Takeda has decided to discontinue the development programs of its four oncology assets—Phase III asset modakafusp alfa (TAK-573) and three Phase I chimeric antigen receptor (CAR-T) assets: TAK-102, TAK-103 and TAK-940—as part of a plan to align its focus on advancing allogeneic cell therapies. Despite these adjustments, the Japan-based pharma major’s oncology pipeline remains robust, says GlobalData.
Takeda entered into multiple cell therapy collaborations for the development of CAR-T therapies with organisations like Memorial Sloan Kettering Cancer Center (MSK), Noile-Immune Biotech, and Crescendo Biologics in 2019 to advance the company’s novel immuno-oncology portfolio. Subsequently, the company had established a cell therapy manufacturing facility in the US.
Sasmitha Sahu, Pharma Analyst at GlobalData, comments, “It is interesting to note that Takeda has invested heavily in CAR-T therapies over the past five years but culled the CAR-T therapies out of the pipeline citing ‘strategic shift towards allogeneic cell therapies’. There is confirmation only from Noile-Immune Biotech about the termination of the collaboration, while the fate of other collaborations is still unknown. Takeda did not clarify if it will continue the development of another CAR-T therapy ADCLEC.syn1 for which it is listed as a collaborator in a Phase I trial by MSK.”
According to GlobalData Pharma Intelligence Center Drugs database, of the 10 marketed autologous CAR-T therapies, six of the globally approved therapies have been developed by US & EU-based multinational pharma companies, while the remaining four marketed therapies are from Chinese and Indian pharma companies approved in their respective countries. The CAR-T therapy pipeline is also dominated by Chinese pharma companies.
Sahu adds: “Many Asian pharma companies, particularly Chinese, are trying to tap into the therapeutic potential of CAR-T therapies. However, the USFDA had recently highlighted the risk of T-cell malignancies caused by these therapies. Although the number of autologous pipeline CAR-T therapies are more, an increasing trend is being observed in the number of early-phase allogenic candidates. Autologous CAR-T therapies take a very long time and patients may need bridging therapy until the CAR-T therapy cells are harvested and processed. Although Takeda did not specify, these could be some of the reasons behind its decision to discontinue the advancement of CAR-T therapies due to business viability.”
Takeda’s oncology pipeline now consists of one Phase III asset relugolix (TAK-385), three Phase II assets: subasumstat (TAK-981), TAK-007 and dazostinag (TAK-676) and four Phase I assets: TAK-500, TAK-186, TAK-280 and TAK-012.
Sahu concludes, “With five biologics and four small molecules aimed at multiple cancer indications, Takeda’s oncology pipeline appears well balanced. Notably, TAK-007 and TAK-012 are cell and gene therapies. Although the oncology pipeline is now devoid of any novel CAR-T therapies, it appears well diversified enough to help continue the company’s sustainability in oncology.”