Immix Biopharma Completes Engineering Batch of NXC-201 CAR-T Therapy for U.S. Clinical Trial Expansion
核心洞察
Immix Biopharma successfully completed its third engineering batch of NXC-201, a BCMA (搜索)-targeted CAR-T cell therapy, at its U.S. manufacturing site.
This milestone supports the planned expansion of the NEXICART-1 clinical trial (NCT04720313) to include U.S. patients.
NXC-201 has demonstrated a 100% overall response rate in relapsed/refractory AL Amyloidosis (搜索) patients in earlier studies, receiving FDA Orphan Drug Designation.
Immix Biopharma, Inc. has announced the completion of its third engineering batch of NXC-201, a BCMA (搜索)-targeted CAR-T cell therapy, at its U.S. manufacturing facility. This achievement is a critical step towards expanding the ongoing NEXICART-1 (NCT04720313) clinical trial to sites within the United States.
NXC-201 Manufacturing and Clinical Potential
NXC-201 is an autologous CAR-T therapy, meaning it is manufactured using a patient's own T cells. The therapy targets B-cell maturation antigen (BCMA (搜索)), a protein expressed on multiple myeloma (搜索) and AL amyloidosis (搜索) cells. According to Immix Biopharma, NXC-201 has demonstrated a 100% overall response rate across nine relapsed/refractory AL Amyloidosis patients. The FDA has granted Orphan Drug Designation to NXC-201 for both multiple myeloma and AL Amyloidosis.
Expansion of CAR-T Therapy Access
Gabriel Morris, Chief Financial Officer of Immix Biopharma, noted that current CAR-T cell therapies generate over $3 billion in annualized sales but are only administered in 5% of U.S. hospitals due to neurotoxicity and other side effects. Immix Biopharma believes NXC-201 could offer a treatment option for patients on waiting lists for CAR-T cell therapies and potentially become the first outpatient CAR-T therapy, expanding its availability to the remaining 95% of U.S. hospitals.
About Immix Biopharma
Immix Biopharma, Inc. (Nasdaq: IMMX) is focused on developing personalized therapies for oncology and immunology. Their lead CAR-T cell therapy asset, NXC-201, is currently in Phase 1b/2a clinical trials for relapsed/refractory AL Amyloidosis (搜索) and relapsed/refractory multiple myeloma (搜索). Data from the NEXICART-1 study (NCT04720313) showed response rates of 95% and 100% in multiple myeloma and AL amyloidosis patients, respectively, across 72 patients (data from July 17, 2023).