Tevogen Bio Announces Publication of Positive Phase I Clinical Trial Results for TVGN 489 in Blood Advances
Tevogen Bio announced positive Phase I clinical trial results for TVGN 489, an investigational SARS-CoV-2 specific T cell immunotherapy, published in Blood Advances. The study involved 12 high-risk patients receiving TVGN 489 and 18 receiving standard care. Notably, TVGN 489 was well-tolerated, with 88% or greater viral elimination by day 4, and over 99% by day 14. No disease progression or Long COVID was observed in the treatment group. The persistence of donor-derived T-cells was seen through the 6-month follow-up, suggesting potential long-term benefits. Tevogen plans to further test the efficacy and safety of TVGN 489 in later stage trials.
- 88% or greater viral elimination in 92% of patients by day 4.
- >99% viral elimination in all patients by day 14.
- No progression of disease or development of Long COVID in the treatment group.
- Persistence of donor-derived CTLs through the 6-month follow-up period.
- None.
Insights
The publication of positive Phase I clinical trial results for TVGN 489 is a significant milestone for Tevogen Bio. The trial results indicate that the investigational allogeneic SARS-CoV-2-specific CD8+ T lymphocytes (CTLs) therapy was well-tolerated and demonstrated substantial viral elimination in high-risk patients, including those who are immunocompromised or have preexisting cancers.
From a research perspective, the persistence of donor-derived CTLs through the end of the 6-month follow-up period is particularly noteworthy. This suggests a durable response which is critical for long-term disease control. The data also shows no interference with the development of endogenous anti-SARS-CoV-2 responses, suggesting that TVGN 489 could work harmoniously with the patient’s natural immune response.
For retail investors, the positive Phase I results could indicate a promising outlook for Tevogen Bio's future clinical trials and potential FDA approvals. The high rates of viral elimination and lack of progression to Long COVID in the treatment group are strong indicators of the therapy’s efficacy, adding to its potential market value once it progresses through further clinical phases.
Tevogen Bio's announcement of its positive Phase I clinical trial results for TVGN 489 could have a substantial impact on its stock performance. With the therapy showing both safety and efficacy, especially in high-risk, immunocompromised patients, the news is likely to boost investor confidence in the company’s pipeline.
In the short-term, this development could lead to an increase in stock price as investors react to the promising trial results. Long-term implications include potential partnerships or acquisitions, given that successful Phase I results often attract larger pharmaceutical companies looking for innovative therapies to add to their portfolios. Additionally, the potential market for an effective COVID-19 treatment remains large, particularly among vulnerable populations.
Retail investors should also consider the competitive landscape and monitor any upcoming data from Phase II and III trials that could further solidify or challenge the initial positive findings.
The successful Phase I trial results for TVGN 489 are especially significant for patients with preexisting cancers. The fact that this therapy was well-tolerated and showed substantial efficacy in terms of viral elimination without compromising the development of the patient’s natural immune response is a strong positive.
From an oncological perspective, the persistence of donor-derived CTLs is a groundbreaking finding. This could imply not only immediate benefits in controlling the SARS-CoV-2 virus but also potential long-term disease control aspects. This is particularly relevant for cancer patients who are often immunocompromised and at higher risk of severe COVID-19 outcomes.
Understanding the implications of these results could help oncologists consider integrating advanced immunotherapies like TVGN 489 into treatment regimens for their patients, thus widening the scope of effective treatment options available.
WARREN, N.J., June 25, 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, reports publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy by the journal Blood Advances.
Key Observations:
- Interventional arm patients, totaling twelve high-risk individuals,
50% of whom were immunocompromised, and40% of whom were immunocompromised due to preexisting cancers, received a single infusion of one of four escalating doses of TVGN 489, a product containing68.5% 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.
- TVGN 489 was well-tolerated at all four doses tested.
- Nasal swab PCR data showed
88% or greater viral elimination in92% 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.
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.
“We are excited by the outcomes of the phase I trial and are looking forward to both confirming the safety of TVGN 489 and further testing their efficacy in later stage trials in elderly and immune compromised patients with COVID-19 who continue to have higher risk outcomes,” said Dr Dolores Grosso, DNP, Tevogen’s Global Clinical Development Lead.
“The full potential of T cell therapies has yet to be realized. We believe that 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 are the results of Tevogen Bio's Phase I clinical trial for TVGN 489?
What is the significance of TVGN 489 in treating SARS-CoV-2?
How many patients were involved in the TVGN 489 Phase I trial?
Did TVGN 489 show any adverse effects in the Phase I trial?
Will Tevogen Bio continue to test TVGN 489?
