On May 21, 2026 Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a global leader in AL Amyloidosis, reported that all four relapsed/refractory AL Amyloidosis MRD-negative patients presented at ASH (Free ASH Whitepaper) 2025 have converted to complete response (CR). The NEXICART-2 CR rate is now 95% (19 out of 20 patients). All CRs were reached within 1 year of follow-up post-dosing. No relapses have been observed as of today for patients who have reached CR. All subsequently enrolled patients for whom MRD results are available are MRD-negative at one month. The next NEXICART-2 update is expected late September 2026.
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These results support the Company’s plan to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL Amyloidosis patients.
"Even in a heavily pretreated population of median 4 prior lines of therapy, we are pleased that NXC-201, as a 5th line of therapy, drives MRD-negativity, converting to durable CRs to-date, indicating that NXC-201 can eliminate the source of toxic light chains that clog up the heart, kidney and liver, causing organ failure and death in relapsed/refractory AL Amyloidosis. As a potential frontline therapy in AL Amyloidosis, we believe there’s potential to transform a usual 2-year treatment, into a one-and-done: NXC-201." Gabriel Morris, President, Chief Financial Officer of Immix Biopharma, added, "We have observed the NEXICART-2 CR rate improving over time. In September 2026 we plan to present updated data from our ongoing NEXICART-2 trial. By end of March 2027, we expect to present 1-year follow-up data of enrolled patients, which we expect will drive BLA submission and commercial launch."
About NEXICART-2
NEXICART-2 (NCT06097832) is a multi-site U.S. Phase 2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis, with a registrational design. NEXICART-2 is a 45-patient study.
About AL Amyloidosis
AL amyloidosis is a devastating disease where the immune system, that’s supposed to protect, instead continuously produces toxic light chains, clogging up the heart, kidney and liver, causing organ failure and death.
The number of patients in the U.S. with relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 38,500 patients in 2026.
The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research as of 2023.
About NXC-201
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" that is designed to filter out non-specific activation. NXC-201 teaches the immune system to recognize and eliminate the source of the toxic light chains. NXC-201 has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA.
(Press release, Immix Biopharma, MAY 21, 2026, View Source [SID1234665931])