Immix Biopharma Reports Positive Early Results From NEXICART-2 Trial Of NXC-201 In AL Amyloidosis

Immix Biopharma

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(RTTNews) - Immix Biopharma, Inc. (IMMX), a clinical-stage biopharmaceutical company, on Thursday, announced encouraging early results from the first four patients in its ongoing Phase 1b/2 NEXICART-2 U.S. trial of NXC-201 for the treatment of relapsed/refractory Light Chain (AL) Amyloidosis.

The NEXICART-2 trial is the only ongoing clinical trial of a CAR-T therapy in the U.S. for AL Amyloidosis.

The trial is designed to evaluate NXC-201 in relapsed/refractory patients with preserved heart function. The company believes these early results validate its approach and expects future complete responders.

The study demonstrated that all four patients who received NXC-201 normalized their disease markers within 30 days of treatment. Of these patients, two are already classified as complete responders (CR), while the other two are bone marrow minimal residual disease (MRD) negative.

The patients remain in response as of the data cutoff date of November 14, 2024. The results are especially significant considering that all patients had a median of 4 prior lines of failed therapy before receiving NXC-201.

Key findings include:

--- Two patients classified as complete responders, and two others show MRD negativity.

--- All patients showed normalization of their disease markers, including a reduction in free light chains (FLC) and M-spike.

--- No instances of immune effector cell-associated neurotoxicity syndrome (ICANS) or severe cytokine release syndrome (CRS) were observed. Grade 1 and 2 CRS were reported in two patients, which resolved with tocilizumab treatment.

--- The therapy was well-tolerated, with no major hematologic or treatment-related adverse events.

Immix Biopharma plans to continue enrolling patients in the trial and will provide an update in the first half of 2025.

Interim data is expected in the second quarter or third quarter of 2025, with final topline results anticipated in the second quarter or third quarter of 2026.

The company will host a conference call today, December 19, 2024, at 11:00 AM ET to discuss the topline data.

IMMX is currently trading at $2.21, up by 5.30%.