Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (CBMG or the
Company), a leading clinical-stage biopharmaceutical firm engaged
in the development of immunotherapies for cancer, has announced its
plan to configure part of its facility in Shanghai with GE
Healthcare’s FlexFactory™ platform, which is expected to be
designed to speed up manufacturing timelines for its cell therapy
clinical trials and commercial launch.
There are more than 900 regenerative medicine
trials underway globally, including trials in cell and gene
therapy, a 19 percent increase since 2016.1 Despite the increased
number of precision medicine trials, gaps exist in how to
manufacture these precise therapies to meet demand. Scalable
integrated solutions to support the transition from clinical trials
to commercialization have been limited. Many of the multiple cell
therapy manufacturing process steps2 remain largely unintegrated
and manual, with open transfers between steps increasing
contamination risk. To address these challenges and allow for
reproducible manufacturing of cell therapies, GE Healthcare has
developed FlexFactory for cell therapy, a scalable, semi-automated
end-to-end platform.
From start to finish, the process of getting a
lab ready for optimized industrial-scale manufacturing would
typically take a cell therapy manufacturer over 18 months to
complete. FlexFactory can reduce this time by up to 50 percent,
getting a company ready to manufacture at scale nine months faster,
ultimately accelerating time to market and enabling clinicians to
deliver therapies to patients sooner. Following the execution of
this non-binding letter of intent (LOI), CBMG expects to become the
first company to install GE’s FlexFactory for cell therapy, and
anticipates that the FlexFactory will be operational in the CBMG-GE
Joint Laboratory of Cell Therapy by the end of 2018.
“This is a productivity revolution in the CAR-T space – this new
generation of semi-automated and standardized CAR-T manufacturing
capabilities created by GE Healthcare and CBMG may allow cell
therapy to provide an optimal platform and opportunity for general
oncology patients. This long-term collaboration with GE could help
us utilize digital technology, semi-automation and analytics, in an
effort to reduce overall costs, and deliver treatments to patients
more efficiently,” said Tony (Bizuo) Liu, Chief Executive Officer,
CBMG.
GE Healthcare’s FlexFactory solution would
support CBMG by providing process development and training
services, cell processing equipment, semi-automation capabilities,
and digital connectivity solutions – all of which support current
good manufacturing practices (cGMP)-compliant manufacturing. CBMG
plans to use its FlexFactory to speed up its timelines for
commercializing its CAR T-cell therapies, targeting various blood
and solid tumor cancers.
“With the rate in which cell therapies are
moving through clinical trials, we understand how critical it is
for companies to scale out manufacturing process capabilities,
while still meeting clinical development timelines and remaining
cost effective. We are committed to collaborating with cell therapy
manufacturers on their journey from trials to industrialization, as
they look to ultimately deliver these groundbreaking therapies to
thousands of patients around the world,” said Ger Brophy, General
Manager, Cell Therapy, GE Healthcare Life Sciences.
Through its collaboration with the Centre for
Commercialization of Regenerative Medicine (CCRM), a leader in
developing and commercializing regenerative medicine technologies
and cell and gene therapies, GE Healthcare expects to provide CBMG
with process development services. The combined GE and CCRM process
development team is comprised of 35 scientists and engineers with
expertise in advanced therapeutic cell technologies, helping bridge
the gap between research protocols and industrial manufacturing. GE
and CCRM expects to support CBMG in increasing process efficiency
by establishing a robust process development effort focused on
simplifying, integrating and automating the manufacturing
workflow.
“CCRM and GE Healthcare established the Centre
for Advanced Therapeutic Cell Technologies, or CATCT, to
industrialize cell manufacturing and accelerate the efforts of
companies working with cell and gene therapies. The partnership
between CBMG and GE is an exciting opportunity for the team at CCRM
to demonstrate its process development skills and knowledge in
overcoming cell therapy production challenges. We look forward to
enabling CBMG in its efforts to commercialize its CAR T-cell
therapy to treat patients with various blood and solid tumor
cancers,” said Michael May, President and CEO, CCRM.
