Immix Biopharma Expands U.S. Sites for Relapsed/Refractory AL Amyloidosis Trial NEXICART-2

Immix Biopharma, Inc., a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and immune-mediated diseases, has announced the expansion of its U.S. relapsed/refractory AL Amyloidosis clinical trial, named NEXICART-2, by adding three new clinical trial sites. The newly included sites are Cleveland Clinic, UC Davis, and Sutter Health, all esteemed institutions in the field of AL Amyloidosis research. The lead site for this trial remains Memorial Sloan Kettering Cancer Center (MSKCC).

CAR-T NXC-201, the investigational therapy being evaluated in the NEXICART-2 study, aims to treat patients with relapsed/refractory AL Amyloidosis who have not previously undergone BCMA-targeted therapy and possess adequate cardiac function. The trial seeks to confirm the positive outcomes observed in the initial ex-U.S. study, NEXICART-1, which was presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024). In the NEXICART-1 study, a 92% overall response rate was noted among the relapsed/refractory AL Amyloidosis patients, with the best responder showing a duration of response of 28.0 months as of May 10, 2024.

Dr. Ilya Rachman, CEO of Immix Biopharma, expressed pride in the national expansion of the NEXICART-2 clinical trial, emphasizing the importance of these new sites and principal investigators in advancing treatment options for patients. Gabriel Morris, CFO of Immix Biopharma, underscored the significance of these additional sites for supporting upcoming interim and final readouts of the trial.

NXC-201 stands out as the only CAR-T therapy in development for AL Amyloidosis, and was featured in a June 2024 review article, “Systemic Light Chain Amyloidosis,” in the New England Journal of Medicine. The NEXICART-2 trial (NCT06097832) is structured as an open-label, single-arm, multi-site U.S. Phase 1b/2 dose expansion study. It is designed to enroll 40 patients who meet the criteria of adequate cardiac function and no prior exposure to BCMA-targeted therapy. The initial phase of the study involves a safety-run in with two dosing levels (150 million CAR+T cells and 450 million CAR+T cells) involving three patients each, with the possibility of escalating to 800 million CAR+T cells. The primary endpoints for this trial are complete response rate and overall response rate based on consensus recommendations.

The ex-U.S. NEXICART-1 trial (NCT04720313) has already provided valuable data on the safety and efficacy of NXC-201 in patients with relapsed/refractory multiple myeloma and AL Amyloidosis, including those with impaired cardiac function and those previously exposed to BCMA-targeted therapy. NXC-201 has shown no neurotoxicity of any kind in AL Amyloidosis patients and has demonstrated a short duration of cytokine release syndrome (CRS).

NXC-201 has also been granted Orphan Drug Designation (ODD) by both the U.S. FDA and the European Medicines Agency (EMA) for AL Amyloidosis, highlighting its potential in treating this condition.

AL Amyloidosis is a progressive disease caused by abnormal plasma cells in the bone marrow that produce misfolded amyloid proteins. These proteins accumulate in vital organs, leading to serious damage and high mortality rates. The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is growing at an estimated rate of 12% per year, with approximately 33,277 patients expected in 2024. The amyloidosis market was valued at $3.6 billion in 2017 and is projected to reach $6 billion by 2025.

Immix Biopharma continues to focus on the development of cell therapies for AL Amyloidosis and broader immune-mediated diseases, with its lead candidate, NXC-201, at the forefront of its clinical programs.