Century Therapeutics, Inc. (NASDAQ: IPSC), an innovative
clinical-stage biotechnology company developing induced pluripotent
stem cell (iPSC)-derived cell therapies in immune-oncology, and
FUJIFILM Cellular Dynamics, Inc., a leading global developer and
manufacturer of human iPSCs and iPSC-derived cells, today announce
a new worldwide license agreement and expansion of existing
licenses for the development and commercialization of cell
therapies derived from iPSCs for the treatment of autoimmune and
inflammatory diseases, including type 1 diabetes, multiple
sclerosis, lupus, and rheumatoid arthritis.
There are up to 100 autoimmune conditions which
collectively impact more than 24 million Americans,1 with studies
indicating that both incidence and prevalence of autoimmune disease
are rising for reasons that are poorly understood2. Treatment of
autoimmune disease is currently limited to symptom management, and
includes correcting resulting deficiencies in the body, along with
reducing inflammation and the immune response. iPSCs have the
capability to self-renew and differentiate into key cell types,
providing regenerative and immune-modulating properties as a
treatment modality.
The new licenses expand on the companies’
existing collaboration initiated in 2018 for iPSC-derived cancer
immunotherapeutics.
Under the terms of the agreements, FUJIFILM
Cellular Dynamics will be eligible to receive certain development
and regulatory milestone payments as well as royalties related to
products developed in connection with the companies’
agreements.
“Leveraging our proprietary Allo-Evasion™
technology, we believe we are uniquely positioned to develop
differentiated, effective cell therapies that can be redosed to
potentially deliver effective levels of drug exposure and
immunologic pressure not only for the treatment of cancer, but also
for immunologic diseases with high unmet need. These agreements
enable further evaluation of Century’s iPSC-derived NK, T cell, and
monocyte/macrophage platforms,” said Hy Levitsky, M.D., president
of research and development, Century Therapeutics. “We look forward
to sharing at ASH later this year our first clinical and
translational dataset from the ongoing Phase 1 ELiPSE-1 trial of
CNTY-101, an iPSC-derived CD19-specific CAR-NK cell therapy in
patients with relapsed or refractory B cell lymphomas, supporting
the potential of our platform to overcome the limitations that have
historically prevented the successful application of off-the-shelf
allogeneic NK cell approaches.”
“As a global leader in the field of iPSCs, we
are pleased to expand our partnership with Century as they seek to
develop new and transformative allogeneic cell therapies for the
treatment of immune-mediated diseases,” said Tomoyuki Hasegawa,
president and chief executive officer, FUJIFILM Cellular Dynamics,
Inc. “FUJIFILM Cellular Dynamics supported Century Therapeutics in
the manufacturing of CNTY-101 and we look forward to expanding our
manufacturing partnership to address autoimmune and inflammatory
diseases. We are committed to ensuring that iPSC-derived
therapeutics realize their full potential, and we look forward to
supporting Century Therapeutics’ progress.”
About Century Therapeutics
Century Therapeutics (NASDAQ: IPSC) is
harnessing the power of adult stem cells to develop curative cell
therapy products for cancer and autoimmune and inflammatory
diseases that we believe will allow us to overcome the limitations
of first-generation cell therapies. Our genetically engineered,
iPSC-derived cell product candidates are designed to specifically
target hematologic and solid tumor cancers, with a broadening
application to autoimmune and inflammatory diseases. We are
leveraging our expertise in cellular reprogramming, genetic
engineering, and manufacturing to develop therapies with the
potential to overcome many of the challenges inherent to cell
therapy and provide a significant advantage over existing cell
therapy technologies. We believe our commitment to developing
off-the-shelf cell therapies will expand patient access and provide
an unparalleled opportunity to advance the course of cancer and
autoimmune and inflammatory disease care. For more information on
Century Therapeutics please visit www.centurytx.com.
About FUJIFILM Cellular Dynamics,
Inc.
