Clinical Trial Results - All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, with two classified as complete responders (CR) and the remaining two achieving bone marrow MRD negativity [1][5] - Bone marrow MRD negativity predicts future CR, and the company believes the remaining two patients could be confirmed as CRs in the coming weeks and months [1][5] - Median follow-up was 85 days (range 29-141) as of the data cut-off date of November 14, 2024 [2][4] - Patients NX2-001, NX2-002, and NX2-004 had reduction of dFLC to <1 mg/dL, with MRD negativity in bone marrow by flow cytometry [5] - Patient NX2-003 had resolution of M-spike 15 days following NXC-201 treatment [5] - Improvement in NYHA class from class II to class I occurred in one patient 14 days following NXC-201 treatment [5] Patient Characteristics - All patients were relapsed (n=1) or refractory (n=3) to an anti-CD38 antibody and had a median of 4 prior lines of therapy (range: 2-6) [3] - Two patients (50%) had received prior autologous stem cell transplant [3] - At enrollment, median difference in free light chain (dFLC) was 65 mg/L (range: 24-86) among Patients NX2-001, NX2-002, and NX2-004, and Patient NX2-003 had an M-spike of 0.79 g/dL [3] - Patients were cardiac Mayo stage I/II with median NT-proBNP 389 pg/mL (range: 146-1,297) [3] - Three patients had NYHA class I heart failure, while one had class II [3] - One patient had kidney involvement with 3.0gm albuminuria in 24 hours [3] Tolerability and Safety - No patient developed immune effector cell-associated neurotoxicity syndrome [5] - No cytokine-release syndrome (CRS) was observed in two patients, while Grade 1 (n=1) and Grade 2 (n=1) CRS was observed in the other two patients, both lasting less than 24 hours following one dose of tocilizumab [5] - Hematologic adverse events included neutropenia in all four patients (three grade 3, one grade 4) [5] - No febrile neutropenia, treatment-related infections, cardiac toxicity, or deaths were reported [5] Next Steps and Program Updates - The company plans to continue enrolling patients in its potentially pivotal NEXICART-2 U.S. clinical trial for relapsed/refractory AL Amyloidosis [6] - The next program update is expected in H1 2025 [1][6] - Interim clinical data readout is expected in Q2/Q3 2025, with final topline clinical data readout expected in Q2/Q3 2026 [6] About NEXICART-2 and NXC-201 - NEXICART-2 is a Phase 1b/2, multi-site U.S. open-label dose escalation and dose expansion trial enrolling relapsed/refractory AL Amyloidosis patients with preserved heart function [1][7] - NXC-201 is a sterically-optimized BCMA-targeted CAR-T cell therapy, with initial data from Phase 1b/2 ex-U.S. study NEXICART-1 demonstrating high complete response rates and no neurotoxicity [8] - NXC-201 has been awarded Orphan Drug Designation (ODD) in AL Amyloidosis by the US FDA and in the EU by the EMA [8][9] Market and Industry Context - AL Amyloidosis is caused by abnormal plasma cells producing misfolded amyloid proteins, leading to organ damage and high mortality rates [9] - The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year, reaching approximately 33,277 patients in 2024 [9] - The Amyloidosis market was 6 billion in 2025 [9] Virtual Investor Event - The company will host a virtual investor event on Dec 19 at 11:00 a.m. ET to discuss the results [1][7]
Immix Biopharma Announces Positive U.S. Clinical Data From First Four Patients in NEXICART-2 U.S. Trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory Light Chain (AL) Amyloidosis