Tevogen Bio, a clinical stage biotechnology company, announced the forthcoming clinical trial of TVGN-489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTL) therapy for COVID-19. The study, expected to begin enrolling patients next week, is designed to evaluate the safety and optimum dosage of TVGN-489 for the treatment of high-risk COVID-19 patients, with Thomas Jefferson University in Philadelphia serving as the clinical trial site.
Dr. Dolores Grosso, the recipient of this year’s award in Clinical Research from the Sidney Kimmel Cancer Center – Jefferson Health, is the Principal Investigator of the TVGN-489 trial. “This trial will evaluate whether this therapy is safe and effective in eliminating the virus in infected high-risk patients,” Grosso said. “We are optimistic that, because TVGN-489 is designed to attack a variety of targets across the SARS-CoV-2 genome, the therapy will be effective against rapidly emerging variants, such as the Delta strain,” Grosso added.
Tevogen’s immunologic treatment is designed to protect COVID-19 patients who are at higher risk of vaccine breakthrough infection and hospitalization due to their age or other underlying health conditions. The study, which administers a single infusion of TVGN-489, will measure changes in the viral load and monitor for any associated symptoms over time as the CTLs mediate their functions in the body. Assessment of the patients’ long-term immune response is an important secondary endpoint. The outcome of the patients receiving TVGN-489 (ARM A) will be compared to matched patients treated with the current standard of care (ARM B).
Tevogen CEO Ryan Saadi, M.D., M.P.H., is leading Tevogen’s efforts. “We are very excited to announce the start of this trial. We believe this work will harness Jefferson University’s unparalleled expertise and research prowess to investigate TVGN-489 as a vital tool in the fight against COVID-19,” Saadi said.
TVGN-489 is highly purified SARS-CoV-2 specific cytotoxic CD8+ T lymphocytes programmed to detect targets spread across the entire viral genome. These targeted CTLs are expected to recognize and kill off virus infected cells, allowing the body to replace them with healthy uninfected cells. TVGN-489 has demonstrated strong antiviral activity against SARS-CoV-2 in preclinical studies.
Dr. Neal Flomenberg, Professor and Chair of the Department of Medical Oncology at Thomas Jefferson University, has spearheaded the research efforts behind the development of TVGN-489 as the Chairman of Tevogen’s Scientific Advisory Board. “CTLs are the tools normally used by our bodies to eliminate viral infections. Current COVID-19 treatments attempt to slow the virus until our own CTLs can develop in adequate numbers to eliminate the infection,” Flomenberg said. “In contrast, TVGN-489 provides substantial numbers of highly enriched, highly potent SARS-CoV-2 specific CTLs directly to the patients. It is because we are using nature’s own tools that we are optimistic that this approach will prove both safe and effective,” he added.
About Tevogen Bio
Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully 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 affordable 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 breakthrough technology overcomes traditional barriers to the broad application of targeted T cell therapies through revolutionary advances in speed to patient and product purity. Tevogen’s focus on organizational and manufacturing efficiency is core to its highly successful biopharma business model and goal 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.