Cellular Biomedicine Group Inc. and Janssen Biotech, Inc. Announce Global Collaboration for CAR-T Therapies

China-based cell therapy specialist Cellular Biomedicine Group Inc. (CBMG), emerging from a merger deal in February 2021, has announced a significant global collaboration and license agreement with US firm Janssen Biotech, Inc. (Janssen). The partnership is centered on the development and commercialization of C-CAR039, an anti-CD19 and CD20 bi-specific chimeric antigen receptor T-cell (CAR-T) therapy, and C-CAR066, an anti-CD20 CAR-T, both intended for the treatment of non-Hodgkin lymphoma (NHL).

Exclusive Licensing and Development Rights for Janssen
Under the agreement’s terms, Janssen will secure an exclusive license to develop and commercialize C-CAR039 and C-CAR066 in geographic territories outside of China. Negotiations are underway for an option that would allow Janssen to develop these therapies within the China territory, subject to meeting certain deadlines prior to CBMG filing the Biologics License Application (BLA) in China. In return, CBMG will receive an upfront payment of USD 245 million, with additional undisclosed milestone payments to follow. Post-commercialization, CBMG will also be entitled to royalties on Janssen’s net sales.

FDA Designations and Theraputical Advancements
Both C-CAR039 and C-CAR066 have received clearance from the US Food and Drug Administration (FDA) for Investigational New Drug applications. The FDA has granted C-CAR039 Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL). Moreover, C-CAR039 has also been designated as an Orphan Drug by the FDA for the treatment of follicular lymphoma (FL), highlighting the potential impact of these therapies on patients in need.-Fineline Info & Tech

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