Cellular Biomedicine Group (CBMG) Approved to Commence Phase I Trial (CARD-1) for C-CAR011 in Patients with Refractory Diffus...
November 29 2016 - 7:16AM
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
CARD-1 (“CAR-T Against DLBCL”) 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
refractory Diffuse Large B-cell Lymphoma (DLBCL). The CARD-1 trial
has begun enrollment with final data expected to be available in
the second half of 2017. Based on the CARD-1 results, CBMG expects
to initiate a larger Phase II clinical trial as soon as
practicable.
“Our CARD-1 trial represents the first
CBMG-sponsored clinical trial after CBMG’s acquisition of its CAR-T
technology and data from the PLA General Hospital (PLAGH, also
known as 301 Hospital) in Beijing. We are proud of this major
corporate milestone where CBMG has taken existing technology and
improved it with proprietary optimization and initiated new
clinical trials in China,” said Tony (Bizuo) Liu, Chief Executive
Officer of CBMG. “We believe we are one of the very few companies
that uniquely possesses internal viral vector production and
transduction capabilities within our own integrated GMP facility.
This allows CBMG to move quickly and efficiently from R&D to
manufacturing CAR-T cells for clinical use.”
According to a recent large, multi-cohort
dataset analysis, patients with refractory DLBCL have clinical
response rates of only 20%-30% with a median overall survival of
approximately six months. These poor refractory DLBCL patient
outcomes represent a significant unmet medical need. CBMG’s CARD-1
Phase I dose-escalation trial will use the traditional 3x3 design
to evaluate the safety, efficacy and persistence of C-CAR011 in
refractory DLBCL patients.
“DLBCL is the largest subtype of Non-Hodgkin
Lymphoma (NHL), and those refractory patients whose treatment has
failed have limited options and a very poor prognosis compared to
relapsed patients who had previously responded to treatment,” said
Dr. Jianyong Li from Jiangsu Provincial People’s Hospital in
Nanjing China, the Principal Investigator for the CARD-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 refractory
patients.”
“We are very excited as CARD-1 represents the
first of a planned series of clinical trials utilizing CBMG’s
optimized CAR-T drug candidates,” said Dr. Yihong Yao, Chief
Scientific Officer of CBMG. “We look forward to announcing
additional trials and CAR-T candidates in the future.”
About the CARD-1 Clinical
TrialCARD-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. The primary end points are Dose-Limiting Toxicity (DLT) and
Treatment Emergent Adverse Events (TEAE). Secondary endpoints will
measure Overall Response Rate (Complete plus Partial Responses) at
4 weeks and 12 weeks and Disease Control Rate (Complete plus
Partial Responses plus Stable Disease) at 12 weeks according to the
International Working Group (IWG) revised criteria. The trial
summary is registered with clinicaltrials.gov under the number
NCT02976857.
The trial will be conducted by Dr. Jianyong Li
at the Jiangsu Provincial People’s Hospital in Nanjing China. The
Jiangsu Provincial People’s Hospital (also known as the First
Affiliated Hospital of Nanjing Medical University, Jiangsu Clinical
Medicine Research Institute and the Red Cross Hospital of Jiangsu)
was founded in 1936 and performs medical treatment, provides
education, and conducts advanced research. The hospital has 3,000
beds and over 4,000 employees with total floor space of 3 million
square feet covering 50 acres. The Department of Clinical Medicine
of Nanjing Medical University is located inside the hospital,
offering clinical medicine doctoral degree and postdoctoral
research programs, with 45 teaching and research sections and more
than 200 professors. The hospital maintains cooperative
relationships with other research hospitals and laboratories in
countries such as the US, Japan, Canada, Australia and Italy.
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. C-CAR011 is entirely engineered and manufactured in
CBMG’s own GMP manufacturing facility in China.
About Diffuse Large B-Cell Lymphoma
(DLBCL) Diffuse Large B-Cell Lymphoma (DLBCL) is the most
common form of Non-Hodgkin Lymphoma (NHL) with DLBCL representing
approximately 30% of newly diagnosed NHL cases in the United States
and an even higher percentage of newly diagnosed NHL cases in
China. DLBCL is an aggressive form of lymphoma that advances
quickly and occurs in both men and women although slightly more
common in men. The incidence of DLBCL increases with age with most
patients over the age of 60. The current treatment options include
chemotherapy, anti-CD20 targeted therapy, radiation and stem cell
transplantation. However, for patients with refractory DLBCL
(failed to respond to treatment) the poor clinical response rates
of 20%-30% with median overall survival of approximately 6 months
represents a significant unmet medical need.
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, Grayling
+1 347 481-3711
vivian.chen@grayling.com
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