Immix Biopharma(US:IMMX) Globenewswire·2025-12-07 23:15Core Insights - Immix Biopharma's NXC-201 demonstrated a complete response (CR) rate of 75% in a Phase 2 trial for relapsed/refractory AL Amyloidosis, with potential to increase to 95% based on MRD negativity predictions [1][3][4] - The company plans to submit a Biologics License Application (BLA) for NXC-201 in 2026 following the final readout of the NEXICART-2 trial [1][2] Clinical Results - In the Phase 2 trial, 15 out of 20 patients achieved a complete response, indicating significant efficacy [1][3] - Prior to treatment, patients had a median of 4 prior lines of therapy, and all had organ involvement due to AL Amyloidosis [3] - Clinical improvements were observed in 70% of evaluable patients, with no neurotoxicity reported [3] Market Context - Current treatments for relapsed/refractory AL Amyloidosis yield a CR rate of 10% or lower, highlighting a significant unmet medical need [4] - The U.S. patient population for relapsed/refractory AL Amyloidosis is projected to grow by 12% annually, reaching approximately 38,500 patients by 2026 [9] - The AL Amyloidosis market is expected to grow from $3.6 billion in 2017 to $6 billion by 2025 [9] Company Overview - Immix Biopharma is focused on developing NXC-201, a BCMA-targeted CAR-T cell therapy, which has received RMAT and Orphan Drug Designation from the FDA [7][10] - The ongoing NEXICART-2 trial is designed to enroll 40 patients and is pivotal for the company's future regulatory submissions [6][10]