GlobeNewswire·Dec 7, 2025, 6:15 PM ET

At ASH 2025 Oral Presentation, Immix Biopharma Reports Positive Phase 2 NXC-201 Results, Advancing Toward BLA Submission as a Potentially First- and Best-in-Class Therapy for relapsed/refractory AL Amyloidosis

Immix Biopharma announced positive Phase 2 NXC-201 results presented at ASH 2025 by Heather Landau, MD.
The independent review committee observed a 75% complete response rate (15/20 patients) at the serum/urine immunofixation negative level.
MRD negativity in bone marrow predicts future complete response in four of five pending patients, potentially raising the CR rate to 95%.
70% of evaluable patients showed downstream clinical improvement including organ responses.
No neurotoxicity was observed, with only low-grade cytokine release syndrome reported with a median duration of 1 day.
All 20 patients had prior exposure to an anti-CD38 antibody & a proteasome inhibitor, with a median of 4 prior lines of therapy.
Current standard treatments typically yield a 10% or lower CR rate in relapsed/refractory AL Amyloidosis, highlighting the unmet medical need.
The NEXICART-2 trial is a registrational Phase 2 study expected to enroll 40 patients.
A KOL event discussing the results is scheduled for December 7, 2025.
Final readout for NEXICART-2 & a Biologics License Application submission are planned for 2026.
NXC-201 is a sterically-optimized BCMA-targeted CAR-T therapy with an FDA-awarded RMAT designation & ODD in the US & EU.