Cellular Biomedicine Group (CBMG) Approved to Commence Phase I Trial (CALL-1) for C-CAR011 in Adult Patients with Relapsed or...
January 09 2017 - 6:11AM
Cellular Biomedicine Group Inc. (NASDAQ: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
TrialCALL-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-CAR011CBMG’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
StatementsStatements 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
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