Hamner Institutes, Cellular Dynamics: Collaborate to develop in vitro assays using human iPS cell-derived hepatocytes

Contacts:

Joleen Rau
Senior Director, Marketing & Communications
Cellular Dynamics International, Inc.
(608) 310-5142
jrau@cellulardynamics.com

Robert E. Flamm, Ph.D.
Russo Partners LLC
(212) 845-4226
robert.flamm@russopartnersllc.com

Investor Relations
Gitanjali Jain Ogawa
The Trout Group, LLC
(646) 378-2949
gogawa@troutgroup.com

Jake Potter
The Hamner Institute for Health Sciences, MMI Public Relations
(919) 233-6600
jake@mmipublicrelations.com

Susan Berg
Agilent Technologies, Inc.
(408) 553-7093
susan_berg1@agilent.com

RESEARCH TRIANGLE PARK, N.C. and MADISON, Wis., Dec. 9, 2013 (GLOBE
NEWSWIRE) — The Hamner Institutes for Health Sciences today announced
a collaborative agreement with Cellular Dynamics International (CDI) to
develop predictive in vitro screening assays for chemical,
environmental and pharmaceutical toxicology assessments that utilize
CDI’s human induced pluripotent stem (iPS) cell-derived hepatocytes.

Current in vitro models of liver function employ immortalized cell
lines, animal models and primary tissue isolates harvested from human
cadavers. Each of these model systems presents limitations in
functionality, reproducibility, translatability and availability.

Human iPS cell-derived hepatocytes could provide a consistent,
reproducible and limitless source of liver tissue that reflects native
liver function and may offer significant improvement over existing in
vitro models.

CDI will provide iCell(R) Hepatocytes to The Hamner for use in an
on-going program of research, referred to as “Toxicity Testing in the
21st Century: Toxicity Pathways and Network Biology.” This program
employs several prototypical toxicity pathway case studies to develop
human cell-based assays that map and model key cell signaling pathways
in order to evaluate dose response. These assays, once validated with
prototype chemicals, should enable toxicity testing and risk
assessments based solely on in vitro test results, without progressing
to toxicity studies in intact animals.

These in vitro-based toxicity testing schemes will speed testing of
both important compounds in commerce and new compounds coming into use.
More rapid testing will also help assess the backlog of thousands of
chemicals for which there is very limited toxicity test data. As these
test technologies mature, they could also provide a means to speed drug
discovery by providing assessments of safety far earlier in the drug
development process.

The Hamner toxicity pathway research program is a pre-competitive,
multi-organization partnership designed to advance an integrated
systems biology approach to toxicity testing research. Partners
sponsoring the research include Agilent Technologies Inc., Illumina,
Dow Chemical, Dow Corning Corporation, ExxonMobil, Unilever and
CropLife America member companies. The Long-Range Research Initiative
(LRI) of the American Chemistry Council supported earlier stages of
this research. CDI will join this consortium and will collaborate with
Hamner scientists on technical aspects of assay development.

“The Hamner’s multi-stakeholder toxicity testing program needs a
variety of normal cell types for studying chemical toxicity in human
cells. New iPS-cell technologies, spearheaded by CDI, promise to make
many stem cell-derived products available to transform in vitro
testing. We are particularly enthusiastic about the use of iCell
Hepatocytes to create models of liver toxicity and for evaluating
pathways of metabolism,” said Dr. Melvin Andersen, project director at
The Hamner. “More broadly, stem cell products enhance work on the whole
suite of pathways of interest to our diverse partners. As other stem
cell platforms develop, we can connect them sequentially and examine
multi-day treatment for many tissues with realistic exposures. These
iCell Hepatocytes and other emerging stem cell-based products provide
great value for safety assessments for all our partners.”

Chris Parker, chief commercial officer of CDI, said, “We are excited to
be working with The Hamner and this consortium to work toward better
predictivity of human response to chemical compounds. Current models
miss toxicities that might only manifest themselves in a human cell
model, or falsely misidentify toxicities for compounds that would be
safe. Published studies have shown numerous examples of our human iPS
cell-derived iCell products to be more predictive than comparison
current cell models. Through this collaboration we hope to further
improve the safety of chemical compounds as well as the efficiency of
research studies.”

A report of a recent review of The Hamner program “Toxicity Testing in
the 21st Century: Toxicity Pathways and Network Biology” is available
at www.thehamner.org/tt21c and provides a synopsis of the first
prototype pathways serving as examples of this integrated systems
biology approach to toxicity testing.

About The Hamner Institutes for Health Sciences

The Hamner Institutes for Health Sciences is a nonprofit translational
biomedical research institute located on an open, multidisciplinary
campus in North Carolina’s Research Triangle Park. Building upon 35
years of research excellence in toxicology, The Hamner works on drug
and chemical safety in collaboration with academic, corporate, and
government partners. Novel technologies used at The Hamner include
genomic and bioinformatic approaches for improving toxicity testing, in
silico models for predictive toxicology, in vitro models that utilize
human cells or cell lines to evaluate perturbations of cellular
responses, and in vivo models to elucidate genes that play a role in
susceptibility to drug-induced toxicities. For more information, visit
http://www.thehamner.org.

About Cellular Dynamics International, Inc.

Cellular Dynamics International, Inc. (CDI) is a leading developer of
induced pluripotent stem cell technologies for in vitro drug
development, stem cell banking and in vivo cellular therapeutic
research. CDI harnesses its unique manufacturing technology to produce
differentiated tissue cells in industrial quality, quantity and purity
from any individual’s induced pluripotent stem cell line created from a
standard blood draw. CDI was founded in 2004 by Dr. James Thomson, a
pioneer in human pluripotent stem cell research at the University of
Wisconsin-Madison. CDI’s facilities are located in Madison, Wisconsin,
with a second facility in Novato, California. See
www.cellulardynamics.com. Follow us on Twitter @CellDynamics or
www.twitter.com/celldynamics

Forward-looking Statements

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Cellular Dynamics
International, Inc., including statements regarding our products and
iPS-cell technologies, they are forward-looking statements reflecting
the current beliefs and expectations of management made pursuant to the
safe harbor provisions of the Private Securities Litigation Reform Act
of 1995. Words such as “may,” “will,” “believe,” “expect,”
“anticipate,” “estimate,” “intend,” and similar expressions (as well as
other words or expressions referencing future events, conditions or
circumstances) are intended to identify forward-looking statements.
Forward-looking statements in this release involve substantial risks
and uncertainties that could cause our product development efforts,
actual results, performance or achievements to differ materially from
those expressed or implied by the forward-looking statements. Cellular
Dynamics undertakes no obligation to update or revise any
forward-looking statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of the Company in general, see Cellular
Dynamics’ quarterly report on Form 10-Q filed with the Securities and
Exchange Commission on August 29, 2013, and as may be described from
time to time in Cellular Dynamics’ subsequent SEC filings.