Takeda Pharmaceutical Company (Takeda) has announced the expansion of its cell therapy manufacturing capabilities with the opening of a 24000 sqft R&D facility at its R&D headquarters in Boston, Massachusetts.
“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.
Takeda’s pipeline of immuno-oncology programs includes innovative cell therapies, immune engager platforms, innate immuno-modulation, novel-scaffold immune check point platforms and oncolytic viruses.
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
The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current GMP facility is designed to meet US, EU and Japanese regulatory requirements for cell therapy manufacturing to support clinical trials around the world.
It will advance Takeda's platforms and programs with collaborators including Nobel Laureate Shinya Yamanaka, MD, PhD, Kyoto University (induced pluripotent stem cells), Adrian Hayday, PhD, Gamma Delta Therapeutics (gamma delta T-cells) and Katy Rezvani, MD, PhD, The University of Texas MD Anderson Cancer Center (CAR-NK).
Takeda and MD Anderson are developing an 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).
“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, PhD, 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.”