Johnson & Johnson's Janssen Subsidiary Inks $245M Deal with CBMG for Two Next-Gen CAR-T Therapies Targeting B-Cell Malignancies

On May 2, Janssen Biotech, Inc., a subsidiary of Janssen Pharmaceuticals under Johnson & Johnson, announced that it had entered into a global collaboration and licensing agreement with Cellular Biomedicine Group (CBMG) to develop, manufacture, and commercialize two next-generation chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies.

According to the terms of the agreement, CBMG will grant Janssen the development and commercialization license for CAR-T assets in regions outside of Greater China. Janssen will negotiate with CBMG regarding the option to commercialize products within China. Janssen will pay an upfront fee of $245 million, additional payments tied to certain development, regulatory, and sales milestones, as well as tiered royalties on global net sales (excluding Greater China).

C-CAR039 is a novel CD19/CD20 dual-target CAR-T cell therapy product for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (r/r B-cell NHL). At the 2021 ASCO Annual Meeting, Cellular Biomedicine Group (CBMG) presented the latest clinical data for C-CAR039 in treating r/r B-cell NHL, with an overall response rate (ORR) of 92.6%, including a complete response rate (CR) of 85.2%, positioning it as a potentially best-in-class therapy.

In the United States, C-CAR039 is currently in a Phase Ib study for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). C-CAR066, an optimized novel CD20-targeted CAR-T therapy, has also received FDA IND approval in the United States and is expected to begin a Phase Ib study in R/R DLBCL patients in the second half of 2023.

Johnson & Johnson's BCMA CAR-T therapy Carvykti, introduced from Legend Biotech, has gained significant market traction due to its remarkable efficacy. It generated $72 million in sales in the first quarter of 2023. Recently leaked abstracts also suggest substantial potential for Carvykti in the early treatment of multiple myeloma. The introduction of two CAR-T products from CiboMan indicates Johnson & Johnson’s ambition to gain a competitive edge in the crowded DLBCL space with these products.

Currently, there are four CAR-T therapies approved globally for the treatment of DLBCL: Novartis' Kymriah, Gilead's Yescarta, BMS' Breyanzi, and JW Therapeutics' Relma-cel (China).

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