Attached files
file | filename |
---|---|
8-K - CURRENT REPORT - Cellular Biomedicine Group, Inc. | cbmg_8k.htm |
EXHIBIT
99.1
Cellular
Biomedicine Group Awarded $2.29 Million Grant from the California
Institute for Regenerative Medicine (CIRM) to Fund
AlloJoinTM
Allogeneic Stem Cell Therapy for Knee Osteoarthritis (KOA) in the
U.S.
SHANGHAI, China and
CUPERTINO, Calif., Feb. 27, 2017 — Cellular Biomedicine Group
Inc. (“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