Immix Biopharma announces FDA approval of IND application for NXC-201

Immix Biopharma announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for BCMA CAR-T NXC-201. With this clearance, NEXICART-2 is to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States. Favorable tolerability enables potential expansion into autoimmune indications. 72 patients have been dosed with NXC-201 ex-U.S. Relapsed/refractory AL Amyloidosis dose escalation levels included: 150 x 106, 450 x 106, and 800 x 106 CAR+T cells, demonstrating a 100% overall response rate. Relapsed/refractory multiple myeloma dose escalation levels included: 150 x 106, 450 x 106, and 800 x 106 CAR+T cells, demonstrating a 95% overall response rate with median 11.9 months of follow-up. NXC-201 publications, presentations and posters include the 65th American Society of Hematology Annual Meeting & Exposition, 27th Annual American Society for Gene and Cell Therapy, 20th International Myeloma Society Annual Meeting, Clinical Cancer Research, 49th Annual Meeting of the European Society for Blood and Marrow Transplantation and Haematologica.