About Cellular Biomedicine
GroupCellular Biomedicine Group, Inc. (NASDAQ:CBMG)
develops proprietary cell therapies for the treatment of cancer and
degenerative diseases. We conduct immuno-oncology and stem cell
clinical trials in China using products from our integrated GMP
laboratory. Our GMP facilities in China, consisting of twelve
independent cell production lines, are designed and managed
according to both China and U.S. GMP standards. CBMG recently
commenced two Phase I human clinical trials in China using CAR-T to
treat relapsed/refractory CD19+ B-cell Acute Lymphoblastic Leukemia
(ALL) and Refractory Diffuse Large B-cell Lymphoma (DLBCL) as well
as an ongoing Phase I trial in China for AlloJoin™ (CBMG’s
“Off-the-Shelf” Allogeneic Human Adipose-derived Mesenchymal Stem
Cell) for the treatment of Knee Osteoarthritis (KOA). In 2017 CBMG
was awarded $2.29 million from the California Institute for
Regenerative Medicine (CIRM) to support pre-clinical studies of
AlloJoin™ for Knee Osteoarthritis in the United States. To learn
more about CBMG, please visit www.cellbiomedgroup.com.
About GE HealthcareHarnessing
data and analytics across hardware, software and biotech, GE
Healthcare is the $18 billion healthcare business of GE (NYSE:GE).
As a leading provider of medical imaging equipment, with a track
record of more than 100 years in the industry and more than 50,000
employees across 100 countries, we transform healthcare by
delivering better outcomes for providers and patients. Follow us on
Facebook, LinkedIn, and Twitter or The Pulse
for latest news. Visit the GE Healthcare Life Sciences website for
more information.
About CCRMCCRM, a Canadian not-for-profit
organization funded by the Government of Canada, the Province of
Ontario, and leading academic and industry partners, supports the
development and commercialization of regenerative medicines and
associated enabling technologies, with a specific focus on cell and
gene therapy. A network of researchers, leading companies,
strategic investors and entrepreneurs, CCRM aims to accelerate the
translation of scientific discovery into new companies and
marketable products for patients, with specialized teams, funding,
and infrastructure. CCRM is the commercialization partner of the
Ontario Institute for Regenerative Medicine and the University of
Toronto’s Medicine by Design. CCRM is hosted by the University of
Toronto. Visit us at www.ccrm.ca.
Forward-Looking Statements
Statements in this press release relating to plans, strategies,
trends, specific activities or investments, and other statements
that are not descriptions of historical facts and may be
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995, Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended. Forward-looking
information is inherently subject to risks and uncertainties, and
actual results could differ materially from those currently
anticipated due to a number of factors, which include those
regarding our ability to implement our plans, strategies and
objectives for future operations, including our plan to configure
part of our Shanghai facility with GE Healthcare’s FlexFactory
platform, our ability to execute on proposed new products, services
or development thereof, results of our clinical research and
development, regulatory infrastructure governing cell therapy and
cellular biopharmaceuticals, our ability to enter into agreements
with any necessary manufacturing, marketing and/or distribution
partners for purposes of commercialization, our ability to seek
intellectual property rights for our product candidates,
competition in the industry in which we operate, overall market
conditions, any statements or assumptions underlying any of the
foregoing and other risks detailed from time to time in CBMG’s
reports filed with the Securities and Exchange Commission,
quarterly reports on form 10-Q, current reports on form 8-K and
annual reports on form 10-K. Forward-looking statements may be
identified by terms such as "may," "will," "expects," "plans,"
"intends," "estimates," "potential," or "continue," or similar
terms or the negative of these terms. Although CBMG believes the
expectations reflected in the forward-looking statements are
reasonable, they cannot guarantee that future results, levels of
activity, performance or achievements will be obtained. CBMG does
not have any obligation to update these forward-looking statements
other than as required by law.
Media Contacts:
Cellular Biomedicine Group (CBMG)Sarah KellyDirector of
Corporate CommunicationsPhone: +1 408 973 7884Email:
sarah.kelly@cellbiomedgroup.com
GE Healthcare Life SciencesRachel EidesCommunicationsPhone: +1
281 409 1031Email: rachel.eides@ge.com
GE Healthcare ChinaRene XuCommunicationsPhone: +86
18101877292Email: rene.xu@ge.com
CCRMStacey JohnsonDirector, Communications and MarketingPhone:
416-946-8869 Email: stacey.johnson@ccrm.ca
1 ARM 2018 State of the
Industry: https://alliancerm.org/sites/default/files/ARM_SOTI_2018_FINAL.pdf
2 The typical cell therapy manufacturing workflow includes
controlled product thaw, isolation, activation, expansion, harvest,
final formulation, and cryopreservation.
Photos accompanying this announcement are available at the
following addresses:
http://www.globenewswire.com/NewsRoom/AttachmentNg/dd2ffbd4-ce06-4c99-85e2-d271506c14ad
http://www.globenewswire.com/NewsRoom/AttachmentNg/a6fadd4e-32cc-456c-9deb-7a3864611c79
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