Immix Biopharma (NASDAQ: IMMX) has reported interim data showing an 89% complete response (CR) rate across all 45 enrolled patients, based on an assessment by an independent review committee, from its NEXICART-2 Phase 2 clinical trial of NXC-201 in patients with relapsed or refractory (R/R) AL amyloidosis.
According to Immix, all 25 newly enrolled patients had either achieved a CR or were minimal residual disease, or MRD, negative. Of those patients, 21 achieved a CR, while the remaining four were MRD-negative and were awaiting complete response assessment.
NXC-201 has received Breakthrough Therapy Designation, Regenerative Medicine Advanced Therapy designation, and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation from the EMA.
The company plans to report final NEXICART-2 data and submit a Biologics License Application to the FDA in mid-2027.
