Busy week for BCMA.
On Monday, the FDA granted Gilead/Kite a CATMA-recognized CAR-T therapy orphan drug. At the same time, at the myeloma 2018 meeting, Amgen also announced early clinical data on its TBMA-targeted BiTE drug AMG-420. Affected by the data, the shares of Bluebird Bio and Celgene fell on Monday.
In this clinical trial, 5 patients in the high-dose group showed strict complete response (sCR) and 4 patients were negative for MRD. In addition, four of the patients responded for more than 10 months. These patients had previously received multiple lines of treatment and failed. Tolerated after receiving the drug treatment.
Compared with the previously published data of Celgene/Bluebird’s CAR-T therapy bb2121, Amgen’s early data on this drug has certain advantages. Although bb2121 belongs to CAR-T therapy, it can also target BCMA, and the therapy has entered Phase III clinical research and will likely be the first to be marketed.
However, Amgen’s early data on AMG 420 is excellent, and unlike the high cost of CAR-T therapy and the need for individualized treatment, the clinical application of AMG420 is relatively simple and convenient, so this drug may be produced for Bluebird’s CAR-T therapy. Certain threats. On Monday, Anjin shares rose 4%, Bluebird fell 6%, and Celgene fell 1%.
Amgen’s drug AMG 420 is BiTE (bispecific T cell engagers), a bispecific antibody that simultaneously targets BCMA and T cell targets on B cells, allowing T cells to exert cytotoxic activity to kill B cells. .
CAR-T therapy generally requires first collecting the patient’s T cells, then modifying the T cells to express a chimeric antigen receptor that targets BCMA, and then returning the cells to the patient to identify them accordingly. Tumor cells are removed and cleared.
But BiTE is similar to traditional drugs and does not require highly individualized treatment like CAR-T. And Amgen also has a deep accumulation in the field of BiTE, the first BiTE drug Blincyto has been approved for marketing.
In addition to being threatened by BiTE, Celgene and Bluebird are also facing competition from Johnson & Johnson. The data of the CAR-T therapy targeting Nanjing BCMA is also very good. Competition in this area will be very intense in the future.