Organovo Achieves 3D Tissue Model for Crohn’s Disease
May 17 2022 - 7:05AM
Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional (3D)
biology company focused on delivering scientific and medical
breakthroughs using novel technologies including 3D bioprinting,
today announces that it has successfully advanced its first
inflammatory bowel disease (IBD) model to the next step of target
discovery and validation for Crohn’s disease. Based on
its internal data and scientific results, the company believes that
its first IBD model correctly demonstrates key aspects of Crohn’s
patient biology that differ from a non-diseased state, and can be
used to find and characterize therapeutics.
“A functional Crohn’s disease model represents a
milestone achievement for Organovo and a key next step on our path
to finding novel drugs” said Jeff Miner, Ph.D., Organovo’s Chief
Scientific Officer, adding, “Our models attempt to mimic the
architecture, cell diversity, and function of the human gut in
healthy and disease states.”
More than 1 million people in North America
suffer from Crohn’s and its prevalence is increasing globally.
Because of its progressive nature, more than 70% will require at
least one surgical intervention to relieve symptoms. Current drugs
can slow progression in about 50% of patients, but none are
curative. Defects in the intestinal lining and inflammation can
lead to abdominal pain, severe diarrhea, fatigue, weight loss,
malnutrition, and lower quality of life. Chronic inflammation leads
to ulcers, fistulas and bowel obstructions caused by fibrosis.
Organovo believes that its 3D tissue technologies are well suited
to drug and target discovery in IBD because they contain a
functional intestinal epithelium that is affected by disease and a
stromal layer demonstrating disease-dependent fibrosis, key targets
for therapy.
Organovo previously announced that it had
updated its business model to capitalize on its human 3D tissue
technologies in drug discovery, building disease models to find
effective therapies that are more likely to succeed in the clinic
than drugs discovered using animal models. We have focused on the
creation of three-dimensional intestinal disease models to discover
therapeutic opportunities that leverage the insights possible from
the truer human biology achievable in 3D human disease models.
The drug discovery process using 3D tissues
consists of several stages. Two steps that are uniquely important
in Organovo’s approach to drug discovery are creation of a disease
model followed by target discovery and validation, each of which
represents substantially de-risking a program. The steps involved
in each require groundbreaking science that represents the
application of tools specific to our approach. Organovo has now
achieved the first of these two steps and is embarking on the
second step. For this first step, there was no guarantee a suitable
model could be achieved using 3D tools, and therefore we believe
the achievement of a suitable model represents a strong step
forward and lowering of risk. The next phase will be target
identification and validation, which we intend to complete by the
end of our fiscal year in March 2023. The remaining steps after
validation of a target substantially resemble typical pharma
development steps to advance a drug to Phase 1 clinical trials.
Organovo is on track to have the Crohn’s disease model being
advanced at this time provide one of the validated targets to
result in an investigative new drug (IND) application by 2025 in
alignment with our previously communicated objective to have
multiple INDs by that time.
Upon validation of targets, we believe the
potential of using 3D models in a given application will be
realized and that the use of 3D tissue technologies will be
substantially de-risked. We expect to then begin medicinal
chemistry to identify a small molecule drug candidate or a parallel
process such as antibody development if the target would best be
engaged with a monoclonal antibody or other modality. Medicinal
chemistry, preclinical safety studies, and other common tasks that
follow consist of fairly common practices across pharmaceutical
development, and are not unique to 3D drug discovery, but can
benefit greatly from the additional insights that can be provided
by testing candidates in human tissue 3D models as the candidates
are screened and developed. Since these steps are more typical, the
risk profile is similar to traditional pharmaceutical development
at these stages. However, upon entering the clinic and seeking
evidence of efficacy in humans, we believe that our use of human 3D
disease models to select drug candidates will result in
significantly higher probability of success.
Organovo will seek to develop multiple pipeline
programs and continues to expect to have multiple IND filings by
2025, which will allow us to progress innovative breakthrough drugs
discovered in our 3D tissue systems into clinical trials. The
company is working on additional IBD disease models representing
different aspects of disease, each of which can represent a
significant advancement over previous tools. Organovo will also
seek to leverage validated targets and scientific knowledge from
these disease models into business development deals and
partnerships with pharmaceutical companies.
About Organovo
Organovo is an early-stage biotechnology company
that is developing and utilizing highly customized 3D human tissues
as dynamic models of healthy and diseased human biology for drug
development. The company’s proprietary technology is being used to
build functional 3D human tissues that mimic key aspects of native
human tissue composition, architecture, function and
disease. Organovo’s advances include cell type-specific
compartments, prevalent intercellular tight junctions, and the
formation of microvascular structures. Management believes these
attributes can enable critical complex, multicellular disease
models that can be used to develop clinically effective drugs for
selected therapeutic areas.
Forward Looking Statements
Any statements contained in this press release
that do not describe historical facts constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. Any forward-looking statements
contained herein are based on current expectations, but are subject
to a number of risks and uncertainties. These risks and
uncertainties and other factors are identified and described in
more detail in the Company’s filings with the SEC, including
its Annual Report on Form 10-K filed with
the SEC on June 15, 2021, as such risk factors are
updated in its most recently filed Quarterly Report on Form 10-Q
filed with the SEC on February 14, 2022. You should not place undue
reliance on these forward-looking statements, which speak only as
of the date that they were made. These cautionary statements should
be considered with any written or oral forward-looking statements
that the Company may issue in the future. Except as required by
applicable law, including the securities laws of the United
States, the Company does not intend to update any of the
forward-looking statements to conform these statements to reflect
actual results, later events or circumstances or to reflect the
occurrence of unanticipated events.
Investor Contact
Amato and Partners, LLCInvestor Relations
Counseladmin@amatoandpartners.com
Organovo (NASDAQ:ONVO)
Historical Stock Chart
From Apr 2024 to May 2024
Organovo (NASDAQ:ONVO)
Historical Stock Chart
From May 2023 to May 2024