CBMG Holdings Announces Data from Two CAR-T Clinical Studies Selected for Podium Presentations at ASCO Annual Meeting

HONG KONG, June 1, 2021 /PRNewswire/ -- CBMG Holdings, a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced the publication of two abstracts of CAR-T therapies for liquid tumors published in conjunction with the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, to be held June 4-8, 2021. These abstracts will be presented at the upcoming ASCO meeting as podium presentations.

Session: Developmental Therapeutics—Immunotherapy
Abstract #: 2507
Citation: J Clin Oncol 39, 2021 (suppl 15; abstr 2507)
DOI: 0.1200/JCO.2021.39.15_suppl.2507
Drug name: C-CAR039
Mechanism of Action: A 2nd generation novel bi-specific CAR-T therapy targeting both CD19 and CD20 antigens
Indications: Relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL)

C-CAR039 has been developed as a novel 2nd generation 4-1BB bi-specific CAR-T targeting both CD19 and CD20 antigens with an optimized bi-specific antigen binding domain. C-CAR039 can eradicate CD19/CD20 single or double positive tumor cells in vitro and invivo. The tissue cross reactivity and whole genome membrane proteome array studies further confirmed the specificity of C-CAR039.

C-CAR039 demonstrated a favorable safety profile and promising efficacy in this early clinical trial in patients with r/r B-NHL that might allow it to differentiate from existing therapies. The early clinical efficacy signal is encouraging and compares favorably to anti-CD19 CAR-T and peer therapies. These findings will be evaluated in more patients with longer follow-up to confirm safety, efficacy and duration of response. Clinical trial information: NCT04317885, NCT04655677, NCT04696432, NCT04693676.

View full abstract here

Session: Developmental Therapeutics—Immunotherapy
Abstract #: 2508
Citation: J Clin Oncol 39, 2021 (suppl 15; abstr 2508)
DOI: 10.1200/JCO.2021.39.15_suppl.2508
Drug name: C-CAR066
Mechanism of Action: A novel 2nd generation CAR-T therapy targeting CD20 antigen
Indications: Relapsed/refractory B-cell non-Hodgkin lymphoma (r/r B-NHL) that has failed to an anti-CD19 CAR-T therapy

A phase I clinical trial was conducted to evaluate the safety and efficacy of C-CAR066 in subjects with r/r B-NHL who were previously treated with anti-CD19 CAR-T therapy. Patients (≥ 18 years) with r/r DLBCL, r/r FL or r/r MCL, ECOG < 2 were eligible. GMP manufacture of C-CAR066 was in a serum free and fully closed semi-automatic system. A 3-day cyclophosphamide plus fludarabine regimen was followed by a single infusion of C-CAR066. Bridging therapy was allowed.

C-CAR066 has shown a favorable safety profile and promising efficacy in patients with r/r B-NHL following failure of CD19 CAR-T therapy. These results show that C-CAR066 has a different mechanism of action compared to anti-CD-19 CAR-T therapy and could provide a solution to address the unmet medical need in B-NHL patients that have failed anti-CD19 CAR-T therapy. Clinical trial information: NCT04036019

View full abstract here

About CBMG Holdings
CBMG 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. Its Shanghai facility includes a "Joint Laboratory of Cell Therapy" with GE Healthcare and a "Joint Cell Therapy Technology Innovation and Application Center" with Thermo Fisher Scientific. These partnerships focus on improving manufacturing processes for cell therapies. CBMG 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®, CBMG's "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'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 CBMG and are subject to significant risks and uncertainties outside of CBMG'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 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
Communications & Investor Relations, CBMG
Phone: (301) 825-5320
Email: sarah.kelly@cbmgholdings.com

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