Enochian BioSciences Announces Its Successful Completion of FDA INTERACT Meeting for a Potential Cure for HIV
June 08 2020 - 7:30AM
(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 Initial Targeted
Engagement for Regulatory Advice (INTERACT) meeting with the U.S.
Food and Drug Administration (FDA) Center for Biologics Evaluation
and Research (CBER) Office of Tissues and Advanced Therapies
(OTAT). The meeting, which included management and scientists
from Enochian BioSciences together with CBER OTAT staff, focused on
the pathway forward for ENOB-HV-01. ENOB-HV-01 is a novel approach
to autologous stem cell transplantation, with the potential to cure
HIV by increasing engraftment of gene-modified cells that are
resistant to HIV infection. Failure to achieve engraftment
has limited the success of other attempts to cure HIV with
autologous transplantation.
“We considered the meeting to be very
successful, with strong alignment between Enochian’s approach to
developing ENOB-HV-01 and the comments of the FDA reviewers,” said
Dr. Mark Dybul, Executive Vice-Chair of Enochian BioSciences. “I
want to thank the reviewers from FDA CBER OTAT for their time and
helpful insight during our meeting. We look forward to
advancing our thoughtful and deliberate pre-clinical work during
the remainder of this year and into early next, leading to a
pre-IND submission in 2021.”
Dr. W. David Hardy, Chair of Enochian
BioSciences’ Scientific Advisory Board and the former Chief Medical
Officer of Calimmune, said: “The novel approach we are pursuing has
the potential to overcome the challenges of engraftment commonly
encountered by others in the field. While still early, thus
far the data have exceeded my expectations, and I believe the FDA
reviewer feedback was very much aligned with our development
plan. After more than 30 years as an HIV clinician and
researcher, it is a great privilege to be involved with an
enterprise with the potential to cure HIV, offering hope to
millions of people.”
INTERACT is the first available FDA interaction
and is a key step in the process towards a potential
Investigational New Drug (IND) to study First-in-Human products
potentially leading to marketing authorization via Biologics
License Application (BLA). The FDA’s Center for Biologics
Evaluation and Research (CBER) has numerous INTERACT requests and
only grants meetings that are deemed appropriate for this early FDA
engagement.
About Enochian BioSciences,
Inc.Enochian BioSciences is a biopharmaceutical company
dedicated to identifying, developing, manufacturing, and
commercializing gene-modified cell therapy. Our gene-modified cell
therapy platform can be applied to multiple indications, including
HIV/AIDS, HBV, and Oncology.
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’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. All forward-looking statements are qualified in their
entirety by this cautionary statement, and Enochian undertakes no
obligation to revise or update this press release to reflect events
or circumstances after the date hereof.
Investor Contact:
Luisa Puche, CFO
ir@enochianbio.com
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