Immix Biopharma announced advances in the NEXICART-2 clinical study of its CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, a plasma cell disorder that leads to progressive damage to the heart, kidney and liver, which currently affects approximately 33,000 patients in the U.S. Immix Biopharma’s sterically-optimized CAR-T NXC-201 is the only one-time CAR-T treatment option being studied for relapsed/refractory AL Amyloidosis in U.S. clinical trials.”We are pleased to report that the NEXICART-2 study is making excellent progress. We are now one step closer to providing a new treatment option for patients with relapsed/refractory AL Amyloidosis, where no FDA drugs are approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. “Robust enrollment reflects the enthusiasm of clinical investigators for CAR-T NXC-201.” “Positive data from our ex-US study of NXC-201, the largest CAR-T clinical study in relapsed/refractory AL Amyloidosis to-date, showed a 92% overall response rate and a 28.0 month duration of response, presented at ASGCT 2024,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma. The NEXICART-2 study is intended to evaluate the safety and efficacy of NXC-201 in relapsed/refractory AL Amyloidosis patients with adequate cardiac function who have not been exposed to prior BCMA-targeted therapy. Advancement to the second dosing cohort of three patients at 450 million CAR-T cells will dose one patient with NXC-201 every 28-days, subsequently enabling multiple patients to be dosed per month in NEXICART-2. Each of the NEXICART-2 dose levels have produced complete responses in relapsed/refractory AL Amyloidosis patients in the ex-U.S. NEXICART-1 study presented at ASGCT 2024.
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