Cellular Biomedicine Group Announces Exclusive Collaboration and License Agreement with Janssen to Develop and Commercialize anti CD19 & CD20 Bi-Specific and anti CD20 CAR-Ts for Non-Hodgkin Lymphoma

Cellular Biomedicine Group Inc. (CBMG or the Company), a clinical-stage biopharmaceutical company focused on discovery and development of innovative cellular therapies for cancer and autoimmune diseases, announced that the Company has entered into a global collaboration and license agreement with Janssen Biotech, Inc. (Janssen) for C-CAR039, an anti-CD19 & CD20 bi-specific chimeric antigen receptor T-cell (CAR-T) therapy, and C-CAR066, an anti-CD20 CAR-T, which have been studied for the treatment of Non-Hodgkin Lymphoma (NHL).

The U.S. Food and Drug Administration (FDA) has granted C-CAR039 Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation for relapsed/refractory Diffuse Large B-cell Lymphoma (r/r DLBCL). Furthermore, C-CAR039 has also received Orphan Drug designation from the FDA for the treatment of Follicular lymphoma (FL). Both C-CAR039 and C-CAR066 have received FDA Investigational New Drug application clearance.

Under the terms of the agreement, Janssen will receive an exclusive license to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China, and the parties will negotiate an option for Janssen to develop the China territory subject to certain deadlines before the Company files the Biologics License Application (BLA) application in China. CBMG will transfer IND and studies for C-CAR039 (NCT05421663) and C-CAR066 (NCT05784441) to Janssen and will supply the initial clinical trial materials comprised of viral vector and plasmid, as well as assist Janssen on the technology transfer. CBMG will receive a $245 million upfront payment and milestone payments upon certain clinical development, regulatory filing, commercialization and sales achievements. After commercialization CBMG will also receive royalties on Janssen net sales. The transaction is subject to customary closing conditions and antitrust clearance.