Immix Biopharma is advancing its BCMA-targeted CAR-T cell therapy candidate, NXC-201, for relapsed/refractory AL amyloidosis (R/R ALA) and relapsed/refractory multiple myeloma (R/R MM). The company recently announced FDA clearance of its Investigational New Drug (IND) application for NXC-201, allowing for expanded clinical trials in the United States. This follows promising Phase 1/2a data demonstrating high overall response rates in both indications.
Clinical Efficacy in Amyloidosis and Multiple Myeloma
NXC-201 has been dosed in over 70 patients and has shown a 100% overall response rate (9/9) in heavily pre-treated R/R ALA patients. In R/R MM, the therapy achieved a 95% overall response rate in heavily pre-treated patients (36/38), with a median follow-up of 11.9 months. These results were observed in the NEXICART-1 (NCT04720313) study, an ongoing Phase 1b/2a open-label trial evaluating the safety and efficacy of NXC-201.
NEXICART-2 Trial Expansion
With the recent IND clearance, Immix Biopharma plans to expand studies of NXC-201 in R/R ALA to U.S. sites under the NEXICART-2 (NCT06097832) trial. According to Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma, multiple leading U.S. sites are planning to enroll patients in the coming months. This expansion is particularly significant given the lack of approved treatment options for relapsed/refractory AL Amyloidosis patients.
About AL Amyloidosis
AL amyloidosis is a rare systemic disorder resulting from plasma cell abnormalities in the bone marrow. These abnormal plasma cells produce misfolded amyloid proteins that accumulate in tissues, nerves, and organs, leading to progressive organ damage and high mortality rates. The estimated annual global incidence of AL Amyloidosis is approximately 15,000 patients.
NXC-201: A Potential Game-Changer
NXC-201 has received Orphan Drug Designation (ODD) from the FDA for both AL Amyloidosis and multiple myeloma. Immix Biopharma believes NXC-201 has the potential to be the world’s first “Single-Day CRS” CAR-T, potentially enabling faster patient recovery and discharge. The company is also exploring the expansion of NXC-201 into autoimmune indications such as systemic lupus erythematosus (SLE), myasthenia gravis (MG), and multiple sclerosis (MS).
Upcoming KOL Event
To discuss NXC-201 and its potential in treating R/R ALA, Immix Biopharma will host a virtual Key Opinion Leader (KOL) event on November 29, 2023. The event will feature Heather Landau, MD (Memorial Sloan-Kettering Cancer Center), Vaishali Sanchorawala, MD (Boston University School of Medicine), and Susan Bal, MD (University of Alabama at Birmingham), who will discuss the current treatment landscape and the NEXICART-1 study.
