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Global pharmaceutical giant Johnson & Johnson has made a significant $245M investment to boost the development of next-generation CAR-T therapies. This strategic move aims to combat a variety of lymphoma types, particularly diffuse large B-cell lymphoma.
The Power Players: Janssen Biotech and Cellular Biomedicine Group
J&J's subsidiary, Janssen Biotech, has forged a worldwide collaboration and license agreement with the Chinese biotech firm Cellular Biomedicine Group (CBMG). This partnership is geared towards the evolution of CAR-T therapies, a promising new frontier in cancer treatment.
"The agreement combines Janssen and J&J’s deep hematology expertise and global infrastructure with CBMG’s “differentiated cell therapies” and “clinically validated CD20 CAR constructs,” commented Yusri Elsayed, Vice President and Disease Area Leader, Hematologic Malignancies, Janssen Research & Development.
Financial Details of the Deal
Under the terms of the deal, Janssen will shell out an upfront payment of $245M to CBMG. Additionally, CBMG is set to receive potential development, regulatory, and sales milestones. The prospective tiered royalty payments on future sales are also part of the agreement. The specific amounts for these payments have not been disclosed as of yet.
What Janssen Stands to Gain
In return for its substantial investment, Janssen will gain worldwide rights to develop and commercialize CBMG's CAR-T assets, with the exception of the Greater China region. However, both firms are still negotiating possible commercialization of these assets within China.
CAR-T Therapies: The Future of Lymphoma Treatment
The collaboration aims to leverage the promising potential of CAR-T therapies, which are being developed by CBMG. These therapies target the CD19 and CD20 antigens, commonly found on the surface of lymphocytes. In cases of B-cell malignancies, these immune cells proliferate uncontrollably, leading to cancer.
# Example of how CAR-T Therapy works
def car_t_therapy(target_antigen):
#create CAR-T cells
car_t_cells = create_car_t_cells(target_antigen)
#infuse CAR-T cells into patient
patient.infuse(car_t_cells)
#CAR-T cells destroy cancer cells
car_t_cells.destroy(cancer_cells)
The Key Assets: C-CAR039 and C-CAR066
Two particular CAR-T therapies, C-CAR039 and C-CAR066, are involved in the agreement. C-CAR039 is a bi-specific molecule that targets both CD19 and CD20 antigens. The FDA cleared the Investigational New Drug (IND) application for C-CAR039 in December 2021, paving the way for Phase Ib study in patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).
On the other hand, C-CAR066 is an optimized molecule that targets the CD20 antigen. The IND for C-CAR066 has also been cleared by the FDA, with Phase Ib assessments scheduled for the second half of 2023.
"C-CAR039 and C-CAR066 are differentiated cell-based therapies with clinically validated CD20 CAR constructs,” said Brian Kenney, Janssen’s Global Therapeutic Area and Cross-Sector Oncology Communication Leader.
A Promising Outlook
Initial Phase I studies in China have shown promising response rates in NHL, with most participants having diffuse large B-cell lymphoma. The FDA's granting of its Regenerative Medicine Advanced Therapy and Fast Track designations for C-CAR039 in January 2022 further solidifies the potential of these therapies.
A Timeline for the Future
The deal between Janssen and CBMG is expected to close in the second quarter of 2023. This landmark agreement signifies a huge leap forward in the development of effective treatments for lymphomas, establishing a hopeful outlook for the future of cancer treatment.
Partnership Formation - Janssen Biotech and Cellular Biomedicine Group
Upfront Payment - $245M by Janssen
Gaining Rights - Janssen acquires worldwide rights for CBMG's CAR-T assets
Key Assets - C-CAR039 and C-CAR066
FDA Clearance - INDs for both C-CAR039 and C-CAR066
Future Developments - Closing of the deal by Q2, 2023