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.
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