-CoV-2 virus, the CTLs would have been quickly eliminated by the patients. Persistence of allogeneic T-cells has been associated with disease control in many settings, therefore, the further exploration of the reason for the persistence and the potential implications is important,” said Neal Flomenberg, Tevogen’s Chief Scientific Officer.

“The full potential of T cell therapies has yet to be realized. We believe our allogeneic, precision T cell technology platform, ExacTcell™, represents a significant scientific breakthrough with the potential to mainstream cell therapy through a new class of off-the-shelf T cell therapies, manufactured and stored for immediate use, with diverse applications across virology, oncology, and neurology,” said Ryan Saadi, CEO of Tevogen Bio.

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, nine pending US and twelve ex-US 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: 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; Tevogen’s manufacturing plans; 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,” “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 presentation 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.

These factors 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; 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 associated with intellectual property protection; 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; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; 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; the risk that Tevogen may not be able to develop and maintain effective internal controls; 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; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; Tevogen’s limited operating history; and those factors discussed in Tevogen’s Annual Report on Form 10-K and other 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 were the key findings of Tevogen Bio's phase I clinical trial for TVGN 489?

The key findings included faster symptom improvement in the treatment group, high viral elimination rates (88%+ by day +4, >99% by day +14), no disease progression or Long COVID development, and persistence of donor-derived CTLs through the 6-month follow-up period.

How did TVGN 489 perform in terms of safety during the clinical trial?

TVGN 489 was well-tolerated at all four doses tested during the phase I clinical trial.

What is the potential impact of Tevogen Bio's ExacTcell™ platform according to the CEO?

According to CEO Ryan Saadi, the ExacTcell™ platform represents a significant scientific breakthrough with the potential to mainstream cell therapy through a new class of off-the-shelf T cell therapies for diverse applications across virology, oncology, and neurology.

What unexpected finding was observed in the TVGN 489 clinical trial?

An unexpected finding was the persistence of the TVG-489 CTLs in all patients tested through the end of the 6-month follow-up period, despite the high degree of immune mismatch between treated patients and the CTL donor.