Immix Biopharma, Inc. (NASDAQ:IMMX) reported interim data from its NEXICART-2 Phase 2 clinical trial of NXC-201 in patients with relapsed or refractory AL amyloidosis.
According to the company, NXC-201 produced an 89% complete response rate across all 45 enrolled patients, based on an assessment by an independent review committee.
NXC-201 is an investigational CAR-T therapy being evaluated in the 45-patient, multi-site US Phase 2 study.
Newly Enrolled Patients Show Complete Response or MRD-Negativity
Immix Biopharma said all 25 newly enrolled patients had either achieved a complete response or were minimal residual disease, or MRD, negative.
Of those patients, 21 achieved a complete response, while the remaining four were MRD-negative and were awaiting complete response assessment.
The company said that, to date, all patients in the study who became MRD-negative subsequently achieved a complete response within one year of treatment.
Based on that observation, Immix said the four patients who are currently MRD-negative could subsequently reach complete response, which would increase the overall complete response rate to as much as 98%, or 44 of 45 patients.
The potential 98% rate is a company projection based on previous observations in the trial and is not a currently observed complete response rate.
Company Reports No Relapses Among Responders
Immix Biopharma said no relapses have been observed to date among patients who achieved either complete response or MRD-negativity.
The company also reported that no neurotoxicity or enterocolitis has been observed in the NEXICART-2 trial to date.
The interim findings remain subject to further follow-up, and the supplied information does not provide additional safety data or details regarding the duration of follow-up for individual patients.
FDA Submission Planned for Mid-2027
NXC-201 has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy designation from the US Food and Drug Administration.
The therapy has also received Orphan Drug Designation from both the FDA and the European Medicines Agency.
Immix Biopharma plans to report final NEXICART-2 data and submit a Biologics License Application to the FDA in mid-2027.
The NEXICART-2 study is registered under clinical trial identifier NCT06097832 and has what the company describes as a registrational design. The regulatory designations and planned BLA submission do not guarantee regulatory approval.
Immix Biopharma stock price
