When Takeda unveiled its translational cell therapy engine early last year, the Japanese pharma made it clear the crew, under Novartis vet Stefan Wildt, is going all the way: clinical expertise, bioengineering chops, world-class collaborations, plus chemistry, manufacturing and control.
“In that early space, having it situated in proximity to our teams is quite powerful,” Chris Arendt, head of the oncology therapeutic area unit, told Endpoints News. “When you think about it, the process defines very much the medicine and the cell therapy space”
Designed to produce clinical-grade material from discovery through pivotal Phase IIb trials, the site will support five ongoing pacts. They include pluripotent stem cell work with Kyoto University Nobel laureate Shinya Yamanaka, gamma delta T cell research with Adrian Hayday and his biotech, armored CAR-Ts with Koji Tamada at Noile-Immune Biotech, next-gen CARs with Memorial Sloan Kettering’s Michel Sadelain, and finally CAR-NK with Katy Rezvani at MD Anderson.
With three programs now in the clinic, Takeda is now picking two more to test in humans in 2021, Arendt said. While each research partnership has taken on its own bespoke approach to manufacturing up to now, the new facility will provide a central spot to lock down the process development as close to the final product as possible.
At the forefront are TAK-007, an allogeneic CD19-targeted CAR-NK being tested in Phase I/II for relapsed or refractory non-Hodgkin’s lymphoma; TAK-940, 19(T2)28z1xx CAR-T cells featuring a next-gen signaling domain from MSK; and TAK-102, a cytokine and chemokine armored CAR-T directed at GPC3-expressing previously treated solid tumors. The latter two are in first-in-human trials.
Having a dedicated facility scales the operations up so that the team can simultaneously advance multiple programs, he added.
Before the Covid-19 pandemic sucked out all the oxygen in the room, the booming cell therapy market’s demand for physical infrastructure captured considerable attention. Gilead’s Kite constructed its own viral vector manufacturing center in order to leave “no stone unturned. Contract manufacturers like Catalent were snapping up space, and even Deerfield got into the game with a splashy, $1.1 billion entrance.
The way he’s built the team — now grown to well over 150 scientists — the learnings from any one program can be quickly applied to the whole portfolio, Wildt noted.
“We wanted to place the engine team at that sweet spot between late-stage discovery and rapidly putting forward innovative ideas and concepts into clinical translation,” he said. “It was just a concept a few years ago. And now we can partner with hospitals and patients and really see hopefully we can be successful on their behalf.”