Immix Biopharma(US:IMMX) Globenewswireยท2025-05-21 20:03Company 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 is NXC-201, a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy [12] - NXC-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Orphan Drug Designation (ODD) from both the FDA and EMA [9][12] Clinical Trials - The ongoing NEXICART-2 trial (NCT06097832) is a single-arm multi-site Phase 1/2 clinical trial evaluating NXC-201 in patients with relapsed/refractory AL Amyloidosis [8] - The trial aims to enroll 40 patients with preserved heart function and has safety as the primary endpoint for Phase 1 and efficacy for Phase 2 [8] - Initial data from the ex-U.S. study NEXICART-1 has shown high complete response rates in relapsed/refractory AL Amyloidosis [9] Market Insights - The U.S. prevalence of relapsed/refractory AL Amyloidosis is estimated to grow at 12% per year, reaching approximately 33,277 patients by 2024 [11] - The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025 [11] Key Opinion Leaders - A virtual KOL event is scheduled for June 3, 2025, featuring experts discussing interim clinical data from the NEXICART-2 trial [1][2] - Notable speakers include Dr. Heather Landau, Dr. Shahzad Raza, and Dr. Jeffrey Zonder, who will share their clinical experiences with NXC-201 [2][4][6][7]