NXC-201 Platform and Clinical Trial - NXC-201 is a sterically-optimized CAR-T construct from the Immix N-GENIUS platform with a "digital filter" to reduce non-specific activation and enhance tolerability[6] - The company plans to submit a BLA for NXC-201[9] - The NEXICART-2 trial is a U S multi-center trial with registrational design for relapsed/refractory AL Amyloidosis with 40 patients enrolled[6,39] - Interim clinical data readout for the NEXICART-2 trial in relapsed/refractory AL Amyloidosis is expected in 2Q 2025[35] - Planned NEXICART-2 enrollment completion is expected in 4Q 2025 / 1Q 2026[35] AL Amyloidosis Market and NXC-201 Potential - The relapsed/refractory AL Amyloidosis target market has a U S patient prevalence of 34,600, representing a multi-billion dollar value[6] - There are currently no FDA-approved drugs for relapsed/refractory AL Amyloidosis[6,27] - Current standards of care induce a complete response in 0-10% of patients with relapsed/refractory AL Amyloidosis[19,21,27] - In the NEXICART-2 U S trial, 70% complete responses (CR) were observed in 7 out of 10 patients, with the remaining three being MRD-negative 10-6, predicting future CR[49] NXC-201 Safety and Tolerability - NXC-201 demonstrated no ICANS neurotoxicity in clinical trials[54] - NXC-201 has a median CRS duration of 1 day, which is 4-8x shorter than other CAR-T therapies[32]
Immix Biopharma (IMMX) Earnings Call Presentation