Immix Biopharma reported an 89% complete response rate in an interim update from its 45-patient NEXICART-2 clinical trial, providing a new data point for the company’s development of NXC-201 in relapsed/refractory AL amyloidosis. The company disclosed the results Sept. 29 in a Form 8-K filing with the U.S. Securities and Exchange Commission, accompanied by an investor presentation and press release.
Across all 45 patients enrolled in the Phase 2 study, 40 achieved a complete response, according to the company. The complete response rate was assessed by an independent review committee, making the 40-of-45 figure the central efficacy measure in the latest update. Immix said the study is fully enrolled and has a registrational design.
The update also covered 25 patients who were newly included in the latest analysis. All 25 were either in complete response or had reached minimum residual disease, with 21 patients in complete response and four MRD-negative. The company said all patients who have reached MRD-negativity to date subsequently achieved complete response within one year of treatment.
Four patients who remain classified as pending were already MRD-negative at the time of the update. Immix said those results could eventually bring the complete response rate to as high as 98%, or 44 of 45 patients, if the four patients later achieve complete response. That figure is a potential future outcome rather than a current trial result.
Immix also reported that no relapses had been observed to date among patients who had reached complete response or MRD-negativity. The company said no neurotoxicity or enterocolitis had been observed to date, while safety data through Aug. 4 remained generally consistent with previously reported NEXICART-2 safety findings.
NEXICART-2 is evaluating NXC-201, an investigational BCMA-targeted CAR-T therapy, in patients with relapsed or refractory AL amyloidosis. The disease is caused by abnormal plasma cells producing light chains that can accumulate in organs including the heart, kidneys and liver. NXC-201 has received Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations from the U.S. Food and Drug Administration, as well as Orphan Drug designations from U.S. and European regulators.
The latest results expand on Immix’s May update, when the company reported a 95% complete response rate among the first 20 patients, or 19 of 20. The September analysis covers more than twice that earlier patient population and therefore provides a broader interim view of the study, although it remains subject to the limitations of an interim clinical readout.
Immix said it plans to report the final NEXICART-2 results and submit a Biologics License Application for NXC-201 in mid-2027. Those plans are forward-looking and remain dependent on the final clinical data and regulatory process. NXC-201 has not been approved by the FDA or another regulatory authority.
