NEW YORK – Janssen on Wednesday said it will pay Cellular Biomedicine Group (CBMG) $245 million upfront in a licensing and collaboration deal focused on developing, manufacturing, and commercializing CAR T-cell therapies for B-cell malignancies.
The agreement gives Janssen rights to CBMG's CAR T-cell therapy assets worldwide, except in greater China, though the companies may negotiate an option for Janssen to commercialize the products in that territory. In the deal, CBMG is also eligible for future development, regulatory, and sales milestone payments, plus tiered royalties on net trade sales.
Rockville, Maryland-based CBMG is presently developing a bispecific CAR T-cell therapy, C-CAR039, which targets CD19 and CD20 antigens. The US Food and Drug Administration has cleared CBMG's investigational new drug (IND) application for the treatment, a regenerative medicine advanced therapy, and granted the drug fast-track designation as a treatment for patients with relapsed or refractory diffuse large B-cell lymphoma.
In a Phase I clinical trial in China, 12 out of 13 patients with non-Hodgkin lymphoma treated with C-CAR039 responded within one month. Of the 11 patients with DLBCL in the study, all responded. A US-based Phase Ib study of C-CAR039 in patients with relapsed or refractory non-Hodgkin lymphoma is underway.
CBMG's other investigational CAR T-cell therapy, the CD20-targeted C-CAR066, has received IND clearance from the FDA. The company will begin a Phase Ib study of C-CAR066 in the second half of 2023.
Janssen estimated that the collaboration with CBMG will have approximately a 10 cent negative impact on earnings per share in 2023 and 2024. This charge will be realized largely in the second quarter of 2023, the company said, but maintained its guidance for 2023. For the full year, parent company Johnson & Johnson last month said it is expecting sales in the range of $97.9 billion to $98.9 billion and adjusted EPS between $10.60 and $10.70.