Janssen Biotech, Cellular Biomedicine Group collaborate to develop next generation CAR-T therapies

C-CAR066 is an optimized novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with R/R DLBCL is anticipated to begin in the second half of 2023.

“We are committed to advancing the science and treatment of B-cell malignancies, especially in DLBCL where deeper responses and long-term remissions represent a persistent unmet need,” said Sen Zhuang, M.D., Ph.D., Vice President, Clinical Research and Development, Janssen Research & Development, LLC. “A tenet to our continued innovation is a focus on accelerating the development of cell therapies as we strive to profoundly transform patient outcomes and, ultimately, progress potentially curative regimens.”

"Through the collaboration, Janssen enhances its portfolio in B-cell malignancies and strengthens its more than two-decade legacy in hematology, while deepening its commitment to accelerate development, manufacturing and commercialization capabilities to deliver best-in-class cell therapies," the release stated.

Under terms of the agreement, CBMG will grant Janssen a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. Janssen and CBMG will negotiate an option for Janssen to commercialize the products in the China territory. Janssen will make an upfront payment of $245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon the achievement of certain development, regulatory and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China.

Johnson & Johnson estimates that this collaboration, licensing agreement and development program will have an annual approximate 10 cent negative impact on earnings per share (EPS) in 2023 and 2024. The charge will largely apply to the second quarter and the company is maintaining its 2023 guidance. The closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close in the second quarter of 2023.

“Our innovation strategy is agnostic to the source of breakthrough science, platforms, targets and medicines from the global life science ecosystem,” said Yusri Elsayed, M.D., M.HSc., Ph.D., Vice President, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development, LLC. “The Cellular Biomedicine Group team has discovered differentiated cell therapies with clinically validated CD20 CAR constructs, and we look forward to harnessing our expertise, capabilities and scale to lead the global development of these innovative CAR-T products.”

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