Immix Biopharma is a clinical-stage biopharmaceutical company with a single lead drug candidate: NXC-201, a CAR-T cell therapy being developed to treat relapsed/refractory AL amyloidosis, a rare and life-threatening disease in which abnormal proteins accumulate in organs. There are currently no FDA-approved therapies for this indication, representing a significant unmet need. NXC-201 is an autologous CAR-T therapy — it uses the patient's own immune cells, modified to target BCMA, a protein expressed on the disease-causing plasma cells. Immix believes NXC-201 is the first autologous CAR-T in U.S. clinical trials specifically for AL amyloidosis. Immix is running two trials: NEXICART-2, a U.S. Phase 1b/2 registrational trial across 18 sites targeting 40 patients, and NEXICART-1, an ongoing ex-U.S. trial. Interim data from NEXICART-2 showed a 75% complete response rate in 20 patients, with organ responses in 70% of evaluable patients and a favorable safety profile. NXC-201 holds FDA Breakthrough Therapy and RMAT designations, both of which can expedite approval, as well as Orphan Drug designation providing 7 years of U.S. market exclusivity upon approval. Immix is pre-revenue and funds operations through equity issuances and grants. If approved, NXC-201 would be administered as a one-time treatment in specialized oncology centers. Immix in-licensed the core technology from Israeli research institutions and outsources manufacturing to third-party contract manufacturers.
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