Company encouraged by clear path following review of FDA’s CBER written comments
ShutterstockLOS ANGELES, Sept. 27, 2021 — Enochian BioSciences, Inc., a company focused on gene-modified cellular and immune therapies in infectious diseases and cancer, today announced the completion of a Pre-Investigational New Drug (IND) process following receipt of written comments from the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT).
Globally, there are approximately 350 million people living with chronic liver disease due to HBV, and nearly 1 million people die each year from chronic hepatitis B.
ENOB-HB-01 is a novel approach to potentially eliminate HBV-infected liver cells with an innovative “Hijack RNA” strategy that co-opts the virus’ machinery to induce the death of infected cells rather than reproducing and causing more infection and liver disease. Promising results from animal studies have been presented at scientific meetings (Hep Dart 2019 Presentation and ASGCT 2020 Presentation) by Enochian BioSciences Inventor and Co-Founder, Dr. Serhat Gumrukçu.
“We considered the written response to be very useful and important, providing a clear path to pursuing what we hope will be a successful IND application in the medium-term,” said Dr. Mark Dybul, CEO of Enochian BioSciences. “I want to thank the experts from FDA CBER OTAT for their detailed and helpful insights. We are particularly encouraged because Hijack RNA is a platform that we are developing for other infectious diseases. For example, an inhaled product to potentially treat or prevent any variant of SARS-CoV, including the cause of COVID-19, and any variant of influenza as well as a potential treatment or cure of HIV. The information provided in the FDA’s written comments also help us to accelerate the development of those potential products.”
Dr. Carol Brosgart, member of Enochian’s Board of Directors, Clinical Professor, UCSF, and former Vice President of Clinical Research at Gilead Sciences responsible for HBV and HIV drug development, said, “I have been involved in many efforts to control or cure HBV, but the Hijack RNA approach is the most innovative, with the greatest potential to cure, rather than only control HBV infection that I know of. I have also been involved with many Pre-INDs with the FDA, and I consider their comments remarkably useful to accelerate our product development. In my view, this was a very successful Pre-IND.”
“I have been on the ground floor of several new Biotech companies. Enochian BioSciences is entering a new phase. Based on my experience with the burden of global Hepatitis, I am very enthusiastic about the future and the potential application of our HBV product worldwide,” said Gregg Alton, Enochian Board member and former interim CEO and Chief Patient Officer of Gilead Sciences.
About Enochian BioSciences, Inc.
Enochian BioSciences, Inc. is a biopharmaceutical company focused on developing innovative platforms for gene-modified cellular and immune therapies to potentially cure and treat deadly diseases. The company’s gene-modified cell and immune therapy platforms can potentially be applied to multiple indications, including HIV/AIDS, Hepatitis B, all Corona and Influenza viruses, and Oncology. For more information, please visit Enochianbio.com
Source : Enochian BioSciences, Inc.
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