NEWS Immix Biopharma Announces Complete Response in 9th Relapsed/Refractory AL Amyloidosis Patient in NXC-201 Clinical Trial at IMS 20th Annual Meeting
100% (9/9) overall response rate and 67% (6/9) complete response rate (MRD 10-5) observed in heavily pre-treated patients with daratumumab relapsed/refractory AL Amyloidosis as of the September 20, 2023 data cutoff
100% (4/4) overall response rate and 75% (3/4) complete response rate observed in t(11;14) relapsed/refractory AL Amyloidosis
Best responder duration of response was 19.2 months with response ongoing; median follow-up of 7.3 months (range: 2.5 – 16.5 months) as of the data cutoff date of September 20, 2023
ImmixBio plans to submit a BLA for FDA approval in AL Amyloidosis once 40 patients are treated with NXC-201
The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate
LOS ANGELES, Oct. 03, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), today announced presentation of additional AL Amyloidosis clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, at an oral presentation at the 20th International Myeloma Society Annual (IMS) Meeting being held in Athens, Greece on September 27-30 2023. One new patient and additional follow-up data from an additional 8 patients (9 total) are included in this update. All patients were DARZALEX ® (daratumumab) combination therapy relapsed/refractory and experienced a median of 6 earlier treatments that failed to stop worsening of disease (lines of therapy) prior to receiving NXC-201.
“There are no approved drugs for relapsed/refractory AL Amyloidosis,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. “NXC-201’s 100% response rate in relapsed/refractory AL amyloidosis patients, including t(11;14) and cardiac involved, indicates a potential broad mechanism of action. Additionally, as a one-time treatment, NXC-201 would present an attractive alternative to multi-drug combination, long-term daily or weekly regimens for relapsed/refractory AL amyloidosis patients.”
“Currently, AL Amyloidosis treatment involves repeat dosing and weekly distant travel to academic medical centers,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. “One-time treatment with NXC-201 could fill the void for relapsed/refractory AL Amyloidosis, where there are no therapies approved today, while restoring quality of life.”
Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “NXC-201’s uniquely favorable CAR-T tolerability profile and an apparent ability to clear disease-causing amyloid chains from the body within ~30 days could make it particularly suitable for treatment in a potential outpatient setting.”
