Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential Cure for Hepatitis B Virus Infection

Rhea-AI Summary

Enochian BioSciences, Inc. (NASDAQ: ENOB) announced that the FDA has accepted its Pre-IND request for a potential cure for hepatitis B virus (HBV) infection. This progress follows promising data from a proof-of-concept study in chimeric mice. Dr. Mark Dybul and Dr. Carol Brosgart expressed optimism about the novel Hijack RNA mechanism, highlighting its potential against HBV and other viruses, including COVID-19 and HIV. The company aims to develop gene-modified therapies to address serious diseases affecting millions globally.

Positive

• FDA acceptance of Pre-IND request for HBV cure.
• Promising proof-of-concept study results in chimeric mice.
• Potential commercial product development for HBV.
• Novel Hijack RNA technology shows promise against multiple viruses.

Negative

• None.

LOS ANGELES, July 12, 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 that the FDA has accepted a Pre-IND (Investigational New Drug) request for a potential cure of hepatitis B virus (HBV) infection. Written comments are expected this Fall.

The Pre-IND request was made based on promising data from a proof-of-concept study conducted in chimeric mice, considered by some scientific experts to be the ‘gold standard’ animal model to evaluate HBV cure.

Dr. Mark Dybul, a prominent expert in viruses and Executive Vice Chairperson of the Board of Enochian BioSciences, said, “As a long-time researcher, clinician, and leader of large global disease programs, I am very pleased that the FDA accepted our request to provide feedback to our Hepatitis B development program, and welcome the agency’s input. We are encouraged by the novel mechanism of action, called Hijack RNA that shows promise as a potential platform technology for coronaviruses (including the cause of COVID-19), influenza and HBV, and are exploring its use against HIV.”

Dr. Carol Brosgart, Clinical Professor of Medicine, Epidemiology and Biostatistics, UCSF and former Senior Advisor for Science and Policy to the Division of Viral Hepatitis at the Centers for Disease Control and Prevention, said, “The impressive results in the premier animal model gives me great hope that we are on track to develop a commercial product that could potentially cure HBV infection, a disease that causes chronic liver damage in ~350 million people globally and kills nearly 1 million people each year.” Dr. Brosgart also served as former Vice President of Clinical Research at Gilead Sciences, responsible for HIV and HBV Drug Development, and is a Board Director of Enochian BioSciences.

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.

FAQ

What is the significance of Enochian BioSciences' Pre-IND acceptance by the FDA?

The FDA's acceptance allows Enochian BioSciences to receive feedback on their potential HBV cure, moving them closer to clinical development.

What are the expected next steps following the FDA's acceptance of Enochian BioSciences' Pre-IND request?

Written comments from the FDA are expected this Fall, which will guide the company's future development plans.

What technology is Enochian BioSciences using for its HBV cure?

Enochian is utilizing a novel mechanism called Hijack RNA, which shows promise for curing HBV and potentially other viral infections.

How many people are affected by HBV globally?

Approximately 350 million people are chronically infected with HBV, leading to nearly 1 million deaths each year.

What did Dr. Carol Brosgart say about the results of the animal study?

Dr. Brosgart highlighted the impressive results in the animal model, expressing hope for developing a commercial product to cure HBV infection.