WARREN, N.J. - Tevogen Bio (NASDAQ:TVGN), a clinical-stage immunotherapy biotech firm, has announced positive safety outcomes from its proof-of-concept clinical trial for TVGN 489, a T cell therapeutic aimed at treating high-risk SARS-CoV-2 patients. The study, conducted at Thomas Jefferson University Hospital in Philadelphia, showed no significant adverse events or dose-limiting toxicities associated with the treatment.
The trial included 12 ambulatory patients with newly diagnosed SARS-CoV-2 infection who were at higher risk of complications due to comorbid conditions. An additional 18 patients served as an observational arm and received standard care, including monoclonal antibodies. Notably, 50% of the treatment arm participants were immunocompromised, and patients were infected by various SARS-CoV-2 variants, from Delta to Omicron BA.5.2.
Key findings from the trial indicate that all patients in the treatment arm returned to their baseline health level within 14 days post-treatment, with no cases of COVID-19 reinfection or Long COVID observed during the six-month follow-up. This contrasts with the observational arm, where patients showed a less consistent improvement trajectory.
TVGN 489 is a genetically unmodified, off-the-shelf cytotoxic CD8+ T lymphocyte product, targeting multiple SARS-CoV-2 genome components. The trial's safety endpoints, which included infusion reactions and various grade 4 adverse events, were reviewed by an independent Data and Safety Monitoring Committee and external Medical Monitors, allowing for dose escalation.
The results, published in the peer-reviewed journal Blood Advances in August, suggest a potential benefit for immunocompromised individuals and those not responsive to COVID-19 vaccinations. Dr. Sten Vermund, President of the Global Virus Network, highlighted the significance of CTL therapy in preventing prolonged infections and mutations among this vulnerable population.
Tevogen Bio, valued at $4.2 billion in 2022, anticipates an increase in valuation following the successful trial. The company's intellectual property is wholly owned and includes three granted patents with additional pending applications.
This news is based on a press release statement from Tevogen Bio Inc. The company's forward-looking statements involve risks and uncertainties, and actual results may differ materially from those projected. The company has not provided any guidance on when or if TVGN 489 will be commercially available.
In other recent news, Tevogen Bio Holdings Inc. has made significant strides in securing its financial position. The biotechnology firm has raised $6 million through a preferred stock sale, with the investor associated with an existing shareholder purchasing 600 shares of Series C Preferred Stock. This strategic move allows Tevogen to raise capital from an existing stakeholder, potentially fueling further growth and development in its biotechnology ventures. Additionally, Tevogen has secured a $36 million unsecured line of credit from The Patel Family, LLP, and a potential private equity placement (PIPE) arrangement. In terms of product development, Tevogen has demonstrated efficacy against new SARS-CoV-2 variants with its COVID-19 therapy, TVGN 489. On the personnel front, the company announced the appointment of William Keane as Vice President of Strategic Initiatives and the resignation of director Suren Ajjarapu. These are the recent developments in the company's operations.
InvestingPro Insights
While Tevogen Bio's clinical trial results for TVGN 489 show promise, the company's financial health presents a more complex picture. According to InvestingPro data, Tevogen Bio's market capitalization stands at $54.52 million, significantly lower than its 2022 valuation of $4.2 billion mentioned in the article. This stark contrast highlights the volatility in the biotech sector and the impact of clinical trial outcomes on company valuations.
InvestingPro Tips reveal that Tevogen Bio is "quickly burning through cash" and "not profitable over the last twelve months." These factors are particularly relevant for a clinical-stage biotech company, as they indicate the financial challenges faced during the drug development process. The company's operating income for the last twelve months was -$42.45 million, underscoring the substantial costs associated with running clinical trials and developing novel therapies.
Additionally, the stock's performance has been concerning, with InvestingPro data showing a year-to-date price total return of -97.13%. This significant decline aligns with the InvestingPro Tip that the "stock has fared poorly over the last month" and has "fallen significantly over the last year."
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Tevogen Bio, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.