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EX-99.1 - PRESENTATION, DATED MARCH 16, 2018 - Cellular Biomedicine Group, Inc. | cbmg_ex991.htm |
8-K - CURRENT REPORT - Cellular Biomedicine Group, Inc. | cbmg_8k.htm |
Exhibit
99.2
Cellular Biomedicine Group Announces
Positive 48-Week Clinical Data of AlloJoinTM
Human Adipose-Derived Mesenchymal
Progenitor Cell (haMPC) Knee Osteoarthritis (KOA) China Phase I
Trial
SHANGHAI, China and CUPERTINO, Calif., Mar. 16, 2018 —
Cellular Biomedicine Group Inc. (NASDAQ: CBMG) (“CBMG”
or the “Company”), a clinical-stage biopharmaceutical
firm engaged in the development of immunotherapies for cancer and
stem cell therapies for degenerative diseases, today announces
48-week clinical data from the Phase I clinical trial in China for
its allogeneic adipose-derived mesenchymal progenitor cell
off-the-shelf therapy AlloJoinTM
for Knee Osteoarthritis (KOA). The
data was presented on March 16, 2018 at the B. Riley FBR Inaugural
China Healthcare Investing & Partnering Symposium (CHIPS)
conference in Hangzhou, China, by Dr. ChengXiang (Chase) Dai,
General Manager of the Company’s Stem Cell Business
Unit.
“We are very encouraged by the latest data
from our AlloJoinTM Phase
I trial in China which demonstrates good safety and early
efficacy for the prevention of cartilage deterioration. The
recent regulatory guidelines issued by the CFDA have set
a clearer clinical and commercialization pathway for our
AlloJoinTM platform.
The success of the trial thus far, targeting
an addressable market of 57 million KOA patients in
China, prompted us to realign our resources
to better focus on the China market. We believe
developing our KOA therapies in China is a faster path to market at
a fraction of the cost of conducting US trials,” said Tony
(Bizuo) Liu, CEO for the Company. “In that light, we
are de-prioritizing the U.S. AlloJoinTM operation and
the California Institute of Regenerative Medicine (CIRM)
project has been terminated, effective March 14,
2018. The two AlloJoinTM cell
banks, which we have created in the U.S, will now be stored in
our Maryland facility for future use. We will continue to
advance in China both our stem cell and CAR-T platforms as each
becomes more widely approved.”
AlloJoinTM
Phase I 48-week Data
Analysis
The 48-week analysis of study data of 22 patients demonstrated
AlloJoinTM
off-the-shelf allogeneic stem cell
therapy for KOA to have good safety tolerance and early signs of
efficacy in preventing cartilage deterioration. The total WOMAC
scores (consisting of pain, stiffness and function scores of
joints) as a primary end point showed a significant improvement at
12 weeks post AlloJoinTM
cell therapy and continued improvement
at 48 weeks. The secondary evaluation end point, the data of 3D
spoiled gradient-recalled echo (SPGR) quantitative magnetic
resonance imaging (MRI) for whole knee cartilage volume at 48 weeks
showed an increased tendency when compared with that at baseline 0
weeks, and as compared with normal cartilage deterioration as a
result of aging.
The presentation with detailed data can be viewed on the Company
website under the Investor section.
“The analysis of this early stage clinical study has
indicated a good safety and potential efficacy for an off-the-shelf
allogeneic haMPC therapy, which would allow us to continue to
advance clinical trials to confirm efficacy of such cell therapy in
preventing cartilage deterioration. The Company believes that the
opportunity for patients to prevent further knee cartilage
degeneration and improve the long-term quality of life using stem
cells could be preferable to undergoing drug treatment with adverse
side effects or painful and invasive knee replacement surgery. If
this allogeneic cell therapy, which takes less time and cost to
produce as compared to autologous therapies, would be proved
effective and approved for clinical use, then 57 million
symptomatic KOA patients in China may
have access to a more hopeful therapy, which could stop or delay
cartilage deterioration and also improve joint pain, stiffness and
movement function”, commented Dr.
Chengxiang (Chase) Dai, General Manager, Stem Cell Business Unit of
CBMG.
Common side effects were temporary local reactions including
soreness and swelling at the injection site and negligible systemic
reactions, except one patient that reported transient dizziness
after inter-articular injection of AlloJoinTM.
Two patients who underwent one dose of injections dropped out of
the study as they reported their knee joints were more painful
after injection. To date, no serious adverse events (SAE) related
to AlloJoinTM
therapy have been
reported.
About the AlloJoinTM
Clinical Trial
The Phase I clinical research trial for AlloJoinTM,
registered at ClinicalTrials.gov under the number
NCT02641860,
is conducted in China at Shanghai Renji Hospital, one of the
largest teaching hospitals in China, with Principal
Investigator Chunde Bao, MD, Professor of Medicine, Vice Chairman
of the Chinese
Rheumatology
Association. The single-center study
enrolled 22 patients with knee osteoarthritis (Kellgren-Lawrence
Grading Scale: grade II-III) to participate in a randomized,
double-blind trial with three different cell dose
groups.
The primary endpoints for this trial were safety and knee-related
pain, stiffness and function measured using the Western Ontario and
McMaster Universities (WOMAC) osteoarthritis index questionnaire.
The secondary endpoints were cartilage repair at 12 months by
assessment of changes of the knee joint cartilage’s volume
measured with 3D SPGR quantitative MRI, in addition to VAS, SF-36
and Whole-Organ Magnetic Resonance Imaging Score (WORMS)
scores.
Of the 22 patients enrolled, 20 patients underwent two doses of
intra-articular injections of AlloJoinTM
at 3-week intervals. All 20
of those patients were followed up and evaluated for safety and
efficacy at 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks, and 48
weeks. Nineteen of the 22 patients were evaluated by third-party
quantitative MRI assessment of the whole joint cartilage volume at
baseline and 48 weeks. The Company has completed data management
and statistics analysis via third-party statistics unit, Department
of Health Statistics, Public Health College, Fudan
University.
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 twelve
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, which partnerships focus on improving manufacturing
processes for cell therapies. CBMG currently has ongoing CAR-T
Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell
Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL) and CALL-1 for
adult Acute Lymphoblastic Leukemia (ALL), utilizing CBMG’s
proprietary and optimized CD19 construct, a Phase IIb trial in
China for RejoinTM
autologous Human Adipose-derived
Mesenchymal Progenitor Cell (haMPC) for the treatment of Knee
Osteoarthritis (KOA) as well as a Phase I trial in China for
AlloJoin™ (CBMG’s “Off-the-Shelf” haMPC)
for the treatment of KOA. In Q1 2018 CBMG was added to 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 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.
Contacts:
Sarah Kelly
Director of Corporate Communications, CBMG
+1 650 566-5064
sarah.kelly@cellbiomedgroup.com