Cellular Biomedicine Group Inc. (NASDAQ:CBMG) (“CBMG” or the
“Company”), a clinical-stage biopharmaceutical firm engaged in the
development of effective immunotherapies for cancer and stem cell
therapies for degenerative diseases, announced today that the
governing Board of the California Institute for Regenerative
Medicine (CIRM), California's stem cell agency, has awarded the
Company $2.29 million to support pre-clinical studies of
AlloJoinTM, CBMG’s “Off-the-Shelf” Allogeneic Human Adipose-derived
Mesenchymal Stem Cells for the treatment of Knee Osteoarthritis in
the United States.
While 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 AlloJoinTM in Knee Osteoarthritis (KOA), this
latest announcement represents CBMG’s initial entrance into the
United States for its “off-the-shelf” allogeneic stem cell
candidate AlloJoinTM.
The $2.29 million was granted under the CIRM 2.0
program, a comprehensive collaborative initiative designed to
accelerate the development of stem cell-based treatments for people
with unmet medical needs. After the award, CIRM will be a more
active partner with its recipients to further increase the
likelihood of clinical success and help advance a pre-clinical
applicant’s research along a funding pipeline towards clinical
trials. CBMG’s KOA pre-clinical program is considered late-stage,
and therefore it meets CIRM 2.0’s intent to accelerate support for
clinical stage development for identified candidates of stem cell
treatments that demonstrate scientific excellence.
"We are deeply appreciative to CIRM for their
support and validation of the therapeutic potential of our KOA
therapy,” said Tony (Bizuo) Liu, Chief Executive Officer of CBMG.
“We thank Dr. C. Thomas Vangsness, Jr., in the Department of
Orthopaedic Surgery at the Keck School of Medicine of the
University of Southern California and Dr. Qing Liu-Michael at the
Broad Center for Regenerative Medicine and Stem Cell Research at
USC, who helped significantly with the grant application process.
The CIRM grant is the first step in bringing our allogeneic human
adipose-derived mesenchymal stem cell treatment for knee
osteoarthritis (AlloJoinTM) to the U.S. market.
Our AlloJoinTM program has previously undergone
extensive manufacturing development and pre-clinical studies and is
undergoing a Phase I clinical trial in China. In order to
demonstrate comparability with cell banks previously produced in
China for our U.S. IND filing, we are addressing the pre-clinical
answers required for the FDA. With the funds provided by CIRM, we
will replicate and validate the manufacturing process and control
system at the cGMP facility located at Children’s Hospital Los
Angeles to support the filing of an IND with the FDA. The outcome
of this grant will enable us to have qualified final cell products
ready to use in a Phase I clinical trial with Dr. Vangsness as the
Principal Investigator and the Keck School of Medicine of USC as a
trial site. Dr. Vangsness is familiar with both stem cell biology
and KOA, and has led the only randomized double-blind human
clinical study to investigate expanded allogeneic mesenchymal stem
cells to date. Our endeavor in the U.S. market will further
strengthen our commercialization pipeline.”
CBMG recently announced promising interim
3-month safety data from its Phase I clinical trial in China for
AlloJoinTM, its off-the-shelf allogeneic stem cell therapy for KOA.
The trial is on schedule to be completed by the third quarter of
2017.
About CIRM
At CIRM, we never forget that we were created by
the people of California to accelerate stem cell treatments to
patients with unmet medical needs, and to act with a sense of
urgency commensurate with that mission. To meet this challenge, our
team of highly trained and experienced professionals actively
partners with both academia and industry in a hands-on,
entrepreneurial environment to fast track the development of
today's most promising stem cell technologies.
With $3 billion in funding and over 280 active
stem cell programs in our portfolio, CIRM is the world's largest
institution dedicated to helping people by bringing the future of
medicine closer to reality.
For more information, please visit
www.cirm.ca.gov.
About Knee Osteoarthritis
According to the Foundation for the National
Institutes of Health, there are 27 million Americans with
Osteoarthritis (OA), and symptomatic Knee Osteoarthritis (KOA)
occurs in 13% of persons aged 60 and older. The International
Journal of Rheumatic Diseases, 2011 reports that approximately 57
million people in China suffer 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
relieve symptoms and carry the risk of side effects. Patients with
KOA suffer from compromised mobility, leading to sedentary
lifestyles; doubling the risk of cardiovascular diseases, diabetes,
and obesity; and increasing the risk of all causes of mortality,
colon cancer, high blood pressure, osteoporosis, lipid disorders,
depression and anxiety. According to the Epidemiology of Rheumatic
Disease (Silman AJ, Hochberg MC. Oxford Univ. Press, 1993:257), 53%
of patients with KOA will eventually become disabled.
About Cellular Biomedicine Group
(CBMG)
Cellular Biomedicine Group, Inc. develops proprietary cell
therapies for the treatment of cancer and degenerative diseases.
Our immuno-oncology and stem cell projects are the result of
research and development by CBMG’s scientists and clinicians from
both China and the United States. 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. To learn more about CBMG, please visit
www.cellbiomedgroup.com.
Forward-looking Statements
This press release contains forward-looking statements—including
descriptions of plans, strategies, trends, specific activities,
investments and other non-historical facts—as defined by 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 uncertain, and actual results could
differ materially from those anticipated due to a number of
factors, which include risks inherent in doing business, trends
affecting the global economy (including the devaluation of the RMB
by China in August 2015), and other risks detailed 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," "continue" or similar terms or
their negations. 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
+1 408-973-7884
sarah.kelly@cellbiomedgroup.com
Vivian Chen
Managing Director Investor Relations, Citigate Dewe Rogerson
+1 347 481-3711
vivian.chen@citigatedr.com
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