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8-K - CURRENT REPORT - Cellular Biomedicine Group, Inc. | cbmg_8k.htm |
Exhibit 99.1
Cellular Biomedicine Group (CBMG) Announces the Addition of a
Second Clinical Site in the Expansion of its Chimeric Antigen
Receptor T-cell (CAR-T) Phase I Clinical Trial for Its CARD-1 Trial
in Patients with Non-Hodgkin Lymphoma (NHL)
SHANGHAI, China and CUPERTINO, Calif., May 15,
2017 /GlobeNewswire/ — 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, today announced the addition of a new
independent Phase I clinical trial of the Company’s ongoing
CARD-1 study in patients with chemorefractory and aggressive DLBCL.
The Company and Shanghai Tongji Hospital (Tongji) are conducting a
single arm, non-randomized study to evaluate the safety and
efficacy of C-CAR011 (Anti-CD19 single-chain variable fragment
(scFv) (41BB-CD3f)) therapy in relapsed or refractory B cell
Non-Hodgkin Lymphoma (NHL). The trial will enroll 15 patients
comprised of DLBCL, Primary Mediastinal Large B-Cell Lymphoma
(PMBCL) and Follicular Lymphoma (FL).
“Driven by Shanghai’s regional demand, Tongji’s
CAR-T expertise, the requirement to confirm site to site
consistency and our need to prepare for the next phase of a
confirmatory clinical trial, the new trial will benefit patients in
Shanghai and provide CBMG with incremental data in safety and
tolerability of C-CAR011 in more chemorefractory and aggressive
DLBCL patients comprised of unique histogenesis and those with the
most common indolent form of non-Hodgkin lymphoma (NHL). ”
said Mr. Tony Liu, Chief Executive Officer for CBMG.
Mr. Tony Liu added, “Due to our robust clinical pipeline, we
believe the Company’s stock is currently undervalued. The
management and our scientific team are committed to delivering
long-term clinical benefits to patients that have the potential to
address very large cancer and knee osteoarthritis markets and
create long-term value for shareholders. We believe that CBMG has
one of the very few leading integrated chemistry, manufacturing,
and controls (CMC) facilities in the world for a cell therapy
company, which when fully built out in China, will have the
manufacturing capacity to support the treatment of 10,000 cancer
and 10,000 knee osteoarthritis patients per year. With a healthy
balance sheet and an efficient deployment of capital that will
enable CBMG to execute on its clinical developments over the next
twelve months, we are well equipped to further our clinical trials
including the addition of new cancer indications by adding more top
cancer centers in China for DLBCL and ALL trials using our C-CAR011
product. As a reminder, each year China has approximately five
million new cancer patients, which far surpasses the U.S. We
are pleased with our CAR-T patient screening and trial enrollment
progress thus far and are on track to share our topline clinical
data in the fourth quarter of this year as it becomes available. We
look forward to evaluating new interests in expanding our clinical
development and CAR-T partnerships with leading hospitals in major
cities in China.”
2017 Business & Technology Highlights
●
In 2016, commenced
patient enrollment in China for its CARD-1 (“CAR-T Against
DLBCL”) Phase I clinical trial utilizing CBMG’s
optimized proprietary C-CAR011 construct of CD19 chimeric antigen
receptor T-cell (CAR-T) therapy for the treatment of patients with
refractory Diffuse Large B-cell Lymphoma (DLBCL);
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●
Announced addition
of second clinical trial site for its
Chimeric Antigen Receptor T-cell (CAR-T) Phase I Clinical Trial for
its CARD-1 Trial in patients with refractory Diffuse Large B-cell
Lymphoma (DLBCL) in Shanghai with Tongji
Hospital;
●
Commenced
CALL-1 (“CAR-T against Acute Lymphoblastic Leukemia”)
Phase I clinical trial in China utilizing its optimized proprietary
C-CAR011 construct of CD19 chimeric antigen receptor T-cell (CAR-T)
therapy for the treatment of patients with relapsed or refractory
(r/r) CD19+ B-cell Acute Lymphoblastic Leukemia (ALL);
●
Received the first disbursement of $1.2 million in
the $2.29 million grant by California Institute for Regenerative
Medicine (CIRM), California’s stem cell agency, 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;
●
Completed
expansion of its 30,000 square foot facility in Huishan High Tech
Park in Wuxi, China, with 20,000 square feet of the Wuxi GMP
facility dedicated to advanced stem cell culturing, centralized
plasmid and viral vector production, cell banking and development
of reagents;
●
Began
construction of a new GMP facility in “Pharma Valley”
in Shanghai Zhangjiang High-Tech Park, which will consist of 40,000
square feet dedicated to advanced cell manufacturing;
●
Established
a strategic research collaboration with GE Healthcare Life Sciences
China to co-develop certain high-quality industrial control
processes in Chimeric Antigen Receptor T-cell (CAR-T) and stem cell
manufacturing, and form a joint laboratory within CBMG’s new
Shanghai Zhangjiang GMP-facility dedicated to the joint
research and development of a functionally integrated and automated
immunotherapy cell preparation system.
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. 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
(CBMG’s
“Off-the-Shelf” Allogeneic Human Adipose-derived
Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis
(KOA). CBMG was recently awarded $2.29 million from the California
Institute for Regenerative Medicine (CIRM) to support pre-clinical
studies of AlloJoinTM
for Knee Osteoarthritis in the United
States. The Company also recently announced a strategic partnership
with GE Healthcare Life Sciences China to establish a joint
technology laboratory to develop control processes for the
manufacture of CAR-T and stem cell therapies. To learn more about
CBMG, please visit www.cellbiomedgroup.com.
About Shanghai Tongji Hospital
Established in 1900,
Shanghai
Tongji Hospital, a AAA General
Hospital in Shanghai, China, is affiliated with Tongji University,
one of the oldest and most prestigious universities in China.
The hospital comprises 52 clinical and paramedical departments with
a total of 4,000 beds and over 4,500 employees. The Department of
Rehabilitation is designated as a training and research center of
World Health Organization (WHO). The hospital maintains
cooperative relationships with other research hospitals and
laboratories in many countries including Germany, USA, Japan and
France. It has published more research papers than any other
medical institution in China.
About PMBCL & FL
Primary mediastinal B-cell lymphoma (PMBCL) belongs to the group of
aggressive diffuse large B-cell lymphomas. Its molecular signature
and clinical features resemble classical Hodgkin lymphoma. It
constitutes approximately 2 % to 4 % of all non-Hodgkin
lymphomas (around 6 % of diffuse large B-cell lymphomas
(DLBCL)).
Follicular lymphoma (FL) is the most
common indolent (slow- growing) form of NHL, accounting
for approximately 12 percent of all B-cell NHLs.
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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 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 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 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
+1 408-973-7884
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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