FUJIFILM Cellular Dynamics, Inc. is a leading
developer and manufacturer of human iPSCs and iPSC-derived cells
utilized in drug discovery, contract development and manufacturing
services for cell therapies. For its partners, FUJIFILM Cellular
Dynamics utilizes its iPSC platform to advance the progress of
therapeutic candidates in the clinic and provides contract
development and manufacturing (CDMO) services. In addition to cell
therapy, FUJIFILM Cellular Dynamics also offers life science
research tools including the company’s inventoried iCell® products,
which are available in almost any cell type and are sourced from
multiple cell lines which can be applied for target identification
as well as toxicity testing. The company also offers custom cell
services and cell banking. FUJIFILM Cellular Dynamics’ goal is to
leverage the vast utility of iPSCs to advance human health and
improve the quality of life for patients around the world. For more
information, please visit: https://www.fujifilmcdi.com/
About FUJIFILM Holdings
Corporation
FUJIFILM Holdings Corporation, Tokyo, leverages
its depth of knowledge and proprietary core technologies to deliver
“Value from Innovation” in our products and services in the
business segments of healthcare, materials, business innovation,
and imaging. Our relentless pursuit of innovation is focused on
providing social value and enhancing the lives of people worldwide.
Fujifilm is committed to responsible environmental stewardship and
good corporate citizenship. For more information about Fujifilm’s
Sustainable Value Plan 2030, click here. For the year ended
March 31, 2023, the company had global revenues of approximately
2.9 trillion yen (21 billion USD at an exchange rate of 134
yen/dollar). For more information, please
visit: www.fujifilmholdings.com.
Century Therapeutics Forward-Looking
Statements
This press release contains forward-looking
statements within the meaning of, and made pursuant to the safe
harbor provisions of, The Private Securities Litigation Reform Act
of 1995. All statements contained in this press release, other than
statements of historical facts or statements that relate to present
facts or current conditions, including but not limited to,
statements regarding our clinical development plans and timelines,
are forward-looking statements. These statements involve known and
unknown risks, uncertainties and other important factors that may
cause our actual results, performance, or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. In some cases, you can identify forward-looking
statements by terms such as “may,” “might,” “will,” “should,”
“expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplate,” “believe,” “estimate,”
“predict,” “forecast,” “potential” or “continue” or the negative of
these terms or other similar expressions. The forward-looking
statements in this press release are only predictions. We have
based these forward-looking statements largely on our current
expectations and projections about future events and financial
trends that we believe may affect our business, financial
condition, and results of operations. These forward-looking
statements speak only as of the date of this press release and are
subject to a number of risks, uncertainties and assumptions, some
of which cannot be predicted or quantified and some of which are
beyond our control, including, among others: our ability to
successfully advance our current and future product candidates
through development activities, preclinical studies, and clinical
trials; our dependence on the success of our lead product
candidate, CNTY-101; uncertainties inherent in the results of
preliminary data, pre-clinical studies and earlier-stage clinical
trials being predictive of the results of early or later-stage
clinical trials; our ability to obtain FDA acceptance for our
future IND submissions and commence clinical trials on expected
timelines, or at all; our reliance on the maintenance of certain
key collaborative relationships for the manufacturing and
development of our product candidates; the timing, scope and
likelihood of regulatory filings and approvals, including final
regulatory approval of our product candidates; the impact of the
COVID-19 pandemic, geopolitical issues, banking instability and
inflation on our business and operations, supply chain and labor
force; the performance of third parties in connection with the
development of our product candidates, including third parties
conducting our clinical trials as well as third-party suppliers and
manufacturers; our ability to successfully commercialize our
product candidates and develop sales and marketing capabilities, if
our product candidates are approved; our ability to recruit and
maintain key members of management and our ability to maintain and
successfully enforce adequate intellectual property protection.
These and other risks and uncertainties are described more fully in
the “Risk Factors” section of our most recent filings with the
Securities and Exchange Commission and available at www.sec.gov.
You should not rely on these forward-looking statements as
predictions of future events. The events and circumstances
reflected in our forward-looking statements may not be achieved or
occur, and actual results could differ materially from those
projected in the forward-looking statements. Moreover, we operate
in a dynamic industry and economy. New risk factors and
uncertainties may emerge from time to time, and it is not possible
for management to predict all risk factors and uncertainties that
we may face. Except as required by applicable law, we do not plan
to publicly update or revise any forward-looking statements
contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise.
Century Contacts:
Investors and Media: Argot Partners –
century@argotpartners.com
Fujifilm Contact:
Christine Jackman, Fujifilm – 914-261-4959 –
christine.jackman@fujifilm.com
1 National Institute of Allergy and Infectious Diseases (NIAID).
Autoimmune Diseases [Website]. National Institutes of Health (NIH):
Bethesda, MA. Available at:
https://www.niaid.nih.gov/diseases-conditions/autoimmune-diseases
[accessed 24 Oct 2023].2 Dinse GE et al. 2020. Arthritis Rheumatol
72(6):1026-1035, PMID: 32266792,
https://doi.org/10.1002/art.41214.
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