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

All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024
Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as CRs in the coming weeks and months
Company to provide next program update in H1 2025
Conference call to discuss results Dec 19 at 11:00 a.m. ET (link to attend)

LOS ANGELES, CA, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced initial clinical data from the first four patients in the ongoing NEXICART-2 (NCT06097832) U.S. study of sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in relapsed/refractory AL Amyloidosis. Immix plans to host a conference call to review the results on Thursday, December 19, 2024 at 11:00 AM ET.

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 (excluding patients with pre-existing heart failure), who have progressed on Dara-CyBorD. NEXICART-2 builds on prior ex-U.S. study NEXICART-1. NEXICART-2 has completed the first dosing cohort and is currently dosing patients at the expansion cohort dose level. NEXICART-2 is the only ongoing clinical trial of a CAR-T in the United States for AL Amyloidosis. NEXICART-2 opened for enrollment June 2024 and this is the first clinical data being reported from the study.

“Today’s announcement represents a major step forward for Immix. We believe this first data cut of U.S. study NEXICART-2 including rapid and deep responses validates our strategy to focus on relapsed/refractory AL Amyloidosis patients with preserved heart function, who will benefit most from NXC-201 treatment,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We credit the resolute efforts of our investigators, sites, and team as we continue on track for NEXICART-2 interim and final read-outs.”

The results include follow-up and clinical data from four patients, and includes NX2-003 patient data through month three. Median follow-up is 85 days (range 29-141) as of the data cut-off date of November 14, 2024.

Patient Characteristics

All patients were relapsed (n=1) or refractory (n=3) to an anti-CD38 antibody and experienced a median of 4 prior lines of therapy (range: 2-6) that failed to stop worsening of disease prior to receiving NXC-201.
Two patients (50%) had received prior autologous stem cell transplant.

Disease Markers at enrollment

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 M-spike was 0.79 g/dL
Patients were cardiac Mayo stage I/II (two Stage II, two stage I) with median NT-proBNP 389 pg/mL (range: 146 – 1,297). Three patients had New York Heart Association (NYHA) class I heart failure while one had class II
One patient had kidney involvement with 3.0gm albuminuria in 24 hours

Clinical Results

Three patients received 150 million and 1 received 450 million CAR+T cells
Median follow-up was 85 days (range 29-141) as of the data cut-off date of November 14, 2024

Disease Markers after NXC-201 treatment

All four patients treated with NXC-201 normalized their disease markers within 30 days of dosing, of which, two are already classified as complete responders (CR), and the remaining two are bone marrow MRD negative (10-6); all patients remain in response as of the data cutoff of Nov 14, 2024
Bone marrow MRD negativity predicts future CR; company believes remaining two patients could be confirmed as CR in the coming weeks and months

- Patients NX2-001, NX2-002, and NX2-004 all had reduction of dFLC to