Takeda Pharmaceutical Co. Ltd. expanded its cell therapy manufacturing capabilities with the opening of a new 24,000 sq.-ft. R&D cell therapy manufacturing facility at its R&D headquarters in Boston, MA. The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through Phase 2b trials. The cGMP facility is designed to meet all U.S., E.U. and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world. It expands Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with collaborators including Nobel Laureate Shinya Yamanaka, M.D., Ph.D., Kyoto University (induced pluripotent stem cells), Adrian Hayday, Ph.D., Gamma Delta Therapeutics (gamma delta T-cells), Koji Tamada, M.D., Ph.D., Noile-Immune Biotech (armored CAR-Ts), Michel Sadelain, M.D., Ph.D., Memorial Sloan Kettering Cancer Center (next-generation CARs), and Katy Rezvani, M.D., Ph.D., The University of Texas MD Anderson Cancer Center (CAR-NK).
Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).
Two additional Phase 1 studies of Takeda cell therapy programs are also underway: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors.