Immix Biopharma is closer to dosing its first US patient for lead CAR-T asset NXC-201, with the appointment of the Memorial Sloan Kettering Cancer Center as the main clinical site for the company’s US multi-site NEXICART-2 trial assessing NXC-201 in relapsed/refractory (r/r) amyloid light chain amyloidosis (ALA). NXC-201 targets B-cell maturation antigen (BCMA) and is differentiated by its low neurotoxicity and short cytokine release syndrome (CRS) duration to date, supporting Immix’s long-term aspiration to launch the first outpatient CAR-T therapy. The NEXICART-2 study will aim to reproduce the initial results from the Phase Ib/IIa NEXICART-1 study, which reported an overall response rate (ORR) of 100% for the first 10 patients treated. Top-line data from the first 40 patients in the NEXICART-2 trial are expected in 2025, which, if positive, will likely be followed by a biologic license application, a significant milestone for the Immix. The pipeline remains engaged, with IMX-110 in Phase Ib/IIa studies for solid tumors and NXC-201 also targeting multiple myeloma (MM) and, potentially, other autoimmune indications (starting H124).
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