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 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.
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.
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.
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
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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