Immix Biopharma’s Nexcella presents interim data from NEXICART-1 study

Nexcella announced updated clinical data from its ongoing Phase 1 NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis. The dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma and one new evaluable patient in AL. The new data are being presented during a poster presentation at the European Society for Blood and Marrow Transplantation and European Hematology Association 5th European CAR T-cell Meeting to be held in Rotterdam, Netherlands February 9-11, 2023. As of the data cutoff of October 23, 2022, 42 multiple myeloma patients were evaluable for efficacy and safety. These patients comprised the dose escalation cohorts for the first dose level, the second dose level, and a dose expansion cohort at the recommended Phase 2 dose of 800 million CAR+T cells. This dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma at the NXC-201 RP2D. The interim NXC-201 data demonstrate potentially meaningful efficacy and durable responses in relapsed or refractory patients who have a poor prognosis. Of the 42 evaluable patients across all dose levels with median follow-up of 146 days: 35 of 42 overall response rate was achieved per International Myeloma Working Group criteria; 21 of 42 patients achieved complete response or a stringent complete response; 34 of 42 patients achieved greater than very good partial response; 1 of 42 patients achieved a partial response;Improved outcomes were observed in the 29 relapsed or refractory multiple myeloma patients receiving the therapeutic dose of NXC-201: 90% ORR was achieved per International Myeloma Working Group criteria; 17 of 29 patients achieved CR or sCR; 25 of 29 patients achieved greater than VGPR; 1 of 29 patients achieved a PR; NXC-201 continues to be well-tolerated. Of the 42 evaluable patients: No cases of immune effector cell-associated neurotoxicity syndrome; Low-grade CRS duration of median 2 days was observed, with the vast majority of CRS events starting on the day of infusion