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Immix Biopharma Accelerates Enrollment in U.S. AL Amyloidosis Trial of NXC-201 CAR-T
Successfully dosed 6 patients in safety run-in segment, now accelerating enrollmentPositive data from first four patients announced December 2024NXC-201 is
About this update from Immix Biopharma, Inc.
[{"type":"text","content":"Successfully dosed 6 patients in safety run-in segment, now accelerating enrollmentPositive data from first four patients announced December 2024NXC-201 is the only one-time CAR-T therapy in development for AL AmyloidosisNext program update Q1 2025 AL Amyloidosis is a life-threatening disorder of plasma cells in the bone marrow affecting ~33,000 patients in the U.S. LOS ANGELES, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and select immune-mediated diseases, today announced successful completion of the six-patient Phase 1b safety run-in segment in the U.S. NEXICART-2 study of NXC-201, an investigational CAR-T therapy, in patients relapsed/refractory (R/R) AL Amyloidosis. Achievement of this milestone is expected to accelerate enrollment across U.S. study sites beginning in January 2025. NEXICART-2 is an open-label study designed to evaluate NXC-201 in patients with R/R AL Amyloidosis. The study has two segments: a six-patient “safety run-in” segment and a 34-patient dose expansion segment. The Phase 1b “safety run-in” segment dosed three patients at 150 million CAR-T cells and three patients at 450 million CAR-T cells (these doses also produced complete responses in the prior ex-US NEXICART-1 study). All six patients successfully completed a post-dosing safety evaluation, and enrollment can now proceed across U.S. study sites at 450 million CAR-T cells. “We are pleased to report the successful completion of the NEXICART-2 safety run-in segment. Achievement of this milestone positions us to accelerate enrollment in the NEXICART-2 study and brings us one step closer to providing a new treatment option for patients with relapsed/refractory AL Amyloidosis, where no drugs are currently FDA approved,” said Ilya Rachman, MD, PhD, 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 with robust enrollment in our multi-site U.S. NEXICART-2 study. We are on track for the next program update in Q1 2025.” NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis, mentioned in a review article entitled “Systemic Light Chain...