Johnson & Johnson has partnered with Cellular Biomedicine Group to advance, produce, and commercialize CAR-T cell therapies for the treatment of B-cell malignancies.
The deal sees Chinese company Cellular Biomedicine Group (CBMG) receive an upfront payment of $245 million from J&J’s subsidiary Janssen Biotech. In return, CBMG will grant Janssen access to develop and commercialize its CAR-T assets, except in Greater China. Moreover, Janssen said it will bolster its portfolio in B-cell malignancies.
The investigational CD20-directed autologous chimeric antigen receptor (CAR) T-cell therapies have shown positive complete response rates in its Phase I studies with patients who have relapsed/refractory (R/R) non-Hodgkin’s lymphoma (NHL) in China.
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“Our innovation strategy is agnostic to the source of breakthrough science, platforms, targets and medicines from the global life science ecosystem,” said Yusri Elsayed, VP, Disease Area Leader, Hematologic Malignancies, Janssen Research & Development.
“The Cellular Biomedicine Group team has discovered differentiated cell therapies with clinically validated CD20 CAR constructs, and we look forward to harnessing our expertise, capabilities and scale to lead the global development of these innovative CAR-T products.”
Cellular’s C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has been granted US Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, as well as Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with R/R Diffuse large B cell lymphoma (DLBCL).
Furthermore, C-CAR066 is a CD20 targeted CAR-T therapy that has also received US FDA IND authorization. The firm is expected to begin a Phase Ib study in the second half of this year.
“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,” said Sen Zhuang, vice president, Clinical Research and Development, Janssen Research & Development.
“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.”
J&J is familiar with the CAR-T space. The firm and its partner Legend Biotech received US FDA approval in March 2022, for CAR-T therapy Carvykti (ciltacabtagene autoleucel; ciltacel), which is used to treat white blood cell cancer. For the first three months of 2023, the multiple myeloma therapy pulled in $72 million in sales, up from $55 million quarter-on-quarter.
The closing of the transaction is subject to customary closing conditions, but it is expected to close in the second quarter of 2023.
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