Sparks - Immix Biopharma

Immix Biopharma has confirmed it is going ahead with its preparations to explore additional indications with NXC-201, the company’s lead CAR-T candidate. NXC-201 has demonstrated highly favourable safety outcomes in clinical trials to date, with zero reported cases of neurotoxicity, offering potential advantages over currently approved CAR-T therapies.

As previously communicated, the NEXICART-2 trial is progressing swiftly, now with 18 active clinical trial sites. The NEXICART-2 trial is a US-based, open-label, single-arm, multi-site, dose-escalation and expansion Phase I/II trial. It is evaluating NXC-201 as a potential treatment for patients with relapsed/refractory amyloid light chain amyloidosis (r/r ALA). Management has said it is on track to submit a biologics license application once 40 r/r ALA patients have been treated (guided for mid-2026).

The latest clinical data readout was presented at ASCO 2025, corresponding to the first 10 patients treated in the trial. A complete response rate of 70% was reported, which was considered favourable, according to key opinion leaders (KOLs) in the corresponding KOL event.