Immix Biopharma (IMMX) Study result summary

Clinical efficacy and patient outcomes

• 44 out of 45 patients achieved normalized toxic light chains, with a 95% organ response rate and an 89% complete response rate, expected to rise to 98% as follow-up continues.

• All 25 new patients are either in complete response or minimal residual disease negative, showing consistency with prior data.

• Deep and rapid organ responses were observed: 100% cardiac and 92% renal, with effects seen within days post-dosing.

• Extended remissions have been observed, with some patients surpassing two years without relapse.

• Patients and clinicians report significant symptomatic improvement within days, including relief from pain and fatigue.

Safety and tolerability

• Median duration of cytokine release syndrome (CRS) is one day, with no high-grade CRS, neurotoxicity, or enterocolitis observed.

• Therapy is well-tolerated across all patients, with a safety profile superior to other CAR T therapies.

• The short CRS duration is particularly advantageous for patients with coexisting heart and kidney failure.

• Outpatient administration is anticipated as familiarity grows, with current follow-up typically one to two days.

Study design and regulatory plans

• The study enrolled 45 patients in a multi-site U.S. Phase 2 trial of NXC-201, a BCMA-targeted CAR-T cell therapy, with a registrational design.

• A randomized controlled trial against daratumumab CyBorD is planned, with a 260-patient design mirroring the ANDROMEDA study.

• The therapy has received RMAT, Breakthrough Therapy, and Orphan Drug designations, with ongoing FDA communications and a planned BLA submission after sufficient follow-up; final readout and BLA submission are planned for mid-2027.

• The confirmatory trial will allow for interim analysis based on complete response rates.

• NXC-201 uses a proprietary "digital filter" to reduce non-specific activation.