(NASDAQ: ENOB) --
- Accelerated Pre-Investigational New Drug (Pre-IND) submission
to the US Food and Drug Administration (FDA) for potential cancer
product due to additional promising results from studies in a
commonly used mouse model
- Dr. Anahid Jewett, a leading cancer researcher from the
University of California, Los Angeles (UCLA) presented key results
at the 8th Annual Innate Killer Summit last week (Link to
presentation Excerpt)
- Pre-IND submission expanded to include a phase 1/2a safety and
tolerability clinical study proposal for all solid tumors to be
narrowed to 3-4 most promising indications during a later stage
trial
- IND submission targeted for early 2024
- Cancer platform and product design, for many solid tumors,
could also have application to other pipelines, including
infectious diseases, such as HIV
- Dr Saheed Sadeghi, Clinical Director for the UCLA Santa Monica
Hematology-Oncology Community Practice Group joined the development
team as a consultant to help prepare for clinical activities
- Private Placement of restricted stock has secured approximately
$2.5 million
- Plans in place and eligible to apply for non-dilutive capital
of up to $27 million for IND-enabling studies through clinical
trials
Dr. Anahid Jewett, Professor at the University of California,
Los Angeles (UCLA) and a renowned cancer
researcher in the field of immunotherapy
said, “I have been working in this field for three decades and
designed the mouse model that we have used in my laboratory to
study the Company’s potential cancer therapies. The results are
some of the most impressive I have seen. The fact that we saw very
similar highly statistically significant results across two
independently conducted studies is particularly encouraging,
indicating reproducibility of the findings. I look forward to
continuing our work together towards clinical trials, and
potentially offering hope to many who are suffering with diseases
with few good treatment options.”
“I am delighted to be the Senior Scientific Advisor for Enochian
BioSciences,” said Dr. Richard Whitley, Distinguished Professor of
Pediatrics, Professor of Microbiology, Medicine and Neurosurgery
and Loeb Eminent Scholar Chair in Pediatrics of the University of
Alabama. “I have been very impressed by the Company’s resilience
and the potential human impact of the recent data from the cancer
pipeline with a potential product that could have relevance for
other pipelines in HIV, and perhaps other chronic infectious
diseases. I very much look forward to working with the Company as
they advance the translation of their platform to potential
life-saving interventions for cancer and infectious diseases.”
Dear Shareholders:
On behalf of the Board, Management, and scientific team, I would
like to thank two distinguished leaders in their fields, Professors
Anahid Jewett, Ph.D. and Richard Whitley, MD, for their steadfast
support and belief in the promising future of the Company. In
addition, we offer deep thanks to Dr. Jewett and her colleagues at
UCLA for performing the pivotal proof-of-concept studies that have
allowed us to accelerate our timeline to submit a
Pre-Investigational New Drug (Pre-IND) application to the US
FDA.
I would also like to thank and welcome Dr. Sadeghi to the team.
He brings deep experience and expertise as a consultant as we
prepare for the IND submission, and we hope, clinical trials in
early 2024.
I am pleased to be able to provide shareholders with a summary
of recent advances and what we believe is a promising future for
the Company.
Proof-of-Concept Confirmed for Novel
Cell-Gene-Immunotherapy for Pancreatic Cancer and, Potentially,
Other Solid Tumors
Several key, independent studies performed by Dr. Anahid Jewett
have shown remarkably promising results, demonstrating
proof-of-concept. In two separate studies in humanized mice
implanted with pancreatic cancer, the volume of the tumors was
reduced by an average of 77 to 87 percent following only two
injections of the product. The tumor weight was also highly
statistically significantly reduced. There was also a statistically
significant increase in key immunologic markers in mice potentially
validating the hypothesized mechanism of action via a strong
activation of the immune response by the potential product. Of
note, the mice were evaluated only 3-4 weeks after treatment – it
is possible the effect would have been even greater if the study
were conducted for a longer time. As noted above, Dr. Jewett
presented the key results as part of an invited plenary lecture at
a scientific conference last week ( Link to Press Release and Link
to Presentation Excerpt).
Accelerated Timeline for Pre-IND Submission, Toward
Several Solid Tumors
Because of the strength of the data, we are accelerating the
timeline for a Pre-IND submission to the US FDA, which is
imminent.
Because the mechanism of action could be effective against other
solid tumors, the clinical study design component of the Pre-IND
submission will propose the inclusion of all solid tumors during
the initial safety and tolerability component and based on
preliminary anti-cancer performance, narrowed to a few solid tumor
candidates such as pancreatic, triple-negative breast cancers, head
and neck, and mesothelioma.
Each of those cancers have relatively few treatment options with
poor life-expectancy. For example, the 5-year survival rate for
pancreatic cancer is only 10 percent.
We are targeting submission of the IND application for early
2024 towards potentially starting clinical trials soon after
that.
Basic Platform and Product Design Leveraged for Other
Pipelines Such as Infectious Diseases, Including HIV
The second proof-of-concept study was performed with what we
believe will be the key product design components that we intend to
advance towards clinical studies. Important features of that design
provide the backbone of our overall approach to use cells from
other persons, with or without gene-modification, to renew and
stimulate a stronger immune response than the patient could without
treatment.
We have a similar approach to HIV which could apply to other
chronic infectious disease conditions. Therefore, we can
potentially leverage the design, development, production, and
regulatory processes of the oncology platform for HIV pipelines,
and, perhaps, for additional infectious diseases.
Private Placement and Non-Dilutive
Opportunities
As of March 31, 2023, we raised approximately $2.5 million of
additional funds through a private placement of restricted shares.
The Chair of the Board, René Sindlev, led the round with $1
million, demonstrating his confidence in the Company.
We have identified a total of up to $27 million from three
non-dilutive grant opportunities covering IND-enabling (Pre-IND to
IND) and clinical (post IND) costs. There is, of course, no
guarantee of being awarded any of the grants. But we believe the
strength of the data puts the Company in a strong position.
Conclusion: Turning the Page for a Promising Future
While Working to Maximize Shareholder Value
Despite significant challenges that would have derailed many
companies, our strategic plan to focus on our most promising
platform has allowed us to significantly de-risk our cancer immune
oncology program and be in a strong position now. We have made
substantial scientific and product development advances over the
past 10 months. This was accomplished while substantially reducing
operating costs – including, at my request, a decrease in my
compensation as CEO - towards maximizing shareholder value.
The progress with a platform that has key attributes that could
potentially be leveraged for products to treat solid tumors, HIV
and, perhaps, other infectious diseases is particularly
encouraging. Such an approach could open possibilities to partner,
sell or sub-license individual pipelines towards further potential
maximization of shareholder value. Indeed, as previously announced,
we have already sub-licensed a novel aspect of one of our HIV
pipelines to potentially enhance the effectiveness of a CAR-T
therapy already in clinical trials.
Recent fundraising through a private placement of approximately
$2.5 million and the identification of potential non-dilutive grant
opportunities totaling up to $27 million are encouraging and, yet
again, offer the possibility to maximize shareholder value.
Thank you for taking the time to read this update. We look
forward to your continued support as we work towards life-saving
scientific advances and a promising new future for the Company.
The Hon. Mark Dybul, MDChief Executive Officer, Enochian
BioSciences Inc.
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
Grafico Azioni Enochian Biosciences (NASDAQ:ENOB)
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