Enochian BioSciences Announces that its Cancer Platform Remains on Track for Trials in Humans Following FDA Review
08 Junho 2023 - 9:45AM
(NASDAQ: ENOB). Enochian BioSciences Inc. (the Company) announces
that it remains confident in submitting an Investigational New Drug
Application (IND) for its innovative Cancer Platform in early/mid
2024 following review of comments made by the US Food and Drug
Administration on the Company’s Pre-IND submission. If successful,
that would allow clinical trials to begin by the first half of
2024.
The Company’s proprietary, novel technology uses
cell- and gene-therapy to promote a renewed immune response against
solid tumors. The important confirmatory results from two humanized
mouse models using our novel dendritic-cell based therapy,
independently conducted by Dr. Anahid Jewett, a renowned cancer
researcher in the field of immunotherapy from the University of
California, Los Angeles (UCLA), were presented previously at two
scientific conferences* and were the foundation supporting
potential benefit to people and, therefore, of the Pre-IND
submission.
The initial studies have been conducted in a
pancreatic cancer mouse model developed and published by Dr.
Jewett’s laboratory. Pancreatic cancer is diagnosed globally and in
the USA in approximately 495,000 and 64,000 people, respectively,
each year; nearly 466,000 and 51,000, respectively, die. Because of
limited treatment options, life expectancy is very poor—
approximately 10 percent survival at 5 years. Additionally, the
platform technology could be potent against other solid tumors. The
Pre-IND submission included a human study plan covering pancreatic
cancer as well as other cancers that are difficult to treat,
potentially including triple-negative breast cancer, oral cancers,
and mesothelioma.
“In addition to previously reported data, my
laboratory recently reviewed the tumors removed from the humanized
mice,” said Dr. Jewett. “There was a significant infiltration of
key immune cells in mice treated with the cell- and gene-therapy
with very little tumor remaining. The data also indicate that while
we saw, approximately, an 80 to 90 percent reduction in tumor size
and volume across the two studies, a significant amount of what
remained were immune cells – and not cancer cells. These are among
some of the most promising results that we have seen working in
this field. I very much look forward to beginning studies in humans
and, potentially, to provide hope to many people suffering with
intractable and deadly cancers.”
Dr. Mark Dybul, CEO of the Company, said: “We
are grateful to the FDA for the very timely, thorough, and clear
direction that was provided. After a comprehensive review by our
management, scientific, regulatory, and clinical operations teams,
we believe we have a clear path forward to submit an IND in
early/mid 2024 with clinical trials potentially beginning in first
half of 2024.”
* The Innate Killer Summit, March, 2023, San
Diego, CA, (Link to press release) and Cancer Immunology and
Immunotherapy, April of 2023, Vilnius, Lithuania.
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 Inc. undertakes no obligation to revise or update this
shareholder letter to reflect events or circumstances after the
date hereof.
Source: Enochian Biosciences Inc.
Contact: ir@enochianbio.com
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