Tevogen Bio Announces IND Submitted to FDA for Clinical Trials of T Cell Treatment for COVID-19
15 October 2020
Tevogen Bio, announced that its Investigational New Drug (IND) application to develop a COVID-19 treatment using proprietary antigen specific T cell technology has been submitted to the US Food and Drug Administration (FDA). Tevogen is partnering with renowned bone marrow transplant expert, Dr. Neal Flomenberg, chair of the Department of Medical Oncology at Thomas Jefferson University, with the intent to evaluate Tevogen's T cell technology to treat hospitalized COVID-19 patients.
This collaboration aims to harness Tevogen's proprietary immunotherapy platform and Dr. Flomenberg's expertise in research and the transplantation of T cells so that both Tevogen and Dr. Flomenberg can conduct clinical trials of T cell treatments for COVID-19. Under normal circumstances, the body generates specific T cells to rid itself of viruses such as COVID-19. In the proposed trials, such T cells will be generated in the laboratory and administered to patients at the sicker end of the COVID-19 spectrum.
For four decades, Dr. Flomenberg has been at the forefront of immunogenetics and immunology. "We are extremely excited to reach this critical stage in advancing Tevogen's T cell therapy for COVID-19 towards clinical trials," Dr. Flomenberg said. "We expect our upcoming Phase I trial to generate data that will hopefully demonstrate the safety of these T cells, the optimal dose of cells we should administer, and how we should best combine them with current COVID-19 standards of care. Though first trials always focus on safety rather than effectiveness, we're hopeful that we'll also see evidence that these cells are effective against this virus."
Yale-trained infectious disease epidemiologist Dr. Ryan Saadi is leading Tevogen's efforts to develop a COVID-19 curative treatment. Dr. Saadi added, "Our mission is not only to develop a T cell therapy cure for COVID-19 and Influenza, but to do so affordably and at scale to meet the extraordinary demand this pandemic requires. I am also hopeful about the potential cancer solutions our oncology portfolio might contribute."
In addition to developing its potential therapies, Tevogen is committed to organizational and manufacturing efficiency. This should allow it to engage in affordable innovation to the benefit of all patients.
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 curative and preventative treatments that are affordable and scalable, in order 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.