Enochian BioSciences Announces FDA Acceptance of Pre-IND Request For Potential HIV Cure
June 14 2021 - 7:00AM
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 functional cure
or treatment of HIV. Written comments are expected this Fall.
Dr. Serhat Gumrukçu, co-founder and inventor of
Enochian BioSciences, and Director of Seraph Research Institute
(SRI), submitted the 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. The patient subsequently achieved
viral control for 255 days with an innovative treatment of 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.
The findings were presented during the
Conference of the American Society of Gene and Cell Therapy this
past May. Presentations can be found at
Enochianbio.com/Collaborations
Enochian BioSciences holds the exclusive license
for the proprietary technology.
This innovative cellular therapy could be an
important approach to achieve a “functional cure” of HIV,
potentially allowing persons with the virus to stop antiviral
treatment for extended periods of time. The Pre-IND submission
requested that the novel strategy be extended to persons with HIV
who have achieved suppression of the virus with antiviral
treatment.
Dr. Mark Dybul, a prominent expert in HIV and
Executive Vice Chairperson of the Board of Enochian BioSciences
said: “As an HIV researcher, clinician and past leader of large,
global HIV programs, I am very excited by the FDA’s decision to
provide responses to the Pre-IND submission. Because the promising
early results are only in one person, it is important to study the
approach in a larger population. In addition, because many people
achieve suppression with antiviral treatment, it is key to extend
the evaluation to that specific group. Pre-IND is an important step
to exploring the possibility of testing this novel NK-GDT
treatment.”
Dr. Peter Piot, the former head of UNAIDS and
Director of the London School of Hygiene and Tropical Medicine in
London, said: “It is important to explore any potential for persons
with HIV to safely stop antiviral drugs and control the virus.
Although the results so far are preliminary and in one person, if
the NK-GDT therapy is proven to be effective in others, it could
offer hope to many who experience significant side effects from, or
have grown tired of, daily antiviral medication.”
About Enochian BioSciences,
Inc.Enochian BioSciences, Inc. is a biopharmaceutical
company dedicated to identifying, developing, manufacturing, and
commercializing gene-modified cell therapy. The company’s
gene-modified cell therapy platform can be applied to multiple
indications, including HIV/AIDS and Oncology. For more information,
please visit Enochianbio.com
About Seraph Research Institute
(SRI)Seraph Research Institute is a Los Angeles-based
non-profit research institution, which runs basic science,
translational and clinical research in pursuit of cures and
effective treatments for chronic viral infections, cancers, and
genetic disorders. For more information, please visit
Seraphinstitute.org
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 BioScience’s 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. The findings in this press release are
preliminary and based on one person. There is no assurance the
findings will result in an effective alternative treatment for
HIV. All forward-looking statements are qualified in
their entirety by this cautionary statement, and Enochian
BioScience 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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