J&J makes $245M play to develop next-gen CAR-T therapies
Published: May 02, 2023
By Tristan Manalac
Tuesday, Johnson & Johnson subsidiary Janssen Biotech entered into a worldwide collaboration and license agreement with Chinese biotech Cellular Biomedicine Group to develop next-generation CAR-T therapies for diffuse large B-cell lymphoma.
Under the terms of the deal, Janssen will pay $245 million upfront. CBMG will also be entitled to potential development, regulatory and sales milestones as well as tiered royalty payments on future sales. The companies are not disclosing the exact amounts for these, Brian Kenney, Janssen’s global therapeutic area and cross-sector oncology communication leader, told BioSpace in an email.
In return, Janssen will gain worldwide rights to develop and commercialize CBMG’s CAR-T assets, excluding the Greater China region. However, Janssen and CBMG will still negotiate the possibility of commercializing these assets in the China territory.
The licensing deal will combine Janssen and J&J’s deep hematology expertise and global infrastructure with CBMG’s “differentiated cell therapies” and “clinically validated CD20 CAR constructs,” Yusri Elsayed, vice president and disease area leader, Hematologic Malignancies, Janssen Research & Development, said in a statement.
The companies expect to close the agreement in the second quarter of 2023.
CBMG is advancing a pipeline of CAR-T medicines targeting the CD19 and CD20 antigens, both of which are commonly expressed on the surface of lymphocytes, a type of immune cell whose proliferation becomes uncontrollable in B-cell malignancies.
C-CAR039, one of the CAR-T therapies involved in Tuesday’s deal, is a bi-specific molecule targeting both surface antigens. In December 2021, the FDA cleared the Investigational New Drug application for C-CAR039, allowing CBMG to push through with a Phase Ib study of the candidate in relapsed/refractory B-cell non-Hodgkin lymphoma (NHL).
A month later, in January 2022, the regulator also granted C-CAR039 its Regenerative Medicine Advanced Therapy and Fast Track designations in this indication.
The FDA has also cleared the IND for another CAR-T asset involved in the licensing pact. C-CAR066, an optimized molecule targeting the CD20 antigen, will enter Phase Ib assessments in the second half of 2023, according to Tuesday’s press release.
“C-CAR039 and C-CAR066 are differentiated cell-based therapies with clinically validated CD20 CAR constructs,” Kenney said, adding that Phase I studies in China have shown that these candidates induce promising response rates in NHL, with most participants having diffuse large B-cell lymphoma.
J&J has had good luck with international collaborators in cancer. In December 2017, it inked a $350 million deal with Legend Biotech, which in February 2022 paid off with an FDA approval for the CAR-T therapy Carvykti (ciltacabtagene autoleucel) for multiple myeloma.