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 Trial
CARD-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.
CARD-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-CAR011
CBMG’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.
CBMG’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.
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
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
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