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, today announced that the Company has entered into a global collaboration and license agreement with Janssen Biotech, Inc.
| ROCKVILLE, Md., May 2, 2023 /PRNewswire/ -- 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, today 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).
“We feel privileged to work with Janssen to advance the promise of our innovative medicines.” 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. “We are very excited to announce the C-CAR039 and C-CAR066 CAR-T collaboration and license agreement with Janssen to develop and commercialize our novel CAR-T therapies,” said Tony (Bizuo) Liu, Chairman and CEO of CBMG. “The updated clinical data for both C-CAR039 and C-CAR066 continue to support the view that both CAR-T assets have the potential to be best in disease and best in class in r/r NHL to address significant unmet medical needs globally. We are thrilled that through this collaboration we will be able to expand the potential of these promising NHL drug candidates in the hope of helping patients worldwide. We feel privileged to work with Janssen to advance the promise of our innovative medicines.” About Non-Hodgins’s lymphoma Diffuse large B-cell lymphoma is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.2,3 About CBMG Forward-Looking Statements References
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