Takeda Expands Cell Therapy Efforts with New R&D Manufacturing Plant in Boston
It will provide end-to-end R&D capabilities and advance the company’s plans to develop next-generation cell therapies. The initial plan is to focus on oncology then expand into other 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, Head of Takeda’s Oncology Therapeutic Area.
He went on to say, “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.”
The facility will manufacture cell therapies all the way up to pivotal Phase IIb trials. Its current Good Manufacturing Practices (cGMP) facility meets all U.S., European Union and Japanese regulatory requirements for cell therapy manufacturing that can be used for Takeda clinical trials globally.
Takeda and MD Anderson are testing a possible best-in-class allogeneic cell therapy, TAK-007, a CD19-targeted CAR-NK cell therapy for off-the shelf use in patients with r/r non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It is currently in Phase I/II trials. Two more Phase I trials of the company’s cell therapies were recently launched, including 19(T2)28z1xx CAR T-cells (TAK-940), a next-generation CAR-T signaling domain developed with MD Anderson Sloan Kettering Cancer Center for r/r B-cell cancer and a cytokine and chemokine armored CAR-T (TAK-102). TAK-102 was developed with Noile-Immune Biotech to treat GPC3-expressing previously treated tumors.
Late last week, Takeda released data from the Phase III TOURMALINE-MM2 trial of Ninlaro (ixazomib) to lenalidomide and dexamethasone compared to lenalidomide and dexamethasone plus placebo in treating newly diagnosed multiple myeloma patients who were not eligible for autologous stem cell transplant. The trial did not meet statistical significance for the primary endpoint of progression-free survival (PFS).
The addition of Ninlaro resulted in a 13.5 month increase in median PFS, 35.3 months in the Ninlaro arm compared to 21.8 months in the placebo arm, but although there was a numerical improvement, it did not hit the threshold for statistical significance.
“There is a specific need in newly diagnosed multiple myeloma, given there are currently no approved all-oral, proteasome inhibitor-based treatment options,” said Thierry Facon, Lille University Hospital, principal investigator and lead author of TOURMALINE-MM2.
Facon added, “Findings from the TOURMALINE-MM2 trial are important overall for this patient population as well as across multiple subgroups including patients with high-risk cytogenetics. We hope these data will help inform future research and further progress for the multiple myeloma community.”
Ninlaro is an oral proteasome inhibitor. It is being evaluated across a broad range of MM treatment settings. It was first approved by the U.S. Food and Drug Administration (FDA) in November 2015 and is indicated in combination with lenalidomide and dexamethasone for patients with MM who have received at least one previous therapy. It is currently approved in more than 65 countries.
Earlier, Takeda indicated it had entered an agreement to sell some noncore prescription drugs that are sold primarily in Europe and Canada to Germany’s Cheplapharm for $562 million. Last month the company sold off a big chunk of its consumer health products to Blackstone Group for $2.3 billion. The company has a goal of divesting $10 billion.
Takeda’s five key focus areas are gastroenterology, rare diseases, oncology, plasma-derived therapies and neuroscience. It has $59 billion in debt from acquiring Shire and is selling off noncore areas to help pay down that debt.