Organovo On Track to Establish Human 3D Disease Model in Inflammatory Bowel Disease in 2022
November 30 2021 - 8:05AM
Organovo Holdings, Inc. (Nasdaq: ONVO), today provided a business
overview and progress update, and announced it is on track to
establish its first models of inflammatory bowel disease in 2022
using its 3D bioprinting and other 3D tissue technologies.
In September 2020, Organovo began its new
business strategy after the vote of the stockholders brought a new
Board of Directors into control. Since that time, Organovo has
rebuilt the R&D function of the company and begun its pursuit
of novel drug therapies using its 3D bioprinting and other 3D
biology techniques to model human intestinal diseases like
ulcerative colitis and Crohn’s disease. Organovo believes that
using human cells in 3D tissue models of disease offers the
opportunity to understand and treat disease in a superior way to
the use of animal models.
Organovo has successfully hired and built a
strong scientific team that has begun its efforts in short-term
laboratory space. The company will be moving into its long-term new
space next week, with approximately 8,051 sq. ft. of mixed lab and
office plus 2,892 sq. ft. of dedicated office space. The company
will continue growing its research efforts, including continued
growth in its employee headcount.
Organovo plans to pursue novel drug therapies in
inflammatory bowel disease (IBD) discovered in its 3D tissues. The
company believes that this path offers strong promise because of
inherent advantages in using 3D human tissues, which it believes
offer the promise of finding drugs with a higher chance of success
than those discovered using the prevailing paradigm of animal
models. The company will build a pipeline of drug opportunities,
with more than one drug program in IBD, and will be expanding in
2022 into at least one additional tissue area, beyond intestine,
with another drug program. Multiple tissue types are being
evaluated currently to select the best option for our next
tissue.
Organovo is targeting filing multiple
investigative new drug (IND) applications for novel drug therapies
by 2025, with the opportunity to file the first as early as
2024.
The milestones along the path to putting novel
drugs in the clinic include:
- Disease Model
Building – establishing a 3D model for each specific disease
- Target
Validation and Selection – demonstrating that a gene affects the
disease in the company’s 3D model and beginning a program to find a
drug targeting that gene pathway to modulate disease
- Screening and
Lead Compound Selection – conducting screens (for an oral compound,
antibody, or another modality) to find various drug compounds that
affect the target gene in a way that reduces the evidence of
disease in the 3D models, and selecting the drug compound most
promising for clinical studies
- Investigative
New Drug (IND) Enabling Studies – performing the necessary work to
show safety and efficacy sufficient to enter human clinical
trials
- IND filings with
FDA – providing the data package required by FDA to allow the
initiation of Phase 1 clinical studies in humans with the company’s
novel drug candidates
Organovo plans to communicate its achievements
as it approaches and hits its milestones for drug programs, and to
provide information on its progress towards entering the clinic.
The company believes that its results thus far suggest that it is
on track to establish the necessary disease models of inflammatory
bowel disease in 2022.
According to the Biotechnology Innovation
Organization’s 2021 report, only 7.9% of drugs that enter clinical
trials are approved for human use. Organovo believes that it can
achieve a significantly better success rate than that by using its
3D human tissue models of disease. By leveraging the prior
investments in its bioprinting platform and investing in additional
technologies, the company is positioning itself as a leader in the
creation and use of innovative human 3D tissue models for drug
discovery.
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.
“Clinical Development Success Rates and
Contributing Factors 2011–2020”. Feb. 2021. Co-publication by three
organizations: Biotechnology Innovation Organization (BIO),
PharmaIntelligence, and Quantitative Live Sciences (QLS).
ClinicalDevelopmentSuccessRates2011_2020.pdf (bio.org)
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. These forward-looking statements
include, among others, statements regarding the Company’s
expectations for establishing its first models of inflammatory
bowel disease and the timing thereof, beliefs regarding the
potential effectiveness of using human cells in 3D tissue models of
disease and its potential superiority to the use of animal models,
its plans to expand its research team and employee headcount, the
Company’s plans to pursue novel drug therapies in inflammatory
bowel disease discovered in its 3D tissues and the potential
promise thereof with respect to finding drugs with a higher chance
of success, its expected timing for filing IND applications and the
achievement of milestones with respect thereto. Any forward-looking
statements contained herein are based on current expectations, but
are subject to a number of risks and uncertainties, all of which
are difficult to predict and many of which are beyond the Company’s
control and could cause its actual results to differ materially and
adversely from those expressed in its forward-looking statements,
including, but not limited to: risks related to the Company’s
belief that its use of innovative human 3D tissue models provides
superior way to treat disease; risks that the Company may not move
into the new office space or expand its research team or employee
headcount as planned; risks that the Company fails to establish its
first models of inflammatory bowel disease in 2022; risks that the
Company fails to achieve any milestone along its way to obtain IND
applications or to communicate its progress with respect thereto;
and risks related to COVID-19. These risks and uncertainties and
other factors are identified and described in more detail in the
Company’s filings with the SEC, including its Quarterly Report
on Form 10-Q filed with the SEC on November 8, 2021 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
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