cGMP Facility Builds Takeda’s Leadership Capabilities in Cell Therapy and Increases its Capacity to Supply Innovative Cell Therapies for Global Clinical Trials
Five Collaborative Oncology Cell Therapy Programs Expected to be in Clinical Development by the End of FY2021
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. 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.
“We are collaborating with some of the best scientists and innovators around the world establishing a highly differentiated immuno-oncology pipeline leapfrogging into new modalities and mechanisms with curative potential,” said Chris Arendt, Ph.D., Head of Takeda’s Oncology Therapeutic Area Unit. “With three oncology cell therapy programs in the clinic and two more targeted to enter the clinic in fiscal year 2021, we are working with urgency and purpose for patients. This new facility helps us rapidly scale our manufacturing capabilities so we can simultaneously advance multiple highly differentiated cell therapy programs.”
Oncology cell therapy is a type of immunotherapy that uses genetically modified immune cells to find and kill cancer cells. Because cell therapies are engineered from living cells, they need to be manufactured in a highly regulated environment to maintain cleanliness, consistency and contamination control. Each oncology cell therapy platform has unique process requirements for how they are formulated, manufactured, transported and ultimately administered to patients. Next-generation cell therapy is one of the multiple investigational platforms that Takeda is researching in oncology as part of its focus on redirected immunity. Takeda’s pipeline of diverse immuno-oncology programs harnesses innate immunity, including through innovative cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses.
A Purpose-Built Facility to Rapidly Advance Cell Therapy Research & Development
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (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 will be instrumental in building Takeda’s cell therapy capabilities and capacity to advance multiple next-generation oncology cell therapy platforms and programs with world-class 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 were also recently initiated: 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. Dr. Sadelain and MSK have intellectual property rights and associated interests related to the content of this release by virtue of licensing agreements between MSK and Takeda.
Harnessing the Power of Takeda’s Cell Therapy Translational Engine
Proactive and deep collaboration between research and development and commercial manufacturing is critical to developing and delivering next-generation cell therapies. Takeda’s Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development and commercialization. It provides bioengineering, chemistry, manufacturing and control (CMC), data management, analytical and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.
“The proximity and structure of our cell therapy teams allow us to quickly apply what we learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts and gamma delta T cells, among others,” said Stefan Wildt, Ph.D., Head of Pharmaceutical Sciences and Translational Engine, Cell Therapies at Takeda. “Insights gained in manufacturing and clinical development can be quickly shared across our global research, manufacturing and quality teams, a critical ability in our effort to deliver potentially transformative treatments to patients as fast as we can.”
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