Janssen will obtain an exclusive license to develop and commercialise CBMG’s C-CAR039 and C-CAR066 in geographic territories outside of China and will make a $245m upfront payment, along with milestone payments and royalties on net sales
Janssen to develop CBMG’s CAR-T therapies. (Credit: Michal Jarmoluk from Pixabay)
Janssen Biotech, a subsidiary of Johnson & Johnson, has teamed up with Cellular Biomedicine Group (CBMG) to develop, manufacture and market new-generation CAR T-cell therapies for B-cell malignancies.
CBMG is a biopharmaceutical company focused on the discovery and development of advanced cellular therapies to treat cancer and autoimmune diseases.
The collaboration will focus on CBMG’s C-CAR039, a bi-specific CAR-T therapy that targets CD19 and CD20, and C-CAR066, an investigational CAR-T to treat Non-Hodgkin Lymphoma (NHL).
CBMG chairman and CEO Tony Bizuo Liu said: “We are very excited to announce the C-CAR039 and C-CAR066 CAR-T collaboration and license agreement with Janssen to develop and commercialise our novel CAR-T therapies.
“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.”
Under the terms of the agreement, Janssen will obtain an exclusive license to develop and commercialise CBMG’s C-CAR039 and C-CAR066 in geographic territories outside of China.
The parties will negotiate an option for Janssen to develop the candidates in China, subject to deadlines before CBMG files the Biologics License Application (BLA) application in China.
CBMG will transfer IND and studies for C-CAR039 and C-CAR066 to Janssen, along with initial clinical trial materials, including viral vector and plasmid, and technology transfer.
Janssen will make a $245m upfront payment, milestone payments upon achieving certain clinical development, regulatory filing, commercialisation and sales milestones, and royalties on net sales.
The transaction is expected to be completed in the second quarter of this year, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Act.
Janssen said that the collaboration will enhance its portfolio in B-cell malignancies, strengthen its capabilities in haematology and deliver best-in-class cell therapies.
The collaboration, licensing agreement and development programme will have a negative impact on its earnings per share (EPS) in 2023 and 2024, said the company.
Janssen Research & Development clinical research and development vice president Sen Zhuang said: “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.
“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.”