Enochian BioSciences Announces the Successful Completion of an FDA Pre-IND for a Potential Cure for HIV: The Second Pre-IND in 1 month
October 18 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
an Investigator 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).
Dr. Serhat Gumrukçu, co-founder and inventor of Enochian
BioSciences, and Director of Seraph Research Institute (SRI),
submitted an investigator-initiated Pre-IND. The request was based
on the results of a 54-year old man living with HIV who had failed
to suppress the virus with antiviral therapy (ART). The patient
subsequently stopped taking ART and received an innovative
treatment developed by SRI.
Enochian BioSciences holds the exclusive license for the
product.
The patient’s HIV infection blood levels were controlled more
effectively for 365 consecutive days, off ART using this new
innovative SRI treatment compared to what had previously been
achieved with ART.
“We are grateful for the FDA’s insightful and useful comments,
which now provide us with a clear path to submit an IND in the
near-term. We are encouraged to know that we are one step closer to
making this treatment available to more people living with HIV,”
said Dr. Mark Dybul, CEO of Enochian BioSciences.
The proprietary therapy includes Natural Killer (NK) and Gamma
Delta T-cells (GDT) collected from another person. During the
entire period, no antiviral drugs were given. It is believed that
the GDT cells, a small subset of immune cells that can be infected
with HIV, could be a key factor in controlling the virus.
Dr. Peter Piot, the former head of UNAIDS and the London School
of Hygiene and Tropical Medicine in London, said, “Although the
results so far are preliminary and in one person, the sooner the
approach can be studied in others, the better. If proven to be
effective, it could offer hope to many who would like to have
alternatives to daily treatment, which can be costly and difficult
to maintain.”
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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