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EX-99.2 - PRESENTATION - Cellular Biomedicine Group, Inc. | cbmg_ex992.htm |
8-K - CURRENT REPORT - Cellular Biomedicine Group, Inc. | cbmg_8k.htm |
Exhibit 99.1
Cellular Biomedicine Group (CBMG) Approved to Commence Phase I
Trial (CALL-1) for C-CAR011 in Adult Patients with Relapsed or
Refractory B-cell Acute Lymphoblastic Leukemia (ALL) in
China
SHANGHAI,
China and CUPERTINO, Calif., January 9, 2017 /GlobeNewswire/ --
Cellular Biomedicine Group Inc. (CBMG) (“CBMG” or the
“Company”), a clinical-stage biomedicine firm engaged
in the development of effective immunotherapies for cancer and stem
cell therapies for degenerative diseases, is pleased to announce
the approval and commencement of patient enrollment in China for
its CALL-1 (“CAR-T against Acute Lymphoblastic
Leukemia”) Phase I clinical trial 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). The CALL-1 trial has begun enrollment with final data
expected to be available at the end of 2017. Depending on the Phase
I CALL-1 results, CBMG expects to initiate a larger Phase II
clinical trial as soon as practicable.
“Our
CALL-1 trial represents the second CBMG-sponsored clinical trial
after the recent launch of our CARD-1 trial in refractory DLBCL
patients. This is another major corporate milestone and
demonstrates CBMG’s ability to execute on our immuno-oncology
plan and to forward our prioritized assets into clinical
development in China,” said Tony (Bizuo) Liu, Chief Executive
Officer of CBMG.
CBMG’s
CALL-1 Phase I dose-escalation trial will use the 3+3 design to
evaluate the safety, efficacy and persistence of C-CAR011 in CD19+
r/r ALL patients.
“Relapsed
or refractory CD19+ adult ALL patients have limited options and
poor prognosis,” said Dr. Li Yu from the PLA General Hospital
(“PLAGH”), the Principal Investigator for the CALL-1
trial. “I am excited to be able to participate in the trial
of C-CAR011 which may someday provide a treatment option for these
patients.”
“We
are excited to launch this trial to better understand the potential
C-CAR011 can have to address a large cancer population in
China,” said Dr. Yihong Yao, Chief Scientific Officer of
CBMG.
About the CALL-1 Clinical Trial
CALL-1
is a Phase I single-site, single-arm dose-escalating trial
consisting of three patient cohorts using escalating C-CAR011 cell
dosing levels with three patients in each cohort. Phase I dose
expansion will enroll an additional 6-12 patients to confirm the
optimal dose. The primary end points are Dose-Limiting Toxicity
(DLT) and Treatment Emergent Adverse Events (TEAE). Secondary
endpoints will measure Overall Response Rate (CR + CRi, complete
remission with incomplete hematopoietic recovery), MRD-CR rate at 8
weeks according to the NCCN Guideline Version 2.2016, Acute
Lymphoblastic Leukemia, and overall survival at 6
months.
Dr. Li
Yu, Director emeritus, Professor and Chief Physician of the
Department of Hematology at the PLAGH in Beijing, China will
conduct the trial. The PLAGH was founded in 1953 and is a
top-ranking medical center in China, integrating medical care,
education and research. The PLAGH has 125 clinical, medical and
technological departments, 4,000 patient beds with annual volumes
of more than 3.8 million outpatient visits, 110,000 admissions and
over 65,000 surgical operations performed.
About C-CAR011
CBMG’s
proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T)
construct represents advancement over CBMG’s prior CBM-C19.1
construct, which completed a human proof-of-concept trial
demonstrating an optimistic response rate with controllable
toxicities. C-CAR011 is entirely engineered and manufactured in
CBMG’s own GMP manufacturing facility in China.
About Acute Lymphoblastic Leukemia (ALL)
Acute
Lymphoblastic Leukemia (ALL), also called acute lymphocytic
leukemia, starts from the early type of white blood cells called
lymphocytes in the bone marrow. The leukemia cells then invade the
blood fairly quickly and may spread to other parts of the body,
including the lymph nodes, liver, spleen, central nervous system
(brain and spinal cord), and testicles (in males). The World Health
Organization defines "acute" when greater than 20% of the cells in
the bone marrow are blasts, which can progress quickly, and if
untreated, would likely be fatal within months. According to the
U.S. National Cancer Institute, 6,600 patients are diagnosed with
ALL in the U.S. annually. Additionally, it is estimated that
27,000 patients in China will be diagnosed with ALL annually. While
pediatric patients make up approximately 60% of the total and
achieve an 85% effective cure rate, only 40% of Adult ALL patients
achieve long-term disease-free survival.
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
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
+1 347 481-3711
vivian.chen@citigatedr.com