▎This article is provided byContributed by Cellular Biomedicine Group (Shanghai) Ltd

News on December 15, Cellular Biomedicine Group (hereinafter referred to as "CBMG") announced that regardingJohnson & Johnson (Janssen（Janssen）The signed global collaboration and license agreement has been amended. According to the amended agreement,For the CD20-targeted chimeric antigen receptor T (CAR-T) cell products C-CAR039 and C-CAR066，Johnson & Johnson Innovative Pharmaceuticals will have the rights to commercialize it in China.Cellular Biomedicine Group (Shanghai) Ltd is currently conducting clinical research on C-CAR039 and C-CAR066 for the treatment of non-Hodgkin's lymphoma (NHL).

Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy globally. Diffuse large B-cell lymphoma (DLBCL) is a prevalent aggressive subtype of non-Hodgkin lymphoma. Despite current first-line treatments, many patients experience relapse or have refractory DLBCL (resistant to treatment). Treatment options for relapsed/refractory DLBCL are limited, and the mortality risk is high. For patients with relapsed or initially unresponsive disease, traditional treatment options that can achieve durable remission are scarce, underscoring the urgent need for new therapeutic approaches.

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

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

In May 2023, Janssen, a subsidiary of Johnson & Johnson, secured the exclusive development rights outside of China for two CAR-T cell therapy products, C-CAR039 and C-CAR066, as well as the priority option for development within China, through an exclusive global collaboration with Cellular Biomedicine Group (Shanghai) Ltd. According to the revised agreement,JanssenWill also obtain the commercial rights for these two products in China.

Chairman and Chief Executive Officer of Cellular Biomedicine GroupMr. Liu BizuStated: "We recently announced C-CAR039 and C-CAR066 at the 65th American Society of Hematology Annual Meeting.Latest Clinical Data"Our research data continues to show that both therapies have the potential to become the best-in-class treatments in the field of 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 a Phase 1b clinical trial. The clinical development and production capabilities of Cellular Biomedicine Group (Shanghai) Ltd, combined with Johnson & Johnson's 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."

According to the terms of the agreement, Janssen will pay Cellular Biomedicine Group (Shanghai) Ltd. an option exercise fee at the time of exercise, and CBMG will receive milestone payments upon achieving commercialization and sales milestones.

References:
[1] Cellular Biomedicine Group Announces Exclusive Worldwide Collaboration with Janssen to Develop and Commercialize Next-Generation CAR-T Cell Therapies C-CAR039 and C-CAR066 for Lymphoma. Retrieved May 02, 2023, From https://mp.weixin.qq.com/s/QpRR0k6Om4geRfhhw4Jj_w

[2] Cellular Biomedicine Group (Shanghai) Ltd Announces Inclusion of Chinese Market in Global Collaboration and License Agreement with Janssen. Retrieved Dec 15, 2023, from https://mp.weixin.qq.com/s/NPJtY40L4YFlppS3YJxj-A