CARsgen's CAR-T therapy CT053 gains PRIME eligibility from EMA

China-based biotech CARsgen Therapeutics has been granted PRIority MEdicines (PRIME) eligibility to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell Maturation Antigen) autologous chimeric antigen receptor (CAR) T Cells (ct053) for the treatment of relapsed or refractory multiple myeloma, by the European Medicines Agency.

PRIME eligibility was based on clinical data from an ongoing CT053 BCMA CAR-T Phase I study in China. The results from the trial were presented at an oral presentation on September 14, 2019 in Boston at the 17th International Myeloma Workshop. As of June 30, 2019, 21 out of 24 myeloma patients (87.5%) who received a median of 4.5 prior lines of myeloma therapy showed objective response. 19 out of 24 patients (79.2%) achieved complete response. There was no grade 3 or higher cytokine release syndrome. The duration of response data will be reported at a future date.

"PRIME eligibility is an important regulatory milestone in the continued development and commercialization of CT053 anti-BCMA CAR T cells," said Dr Zonghai Li, chief executive of CARsgen, adding: "CT053 has demonstrated the potential to become the best-in-class BCMA CAR-T therapy. PRIME designation is invaluable to the advancement of this cutting-edge therapeutic to potential market approval and being available to patients as quickly as possible."