Organovo Partners With IIAM on Multi-Year Clinical Biomaterial Sourcing Agreement
13 November 2018 - 12:05AM
Organovo Holdings, Inc. (NASDAQ:ONVO) (“Organovo”), a biotechnology
company pioneering the development of 3D bioprinted tissues aimed
at treating a range of serious adult and pediatric liver diseases,
today announced that it has entered into a cell and tissue clinical
sourcing agreement with the International Institute for the
Advancement of Medicine (“IIAM”). Under the terms of the
agreement, IIAM will provide Organovo with donated organs that have
not been utilized for transplantation with high potential benefit
for generating the cell-based building blocks for Organovo’s
therapeutic liver tissue development program.
“We continue to lay the groundwork for the potential start of
human clinical trials in calendar 2020, as we develop our
NovoTissues® to address liver disease in adult and pediatric
populations,” said Taylor J. Crouch, CEO, Organovo. “IIAM is
one of the world’s largest providers of organs and tissues
designated for medical research and development. We’re
thrilled to more closely align our groundbreaking work with
IIAM. This partnership, along with our own expertise in
isolating, characterizing and utilizing specialized human liver
cells, will enable us to create implantable 3D bioprinted liver
tissue patches destined for patient treatment. Our clinical
program expects to serve patient populations that are in desperate
need of new treatment options. Where possible, we will also
leverage the distribution capabilities of our Samsara subsidiary to
put these valuable cells and tissues into the hands of other
leading liver researchers.”
Crouch continued, “As we head into calendar 2019, we’re on track
to pursue orphan designation for a second rare disease indication
and to commence Investigational New Drug (“IND”) enabling studies
for treating end stage liver diseases including Alpha-1-antitrypsin
deficiency, ultimately culminating in a targeted IND filing for
calendar 2020.”
“IIAM is excited to collaborate with Organovo and Samsara as
they work toward clinical applications of liver cells as a therapy
for the patient populations affected with inborn metabolic errors,”
said Gina Dunne Smith, executive director, IIAM. “This is yet
another way for donors and their families to save or improve the
lives of others. As we move forward, these are cutting edge
research projects that are exciting for our entire team.”
“MTF Biologics could not be more pleased with our new agreement
to support Organovo and their therapeutic endeavors,” said Joe
Yaccarino, president and CEO, MTF Biologics. “As the parent
company to IIAM, we are pushing to increase opportunities for
biologics and clinical modalities of many tissue forms. This
latest collaboration is directly in line with our mission of saving
and healing lives through honoring donated gifts, serving patients
and advancing science.”
About Organovo Holdings, Inc.Organovo is a
biotech platform company that has developed a leadership position
with its revolutionary ability to 3D bioprint tissues with human
functionality. The Company is pursuing multiple IND-track
programs to develop its NovoTissues® to address a number of serious
unmet medical needs in adult and pediatric populations, initially
focusing on liver disease. Organovo’s first IND-track program
for Alpha-1-antitrypsin deficiency recently received orphan drug
designation from the FDA, and the Company expects to file its first
IND in 2020. In order to support its plan to initiate
multiple IND-track programs, the Company is providing access to its
ExVive™ in vitro tissue disease modeling platform to facilitate
high value drug discovery and development collaborations.
Organovo’s wholly-owned subsidiary, Samsara Sciences, provides the
Company and its clients with high quality human liver and kidney
cells for research applications. Organovo is changing the
shape of life science research and transforming medical care.
Learn more at www.organovo.com.
About IIAM THE INTERNATIONAL INSTITUTE FOR THE
ADVANCEMENT OF MEDICINE (IIAM) is at the forefront of providing
non-transplantable organs to the medical research community for
purposes of combatting and curing disease. IIAM has
unprecedented collaborations in the U.S. to source livers and other
organs for therapeutic applications and pre-clinical investigations
targeting a range of debilitating metabolic disorders. As a
nonprofit with more than 30 years of experience in the field, IIAM
is a known and trusted partner to both organ procurement
organizations and research institutions worldwide. IIAM works
closely with them to honor donor and donor family intentions to the
fullest by anticipating the next frontier of research requiring
human tissue. IIAM leads the way in educating the next
generation of researchers so that every donor’s legacy leaves the
world a healthier place. IIAM is a wholly-owned subsidiary of
MTF Biologics, also known as Musculoskeletal Transplant Foundation,
a non-profit organization based in Edison, NJ and the world’s
largest tissue bank, whose mission is to save and heal lives by
honoring donated gifts, serving patients and advancing science.
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. Forward-looking statements include, but are
not limited to, statements regarding the potential benefits and
therapeutic uses of the Company’s therapeutic liver tissue,
including the benefits of an orphan designation; the Company’s
expectations regarding the FDA regulatory pathway and anticipated
timelines for its regulatory filings; the potential market
opportunity for the Company’s therapeutic tissue candidates; and
customer demand for and acceptance of its disease modeling and
other in vitro tissue platforms. The factors that could cause
the Company's actual future results to differ materially from
current expectations include, but are not limited to, risks and
uncertainties relating to the possibility that the final results of
the Company's preclinical studies may be different from the
Company's studies or interim preclinical data results and may not
support further clinical development of its therapeutic tissues;
the Company may not successfully complete the required preclinical
and clinical trials required to obtain regulatory approval for its
therapeutic tissues on a timely basis or at all; risks that
competitive products may adversely impact the market opportunity
for the Company’s therapeutic tissue candidates; the
Company's ability to develop, market and sell products and services
based on its technology; the expected benefits and efficacy of the
Company's products, services and technology; the Company’s ability
to execute framework agreements involving multi-year commitments
and routine use on a timely basis, or at all; the Company’s ability
to successfully complete studies and provide the technical
information required to support market acceptance of its products,
services and technology, on a timely basis or at all; the Company's
business, research, product development, regulatory approval,
marketing and distribution plans and strategies, including its use
of third party distributors; the Company’s ability to recognize
deferred revenue; and the Company’s ability to meet its fiscal-year
2019 goals and outlook. These 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 May
31, 2018. 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.
For Organovo: |
For IIAM: |
|
|
Steve Kunszabo |
Nicole
Cottrill |
Organovo Holdings,
Inc. |
Finn Partners |
+1 (858) 224-1092 |
+1 (615)
610-0305 |
skunszabo@organovo.com |
nicole.cottrill@dvlseigenthaler.com |
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