CBMG Holdings' Novel Anti-CD20 CAR-T Cell Therapy Shows Promising Safety and Efficacy in Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Patients Following Relapse to an anti-CD19 CAR-T Therapy


HONG KONG, June 10, 2021 /PRNewswire/ -- CBMG Holdings (or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced early promising safety and efficacy results of C-CAR066, a novel second generation chimeric antigen receptor T (CAR-T) therapy targeting CD20 antigen in relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) that has failed to an anti-CD19 CAR-T therapy. Patients who fail anti-CD19 CAR-T therapy generally have a dismal prognosis and are an important group with high unmet medical needs. This abstract was recently presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting by the Principal Investigator (PI) of the study, Aibin Liang, M.D., Professor of Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine, China.

"C-CAR066 preliminary data has shown an early promising therapeutic index in patients with r/r B-NHL after relapsing to an anti-CD19 CAR-T therapy," said Tony (Bizuo) Liu, Chairman and CEO of CBMG Holdings. "These early clinical data suggest that C-CAR066 could potentially provide a solution to address the highly unmet medical need in B-NHL patients that have failed to respond to anti-CD19 CAR-T therapy".

About the Study
C-CAR066 is a novel second generation CAR-T therapy targeting the CD20 antigen. Preclinical studies suggest that C-CAR066 has superior anti-tumor activity compared to anti-CD20 CAR-Ts derived from scFVs of Leu16, Rituximab and Obinutuzumab, and to anti-CD19 CAR-Ts derived from scFV FMC63.

The Phase I clinical trials (NCT04036019,  NCT04316624) were conducted in Shanghai Tongji Hospital and Institute of Hematology & Blood Diseases Hospital in Tianjin, China, to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with and failed after an anti-CD19 CAR-T therapy.

Key Results:
As of April 30, 2021, 10 patients (8 DLBCL, 2 tFL) were infused with C-CAR066 at doses ranging from 2.0 x 106 to 4.8x106 CAR-T cells/kg. The manufacturing success rate was 100%. C-CAR066 was administered as a single intravenous dose after a 3-day cyclophosphamide (300mg/m2x3d) plus fludarabine (30mg/m2x3d) conditioning regimen. The median manufacturing time was 7 days and the median vein to vein time was 20 days.

Of the 10 patients enrolled in the study, the median age was 55.5 (range, 41-67) years. The median number of prior lines of therapy was 5 (range, 2-6). Two patients (20%) underwent autologous stem cell transplant (ASCT). The median duration of response to prior anti-CD19 CAR-T therapy was 2.1 months (range:0.7~12.6).

Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria. 9/10 patients experienced CRS, in which 8 were graded as either grade 1 or grade 2. One patient had grade 4 CRS and recovered after treatment with tocilizumab and corticosteroids. No patients experienced any ICANS event. Grade ≥3 neutropenia, anemia, thrombocytopenia, and infections were reported in 80%, 50%, 30%, and 10% of patients, respectively.

At a median follow-up of 4.2 months (range, 1.2-11.7), the best overall response rate was 100%, with 70.0% (7/10) reaching complete response (CR). Median time to response was 1.0 month (range, 0.9-2.7). Median time to CR was 2.7 months (range, 0.9-2.9). Median duration of response was not reached by the cutoff date. By the cutoff date, 4 patients (3 PR, 1 CR) had experienced disease progression.  Among them, two patients relapsed due to loss of CD19 and CD20 antigens on tumor cell. One patient relapsed due to the loss of CAR-T cell expansion and proliferation 2 months post C-CAR066 infusion.  6 patients continue to respond to C-CAR066 treatment at the date of the cutoff.  Among them, 4 patients remained in CR after 10 months post C-CAR066 infusion.

About CBMG Holdings
CBMG Holdings develops proprietary cell therapies for the treatment of cancer and degenerative diseases. The Company 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. The company conducts immuno-oncology and stem cell clinical trials in China using products from its integrated GMP laboratory. The Company's GMP facilities in China, consisting of twelve independent cell production lines, are designed and managed according to both China and U.S. GMP standards. The Company currently has ongoing CAR-T Phase I clinical trials in China. The China NMPA (formerly CFDA) approved the Company's IND application for a Phase II trial for AlloJoin®, its "Off-the-Shelf" allogenic haMPC therapy for the treatment of Knee Osteoarthritis (KOA), and has accepted the Company's IND application for a Phase II trial for ReJoin® autologous haMPC therapy for the treatment of KOA. 

Forward-Looking Statements
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.

Company Contact:
Sarah Kelly
CBMG Holdings
Communications & Investor Relations
Phone: (301) 825-5320
Email: sarah.kelly@cbmgholdings.com



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