Immix Biopharma(US:IMMX) Globenewswireยท2025-05-22 20:02Core Insights - Immix Biopharma reported strong efficacy and favorable safety results for its NXC-201 therapy in the NEXICART-2 Phase 1/2 clinical trial for relapsed/refractory AL Amyloidosis, with a complete response (CR) rate of 71% [1][4][3] - The company has received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for NXC-201, indicating significant progress towards regulatory approval [3][9] - The upcoming ASCO presentation on June 3, 2025, will provide updated results and further analysis of the trial data [5][2] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and other serious diseases [12] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies [9][12] - The company aims to enroll 40 patients in the ongoing NEXICART-2 trial, which is designed to evaluate the safety and efficacy of NXC-201 [8] Clinical Trial Details - The NEXICART-2 trial is a U.S. multi-site, single-arm study assessing NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - Prior to treatment, patients had a median of 4 lines of therapy, and all had organ involvement due to the disease [4] - No relapses or significant safety signals have been reported to date, with only low-grade cytokine release syndrome observed [4][3] Market Context - The prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients in 2024 [11] - The AL Amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11]