Tevogen Bio today announced it has completed dosing of the first cohort of patients (n=3) in the proof of concept clinical trial of TVGN-489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTL) immunotherapy for treatment of COVID-19 in high-risk patients.
This single center, open-label clinical trial, conducted at Thomas Jefferson University in Philadelphia, is designed to study the safety, optimal dosage and efficacy of TVGN-489 when given to adult patients (age ≥ 18 years) with a SARS-CoV-2 infection. The trial is enrolling participants at high risk of severe COVID-19 progression due to advanced age or other underlying health conditions. The outcomes of participants receiving the investigational therapy (Arm A) are being compared to patients receiving standard of care (Arm B).
Each of the three patients in the first cohort received a single infusion of TVGN-489 at the lowest dosing level, with no dose limiting toxicities or treatment-related adverse events observed to date. The patients were monitored in the hospital for 4 days before being discharged and were monitored daily at home for an additional 10 days post-discharge. The second cohort of patients in the trial will receive a higher dose level of TVGN-489 via infusion and will follow the same monitoring procedures. The study consists of up to 4 dose levels.
“The dosing and discharge of our first cohort is an exciting milestone for our study and we look to continue to evaluate the safety and efficacy profile of TVGN-489 throughout the remainder of the trial and beyond,” said the Principal Investigator of the trial, Dr. Dolores Grosso, who is the recipient of this year’s award in Clinical Research from the Sidney Kimmel Cancer Center – Jefferson Health. Grosso added, “Genomic sequencing confirmed all patients in the first cohort were infected with Delta lineage B.1.617.2.”
Tevogen CEO Ryan Saadi, M.D., M.P.H., said “Preclinical data of TVGN-489 exhibited strong antiviral activity against SARS-CoV-2, and we are hopeful that the proof of concept study will demonstrate the viability of our investigational T cell therapy to address the significant unmet need in treating COVID-19 patients who are at-risk for more severe outcomes.”
TVGN-489 is a product comprised of highly purified SARS-CoV-2 specific cytotoxic CD8+ T lymphocytes (CTLs) designed to detect targets spread across the entire viral genome. These targeted CTLs are designed to recognize and kill virally infected cells, hopefully allowing the body to replace them with healthy, uninfected cells.
About Tevogen Bio
Tevogen Bio is driven by a team of distinguished scientists and experienced biopharmaceutical leaders who have developed and commercialized multiple franchises. In collaboration with key strategic partners, the company moved its lead product from discovery to clinical phase within 12 months of inception, shaving years off the industry’s standard for drug development timelines.
Tevogen leadership believes that accessible personalized immunotherapies are the next frontier of medicine and disruptive business models are required to sustain medical innovation in the post-pandemic world. The company’s proprietary technology overcomes traditional barriers to the broad application of targeted T cell therapies through advances in speed to patient and product purity. Tevogen’s focus on organizational and manufacturing efficiency is core to its biopharma business model and the company’s goal is to make personalized immunotherapies accessible to the masses for the first time. Tevogen Bio’s research pipeline includes targeted CD8+ T Lymphocyte therapeutics for the treatment of common cancers (NSCLC, Cervical Cancer) and difficult to eradicate serious viral infections (Hepatitis B).
Forward Looking Statements
This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc.’s (the “Company”) development and patient access of its innovations in infectious diseases and oncology. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to a number of factors which involve known and unknown risks, delays, uncertainties and other factors not under the company’s control which may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations implied by these forward-looking statements. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, sales, pricing and actions by the FDA/EMA. The Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and make no representations or warranties in connection herewith or with respect to any omissions herefrom.