Jan 12, 2022
CBMG Receives FDA Regenerative Medicine Advanced Therapy and Fast Track Designations
Rockville, Maryland – January 12th, 2022 – Cellular Biomedicine Group Inc. (CBMG or the “Company”), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens, both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
“This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rates in r/r DLBCL. The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR-T asset for patients in this indication. We are working towards initiating 1b/2 trials for C-CAR039 in the US soon. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU,” said Tony (Bizuo) Liu, Chairman and CEO.
Early clinical results of C-CAR039 from an investigator-initiated trial (IIT) conducted across multiple sites in China demonstrate exciting efficacy and favorable safety data of C-CAR039 in r/r B-cell NHL. As of April 20, 2021, a total of 34 patients received C-CAR039 cell therapies, with 28 patients evaluable for safety analyses and 27 patients evaluable for efficacy analyses. Patients’ median age was 55.5 years, and 75% had cancer of Ann Arbor stage III/IV. Patients had a median of three prior lines of therapy. Bridging therapy had been given to 17.9% of patients. The best overall response rate (ORR) was reported to be 92.6%, with a complete response rate (CRR) of 85.2%. Patients had a median time to response of 1.0 month, and at a median follow-up of 7 months, 74.1% of patients continued to be in complete remission. The 6-month estimated progression-free survival rate was 83.2% (95% CI, 69.1%-100.0%). Cytokine release syndrome (CRS) occurred in 96% of patients. 92% of CRS was of grade 1/2 and only 1 patient had grade 3 CSR. Immune effector cell-associated neurotoxicity syndrome occurred at grade 1 in 2 patients and no ≥grade 2 neurologic events reported in the study. CBMG will continue to evaluate patients with longer follow-up (ClinicalTrials.gov Identifiers: NCT04317885, NCT04655677, NCT04696432, NCT04693676).
Separately, in June 2021, the FDA Office of Orphan Products Development granted CBMG an Orphan Drug Designation to C-CAR039 for the treatment of Follicular Lymphoma, an indolent form of non-Hodgkin lymphoma. The FDA cleared the IND for C-CAR039 on December 10th, 2021.
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.
Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. 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 any risks detailed from time to time in CBMG Holding’s reports, including risks relating to the impact of the COVID-19 pandemic on our operations, including risks associated with the evolving COVID-19 pandemic and actions taken in response to it. Such statements are based on the current beliefs and expectations of the management of the Company and are subject to significant risks and uncertainties outside of the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, CBMG Holdings does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
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