Enochian BioSciences Announces Its Successful Completion of FDA Pre-IND for a Potential Cure for Hepatitis B Virus Infection
Enochian BioSciences announces completion of its Pre-Investigational New Drug (IND) process, following helpful feedback from the FDA’s CBER. This feedback outlines a clear path towards a successful IND application for the innovative ENOB-HB-01 therapy, which employs a 'Hijack RNA' strategy to eliminate HBV-infected liver cells. With nearly 350 million individuals affected globally by chronic liver disease from HBV, the company aims to develop impactful treatments. The FDA’s insights are also expected to expedite the development of other potential therapeutic products.
- Completion of the Pre-IND process enhances the potential for a successful IND application.
- Positive FDA feedback provides a clear development pathway for ENOB-HB-01.
- ENOB-HB-01 employs an innovative approach to potentially eliminate HBV-infected liver cells.
- FDA insights are expected to accelerate development of additional therapies for other diseases.
- None.
Company encouraged by clear path following review of FDA’s CBER written comments
LOS ANGELES, Sept. 27, 2021 (GLOBE NEWSWIRE) -- (NASDAQ: ENOB) − 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
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties, including but not limited to the success or efficacy of our pipeline. All statements other than historical facts are forward-looking statements, which can be identified by the use of forward-looking terminology such as “believes,” “plans,” “expects,” “aims,” “intends,” “potential,” or similar expressions. Actual events or results may differ materially from those projected in any of such statements due to various uncertainties, including as set forth in Enochian BioSciences’ most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Enochian BioSciences undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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