CBMG Announces Amendment to Global Collaboration and License Agreement with Janssen to Include China Market for C-CAR039 and C-CAR066

December 15, 2023, Shanghai, China, Maryland, USA — Cellular Biomedicine Group (hereinafter referred to as "CBMG" or "the Company") is a global biopharmaceutical company in the clinical stage, focusing on the discovery and development of innovative patented cell therapy products.The company recently announced that it has amended the global collaboration and license agreement signed with Janssen Pharmaceuticals, Inc. (referred to as "Janssen"), a subsidiary of Johnson & Johnson.According to the revised agreement, Janssen will have the rights to commercialize the CD20-targeted chimeric antigen receptor T (CAR-T) cell products C-CAR039 and C-CAR066 in China.Currently, Cellular Biomedicine Group (CBMG) is conducting clinical research on C-CAR039 and C-CAR066 for the treatment of non-Hodgkin's lymphoma (NHL).

Chairman and Chief Executive Officer of CBT Biotech Group, Liu Bizo"We recently presented the latest clinical data for C-CAR039 and C-CAR066 at the 65th American Society of Hematology Annual Meeting. Our research data continues to demonstrate that both therapies have the potential to become best-in-class treatments for relapsed/refractory non-Hodgkin lymphoma (r/rNHL). The Center for Drug Evaluation of the National Medical Products Administration has approved the Investigational New Drug (IND) application for C-CAR039, and we are currently conducting Phase Ib clinical trials. The combination of CBMG’s clinical development and manufacturing capabilities along with Janssen Pharmaceuticals’ global commercialization strengths will maximize the potential of C-CAR039 and C-CAR066, providing innovative and life-changing therapeutic solutions for patients in China and around the world."

Under the terms of the agreement, Janssen Pharmaceuticals will pay a priority option exercise fee to AbelZeta Pharma upon exercise, and AbelZeta Pharma will receive milestone payments after achieving commercialization and sales milestones.

About the Research

C-CAR039 is a novel bispecific CAR-T product targeting both CD19 and CD20. It has received IND approval from the U.S. FDA, as well as Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track status, for the treatment of relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL) patients. A Phase 1b trial being conducted in the United States is currently evaluating the efficacy of C-CAR039 in treating r/r DLBCL patients.

C-CAR066 is an optimized novel CD20-targeted CAR-T product, which has also received IND approval from the U.S. FDA and is currently undergoing a Phase 1b study in the United States for r/r DLBCL patients (including those who previously failed CD19 CAR-T treatment).

About NHL and DLBCL

Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy globally. In most countries and regions worldwide, non-Hodgkin lymphoma ranks between fifth and ninth among common malignant tumors; in 2020, there were approximately 544,000 new cases of non-Hodgkin lymphoma globally, with 260,000 deaths.[1]

Diffuse Large B-Cell Lymphoma (DLBCL) is a common aggressive non-Hodgkin lymphoma, accounting for one in every three cases of NHL. Under existing first-line treatment regimens, many patients still experience relapse or are inherently refractory (resistant to treatment) DLBCL. Treatment options for relapsed/refractory DLBCL are limited, and the risk of mortality is high. For patients who relapse or show no response to initial treatment, traditional treatment options that can achieve durable remission are limited, with a median life expectancy of approximately six months. Therefore, there is an urgent need for new treatment approaches.。[2,3]

1.Mafra A, Laversanne M, Gospodarowicz M, Klinger P, De Paula Silva N, Piñeros M, Steliarova-Foucher E, Bray F, Znaor A. Global patterns of non-Hodgkin lymphoma in 2020. Int J Cancer. 2022 Nov 1;151(9):1474-1481. doi: 10.1002/ijc.34163. Epub 2022 Jul 2. PMID: 35695282.

2.Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808.

3.Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70.