Enochian BioSciences Announces Its Successful Completion of FDA Pre-IND for a Potential Cure for Hepatitis B Virus Infection
September 27 2021 - 7:00AM
(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.
Contact: ir@enochianbio.com
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