Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential Cure for Hepatitis B Virus Infection
July 12 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 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 StatementsStatements 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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