Immix Biopharma (IMMX) Study result summary

Clinical results

• In 45 NEXICART-2 patients, 40 achieved CR (89%); including four who were MRD-negative but not yet in CR, 44/45 were in CR or MRD-negative, with a projected 98% CR rate as patients convert.

• All 25 newly reported patients were in CR or MRD-negative: 21 in CR and four MRD-negative; their baseline characteristics matched those of the first 20 patients.

• Historically, all patients who reached MRD negativity later converted to CR; median time to conversion was ~2 months, with conversion taking up to 320 days. The four current MRD-negative patients not yet in CR had less than six months of follow-up.

• No relapses were observed among patients achieving CR or MRD-negativity to date.

Safety and organ responses

• Median CRS duration was one day; no high-grade CRS, neurotoxicity or enterocolitis was observed, and treatment was described as mild and well tolerated.

• Organ responses were 100% cardiac and 92% renal; responses were observed at 26 days post-dose for cardiac and 59 days for renal.

• Some patients had passed the two-year mark with ongoing responses.

Study design and therapy

• NEXICART-2 is a multi-site U.S. Phase 2 registrational study of NXC-201, a BCMA-targeted CAR-T therapy, in relapsed/refractory AL amyloidosis; 45 patients were enrolled.

• NXC-201 uses a proprietary “digital filter” to reduce non-specific activation and received Breakthrough Therapy, RMAT and Orphan Drug Designations.