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Immix Biopharma Announces 95% Complete Response Rate in Interim Update From relapsed/refractory AL Amyloidosis Clinical Trial NEXICART-2

IMMX
  • Immix Biopharma announced that all four MRD-negative patients from the initial cohort have converted to complete response (CR) in the NEXICART-2 trial.
  • The overall CR rate for the trial has reached 95% (19 of 20 patients).
  • All patients achieving CR reached this status within 1 year of follow-up post-dosing with no relapses observed to-date.
  • All subsequently enrolled patients with available MRD results were MRD-negative at one month.
  • The company plans to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients based on these results.
  • The next NEXICART-2 data update is expected in late September 2026, with 1-year follow-up data anticipated by March 2027 to support a BLA submission.
  • NXC-201 is a sterically-optimized BCMA-targeted CAR-T cell therapy currently evaluated in the 45-patient NEXICART-2 Phase 2 study for relapsed/refractory AL Amyloidosis.
  • NXC-201 has received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy designation from the FDA, and Orphan Drug Designation from the FDA and EMA.
  • The U.S. relapsed/refractory AL Amyloidosis patient population is estimated to grow at 12% annually, reaching approximately 38,500 patients in 2026.