- Japanese drugmaker Takeda has opened a new facility at its research headquarters in Cambridge, Massachusetts to manufacture cancer cell therapies, part of the company's rapid push into development of the complex treatments.
- The site, roughly half the size of a football field, will produce different types of cell therapies for use in clinical trials, from the earliest stages through to large mid-stage tests. Takeda, with several academic and biotech partners, is currently studying three experimental cell therapies in cancer patients and expects to soon advance two more into clinical testing.
- Takeda, one of the world's largest developers of rare disease drugs as a result of its acquisition of Shire, has made cell and gene therapies a focus of its research and development plans. But the company is starting from behind leaders in both fields, such as Novartis and Gilead.
Manufacturing is a critical step in cell therapy, which typically involves genetic engineering of human immune cells to better target tumors. More so than for other types of drugs, how cell therapies are produced determines how easily the treatments can be delivered to patients, as well as the therapeutic qualities of the product.
"The process defines what the medicine will become," said Chris Arendt, head of Takeda's cancer therapies unit, in an interview.
So far, Takeda has leaned on its collaborators, such as MD Anderson Cancer Center in Texas and Memorial Sloan Kettering in New York, for the initial work needed to advance cell therapies into clinical study. A treatment for leukemia and lymphoma from researchers at the former and a blood cancer therapy from the latter are now in Phase 1 testing.
But as development advances, Takeda needs to scale production to an industrialized process that can support larger clinical trials and prepare for future commercialization — work the new 24,000-square-foot facility will help Takeda accomplish.
The site is located at Takeda's global research and development headquarters in the biotech hotspot of Cambridge, meaning employees in manufacturing will work nearby the Japanese drugmaker's cancer researchers.
"The clinical and technical disciplines [in cell therapy] are deeply intertwined," said Stefan Wildt, head of Takeda's translational cell therapy team, in an interview.
Takeda emphasizes academic and biotech collaborations as a major component of its R&D strategy. In cell therapy, the company has assembled a web of partnerships in the U.S., U.K. and Japan to explore new ways of making and developing the treatments.
With MD Anderson, for instance, Takeda is developing a type of engineered cell therapy that uses immune cells known as natural killers, rather than the T cells employed by Novartis and Gilead in their approved CAR-T cell cancer treatments.
MD Anderson and Takeda believe the NK cells could be better used "off-the-shelf," rather that manufactured custom for each individual cancer patient. Early testing has suggested some of the side effects common to CAR-T therapy may not be as pronounced for NK cell treatment.
The MD Anderson-developed candidate is Takeda's most advanced, while the two other experimental cell therapies only recently entered human trials. Two more will be advanced into Phase 1 studies this fiscal year, but Arendt declined to specify what cancers they would target.