SHANGHAI and NEW YORK, Jan. 17,
2019 /PRNewswire/ -- Cellular Biomedicine Group, Inc.
(NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm
engaged in the development of immunotherapies for cancer and stem
cell therapies for degenerative diseases, today announced that its
off-the-shelf allogeneic adipose-derived mesenchymal progenitor
cell (haMPC) AlloJoin® therapy for Knee Osteoarthritis (KOA)
has been approved as the first stem cell KOA drug application in
China for a Phase II clinical
trial. China NMPA (formerly CFDA) clarified Cell Therapy
Regulations in December 2017 (the
"Regulation") whereby all cell therapies are being treated as drug
NDA/IND.
Following a 60-day period of priority review of CBMG's IND
application for AlloJoin® for KOA, CBMG's IND application has
become the first stem cell drug application to be approved by CDE
for a Phase II KOA clinical trial since the Regulation's
release.
"We are pleased with this unprecedented milestone," said Tony
(Bizuo) Liu, CEO of CBMG. "The Phase I trial for our proprietary
AlloJoin® product demonstrated good safety and early efficacy for
the prevention of cartilage deterioration, and this new approval
from the CDE brings us closer to helping address the unmet medical
needs of 57 million KOA patients in China."
About AlloJoin®
CBMG's allogeneic adipose-derived
mesenchymal progenitor cell (haMPC) AlloJoin® product is an
off-the-shelf stem cell therapy developed completely in-house by
CBMG over the past 7 years. The entire process to manufacture
AlloJoin® involves many of CBMG's therapeutic and drug intellectual
properties including certain proprietary trade secrets within a
world-class Chemistry, Manufacturing and Controls (CMC) platform,
which patents include methods for collecting, transporting, storing
and qualitating adipose tissue, separation and purification of
adipose stem (progenitor) cells, large-scale clinical grade cell
production, formulations and preparations.
About Knee Osteoarthritis
According to the Foundation
for National Institutes of Health, there are 27 million Americans
with Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA)
occurs in 13% of persons over 60 years of age.
The International Journal of Rheumatic Diseases, 2011
reports approximately 57 million people in China suffering from KOA. Currently no
treatment exists that can effectively preserve knee joint cartilage
or slow the progression of KOA. Current common drug-based methods
of management, including anti-inflammatory medications (NSAIDs),
only provide relief of symptoms accompanied by the risk of side
effects. The mobility of patients with KOA is compromised, leading
to sedentary lifestyle and increases all causes of mortality,
doubles the risk of cardiovascular diseases, diabetes, and obesity,
and increases the risks of colon cancer, high blood pressure,
osteoporosis, lipid disorders, depression and anxiety. According to
Epidemiology of Rheumatic Disease (Silman AJ, Hochberg MC.
Oxford Univ. Press, 1993:257) 53% of KOA patients will
eventually become disabled.
About Cellular Biomedicine Group
Cellular
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 12
independent cell production lines, are designed and managed
according to both China and U.S.
GMP standards. Our Shanghai facility includes a "Joint
Laboratory of Cell Therapy" with GE Healthcare and a "Joint Cell
Therapy Technology Innovation and Application Center" with Thermo
Fisher Scientific, whose partnerships focus on improving
manufacturing processes for cell therapies. The CBMG pipeline
includes preclinical compounds targeting CD20-, CD22- and B-cell
maturation antigen (BCMA)-specific CAR-T compounds, and T-cell
receptor (TCR) and tumor infiltrating lymphocyte (TIL)
technologies. A Phase IIb trial in China for Rejoin® autologous Human
Adipose-derived Mesenchymal Progenitor Cell (haMPC) for the
treatment of Knee Osteoarthritis (KOA) is ongoing and a Phase II
trial in China for AlloJoin™
(CBMG's "Off-the-Shelf" haMPC) has been approved to be conducted.
CBMG is included in the broad-market Russell 3000® Index and the
small-cap Russell 2000® Index, and the Loncar China BioPharma
index. To learn more about CBMG, please
visit www.cellbiomedgroup.com.
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
regulatory approval of our IND applications, our plan to configure
part of our Shanghai facility with
GE Healthcare's FlexFactory platform, our ability to execute on our
obligations under the terms of our licensing and collaboration
arrangement with Novartis, 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, it 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.
Contacts:
Derrick C.
Li
Head of Strategy and Investor Relations, CBMG
+1 917 717 0994
derrick.li@cellbiomedgroup.com
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SOURCE Cellular Biomedicine Group