Immix Biopharma - 2023 recap with a preview of active year ahead

IMMX has shared a 12-month recap, capturing key clinical and regulatory events from 2023, setting the stage for an active 2024. Its lead CAR-T asset (NXC-201) is a B-cell maturation antigen (BCMA) targeting therapy for amyloid light chain amyloidosis (ALA) and multiple myeloma (MM). The latest clinical data (Phase Ib/IIa NEXICART-1 trial) showed an overall response rate (ORR) of 100% in ALA patients (n=10) and 90% in MM patients (n=50). On the regulatory front, NXC-201 received Orphan Drug designation (ODD) in February 2024 from the EMA for ALA, and in Q323 from the FDA for ALA and MM. The FDA also cleared Immix’s Investigational New Drug (IND) application in Q423, permitting NXC-201 dosing at US trial sites (NEXICART-2 trial for ALA patients). We believe this is an important development step for NXC-201, and we look forward to rolling data readouts after the start of NEXICART-2, most likely in H124.