- The primary study endpoints were related to safety. No dose-limiting toxicities or significant adverse events related to TVGN 489, including Cytokine Release Syndrome, were observed in any patient at any dose level.
- Endpoints measuring the reduction of viral load and the presence of cellular and humoral anti-COVID-19 responses after treatment were met.
- Fifty percent (50%) of treatment arm patients were immunocompromised versus six percent (6%) of observational arm patients.
- Treatment arm patients were infected by a variety of SARS-CoV-2 variants ranging from Delta through Omicron BA.5.2.
- Observational arm patients were treated with standard of care including monoclonal antibodies.
- Key observational findings: All treatment arm patients returned to their baseline level of health within 14 days of treatment. No evidence of COVID reinfection or Long COVID was observed in any treated patient at the time of the six (6) month follow up.
WARREN, N.J., Oct. 08, 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 reissues its previously announced topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company’s first clinical product utilizing the internally developed ExacTcell™ technology, for the treatment of acute high-risk SARS-CoV-2 patients. TVGN 489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with precise targets across the SARS-CoV-2 genome, not just the Spike protein. To date, TVGN 489 targets, identified early in the pandemic, persist in the most recent SARS-CoV-2 variants. The open label comparative trial was conducted at Thomas Jefferson University Hospital in Philadelphia to assess the safety and feasibility of TVGN 489 when given at one of four escalating doses. Twelve ambulatory patients with newly diagnosed SARS-CoV-2 infection who were at higher risk for infection-related complications due to advanced age or CDC-defined comorbid conditions such as heart, lung, liver, and kidney disease, hypertension, diabetes, cancer, or obesity were treated on the trial. Eighteen patients, who also met these criteria but did not receive TVGN 489 because of lack of HLA matching, were enrolled on an observational arm in the study and treated with standard of care including monoclonal antibodies.
The treated patients had between 2 to 5 comorbidities each and 6 out of 12 (50%) were immunocompromised due to treatment for cancer or autoimmune disease. Multiple SARS-CoV-2 variants were detected in the group. Safety endpoints included infusion reactions, grade 4 adverse events, GVHD, marrow aplasia, neurotoxicity and CRS.
Table 1. Treatment arm (n=12)
| Safety Criteria as Defined in the Study Protocol | Trial Result |
| Infusion Reactions (≥ Grade 3) | 0/12 |
| Cytokine release syndrome, (Grade ≥ 2) | 0/12 |
| Neurotoxicity (Grade ≥ 2) | 0/12 |
| Graft versus Host Disease | 0/12 |
| Grade ≥4 Adverse Events (Related to the CTL therapy & outside the spectrum of identified COVID related adverse events) | 0/12 |
Safety endpoints were reviewed after each dose level and confirmed by an independent Data and Safety Monitoring Committee at Jefferson and by both internal and external Medical Monitors who provided permission to escalate to the next dose level. Based on the data in Table 1, safety was confirmed with the minimum required number of patients per dosing level. In addition to safety endpoints, endpoints measuring the reduction of viral load and the presence of cellular and humoral anti-SARS-CoV-2 responses after treatment were also met.
Enrollment was completed in nine months, and six-month follow-up for all patients concluded on January 19, 2023. In the treatment arm, no patient experienced progression of their SARS-CoV-2 infection and all patients returned to their baseline level of health within 14 days of treatment. There were no incidences of COVID-19 reinfection or Long COVID observed in any treated patient through the 6-month follow-up period. While patients in the treatment group experienced COVID-19 symptom relief in a rapid, consistent timeframe as self-reported and confirmed by the investigators, patients on the observation arm showed improvement in a less consistent, and in some cases, longer time frame.
The study results were published in Blood Advances, a peer-reviewed journal in August of this year.
“The highly encouraging data of TVGN 489 allows us to turn our attention to the continuing critical unmet need for subsets of the population in the SARS-CoV-2 landscape, such as the elderly, those with Long COVID, and patients who are immunocompromised,” said Dr. Dolores Grosso, DNP, the Principal Investigator of the trial.
Sten Vermund, MD, PhD, Professor of Public Health at Yale University, President of the Global Virus Network, and chair of the Chairperson of Tevogen Bio’s Innovation and Public Health Advisory Board notes that "Immunocompromised individuals, many of whom do not respond to COVID-19 vaccinations, remain at significant risk for severe outcomes from SARS-CoV-2 infections. CTL therapy offers a promising treatment option for this vulnerable group. Preventing prolonged SARS-CoV-2 infections in immunocompromised patients not only improves their health and enables them to resume critical treatments like cancer therapy, but also benefits the wider public. It is within this population that SARS-CoV-2 mutations and resistance to antiviral medications have been observed to develop.”
“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. In 2022, Tevogen Bio was recognized as the highest-valued biotech unicorn, with an independent valuation of $4.2 billion. With the successful completion of this clinical trial and a robust portfolio of assets, I expect the company’s updated valuation, to be reported in the coming days, to show a substantial increase,” said Tevogen founder and CEO Nobel Peace Prize nominee Dr. Ryan Saadi, MD, MPH.
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
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