On April 23, 2025 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, reported that Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2025) being held in Chicago, Illinois, May 30 – June 3, 2025, presented by lead investigator Heather Landau, M.D., Director of Amyloidosis Program and a Bone Marrow Transplant Specialist & Cellular Therapist at Memorial Sloan-Kettering Cancer Center in New York (Press release, Immix Biopharma, APR 23, 2025, View Source [SID1234652055]).
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ASCO Presentation Details
Title "Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201"
Presentation
Date/Time (Central Daylight Time)
Session Date: Tuesday, June 3, 2025
Session Time: 9:45am – 12:45pm CDT
Presentation Abstract Number: 7508
Session Name: 652. Oral Abstract Session – Hematologic Malignancies-Plasma Cell Dyscrasia
Event details are available on the Immix website in the Presentation & Events section at View Source
About NEXICART-2
NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy.
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. Phase 1/2 U.S. study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.
About AL Amyloidosis
AL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates.
The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024.
The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research.