Tevogen Bio’s TVGN-489, an Allogeneic SARS-CoV-2 Specific Cytotoxic T Cell Therapy, Demonstrates Strong Anti-Viral Activity in Preclinical Study, as Presented by Professor Neal Flomenberg of Thomas Jefferson University

METUCHEN, N.J.--(BUSINESS WIRE)--#biotechnology--Tevogen Bio, a clinical stage biotechnology company, announced that its investigational COVID-19 therapy, TVGN-489, demonstrated strong antiviral activity against SARS-CoV-2 in the preclinical study. The promising preclinical data was presented yesterday by preeminent expert in allogeneic stem cell and T cell therapy, Dr. Neal Flomenberg, Deputy Director of the Sidney Kimmel Cancer Center – Jefferson Health and Professor and Chairman of the Department of Medical Oncology at Thomas Jefferson University at the 104th Annual Meeting of the American Association of Immunologists.

TVGN-489 is a highly enriched product of cytotoxic T cells (CTLs) trained to recognize peptides encoded by SARS-CoV-2 and eliminate viral infected cells. Tevogen’s proprietary technology resulted in at least a 600-fold expansion and enrichment of the COVID-19 reactive cells found in the blood of individuals who had recovered from a COVID-19 infection without any evidence that these cells were demonstrating phenotypic or functional evidence of exhaustion. COVID-19 reactive cells comprised 70% or more of the cells in initial batches of this product. In 4-hour assays, these cells were able to destroy 75-80% of SARS-CoV-2 infected cells at a very low E:T ratio of 3:1, proving much stronger cytolytic activity than previously reported in similar allogeneic cytotoxic T cell therapeutic approaches to treat viral infections. These data suggest the viability of TVGN-489 as a potentially curative treatment for COVID-19. The goal of this investigational product is to provide off-the-shelf, preformed CTLs, initially to high-risk individuals, whose immune system may be slow at mounting their own immune response to the virus or whose response may be compromised due to various underlying conditions.

“What is most encouraging is that Tevogen’s TVGN-489 CTLs have reached levels of purity and effectiveness in killing COVID-19 infected cells not seen in any previously reported literature,” said Ryan Saadi, MD, MPH, Chairman and CEO of Tevogen Bio. “The breakthrough nature of Tevogen’s technology is that we can overcome two main barriers to develop accessible off-the-shelf T cell therapy for large patient populations: purity and quantity. Sufficient cells have already been prepared to support our initial clinical trial which will be conducted at Thomas Jefferson University.”

About These Data:

“TVGN-489 is quite unique in that it is not a “one size fits all” treatment,” said Dr. Neal Flomenberg. He added, “A patient and donor must match for certain cell surface markers known as HLA for the CTLs to be effective and so, to treat the population, a panel of CTLs must be developed. One may consider this as a personalized therapy for the masses. Very important to note is that T cell targets are spread throughout many of the virus’s proteins which makes T-cell therapy much, much less likely to be rendered inactive due to mutation.” Dr. Flomenberg also noted, “While vaccines are critical to prevent COVID-19 infections, treatment strategies are also essential in addition to these preventative approaches. The issues of viral mutation, vaccine distribution and acceptance, as well as uncertainty about the duration of immunity collectively suggest that we need to be focused on treatment as well as prevention.”

TVGN-489 T cell therapy for COVID-19 involves harvesting T lymphocytes from healthy donors who have recovered from COVID-19. A limited number of carefully selected peptides from the entire viral genome are used to serially activate and expand the CD8+ subset which contains the CTLs. The cells undergo an enrichment step which also helps increase their purity. The first efforts focused on HLA-A*02:01, the most common HLA allele in the population overall. Tevogen Bio is investigating similar approaches to generate CTLs to treat other viral diseases, and a platform technology for new viruses which may arise in the future. Tevogen’s research pipeline also includes targeted CTL therapeutics for both virally and non-virally induced cancers using a variety of proprietary approaches.

About Tevogen Bio

Tevogen Bio was formed after decades of research by its contributors to concentrate and leverage their expertise, spanning multiple sectors of the healthcare industry, to help address some of the most common and deadly illnesses known today. The company’s mission is to provide equitable access to curative and preventative advanced life saving medical innovations, to positively impact global public health.

About Dr. Neal Flomenberg

Dr. Neal Flomenberg is the Chairman of the Department of Medical Oncology and Deputy Director of the Sidney Kimmel Cancer Center at Jefferson University in Philadelphia. Dr. Flomenberg launched Jefferson’s Blood and Marrow Transplantation (BMT) Program in 1995. Throughout his four decades of practice, he has maintained a longstanding interest in the immunogenetics and immunology of stem cell transplantation, with the goal of making transplantation safer and more widely available. He is board certified in the fields of internal medicine, hematology, and medical oncology.

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.

Tevogen Bio
Carla Angel
Carla.angel@tevogen.com

Thomas Jefferson University
Edyta Zielinska
edyta.zielinska@jefferson.edu