January 18, 2022 – SAN DIEGO, California
Cellular Biomedicine Group, Inc. (CBMG) announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designation to C-CAR039, an autologous bi-specific CAR-T cell therapy targeting both CD19 and CD20.
C-CAR039 was granted RMAT designation for the treatment of relapsed or refractory large B-cell lymphoma and Fast Track designation for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) based on preliminary clinical evidence from an ongoing investigator-initiated trial (IIT) conducted in China.
The Chairman and CEO of CBMG, Mr. Tony (Bizuo) Liu stated, “RMAT and Fast Track Designations are remarkable milestones in the development of C-CAR039. We have observed promising efficacy in early results in China, and these designations support the futher development of C-CAR039 in the U.S. We look forward to working closely with the FDA as we strive to bring this promising new cell and gene therapy to patients in the U.S."
Managing Director of CRC Oncology, Qinhua Cindy Ru, stated, "CBMG has achieved global clinical-stage capabilities in the field of cell and gene therapy in both U.S. and China. We are very honored and excited to support CBMG to bring this innovative cell therapy to the U.S."
About C-CAR039
C-CAR039 is a novel anti-CD19/CD20 bi-specific autologous CAR-T cell therapy developed for the treatment of relapsed/refractory (r/r) B-cell non-Hodgkin lymphomas. C-CAR039 was granted Orphan Drug Designation in June 2021 for the treatment of follicular lymphoma[1] and IND clearance to proceed with clinical development in the U.S. in patients with relapsed/refractory B-cell non-Hodgkin Lymphomas in December 2021[2].
About CBMG
Cellular Biomedicine Group Inc. (CBMG) is a wholly owned subsidiary of CBMG Holdings. CBMG Holdings (“Holdings”) develops proprietary cell therapies for the treatment of cancer and degenerative diseases. CBMG operates a state-of-the-art facility in Rockville, Maryland with five GMP rooms in order to augment its global research and development capabilities and to support clinical development of multiple cell therapy platform technologies in the United States. Holdings conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. Holdings’ GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. Holdings currently conducts ongoing studies in China, for CAR-T therapies targeting blood cancers, including C-CAR039, an anti-CD19, CD20 BiCAR treatment for non-Hodgkin lymphoma (NHL) and CAR088, an anti-BCMA treatment for Multiple Myeloma, in addition to T cell receptor (TCR-T) and tumor-infiltrating lymphocytes (TIL) therapies targeting solid tumors. Holdings has completed patient treatment in a Phase II trial for AlloJoin®, its "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. To learn more about CBMG, please visit www.cellbiomedgroup.com.
About CRC Oncology
CRC Oncology is a San Diego based regulatory submission and clinical trial management and development contract research organization (CRO). CRC Oncology provides high quality services including, but not limited to, IND/NDA/BLA applications, Orphan Drug Designation requests, Fast Track Designation requests, RMAT Designation requests, early to late-phase clinical trial development, clinical trial management, and more.
For more information, visit www.crconc.com.
References
[1] FDA 授予西比曼双靶点CAR-T产品孤儿药资格认定; 西比曼生物科技微信公众号，2021年6月13日.
[2] Cellular Biomedicine Group. CBMG Receives FDA Clearance of IND Application for Bi-Specific Anti-CD19/CD20 CAR-T Cell Therapy for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma. Published December 13, 2021. https://www.prnewswire.com/news-releases/cbmg-receives-fda-clearance-of-ind-application-for-bi-specific-anti-cd19cd20-car-t-cell-therapy-for-relapsedrefractory-b-cell-non-hodgkin-lymphoma-301443153.html