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8-K - CURRENT REPORT - Cellular Biomedicine Group, Inc. | cbmg_8k.htm |
Exhibit
99.1
Cellular Biomedicine Group’s AlloJoin®
Therapy for Knee
Osteoarthritis (KOA) Becomes the First Stem Cell Drug
Application Approved in China for Phase II Clinical
Trials
SHANGHAI,
China and NEW YORK, January 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