Nexcella, Inc. Entered into an Agreement with a US Cell Therapy Manufacturer
Nexcella, Inc, a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications has announced that it has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will supply a US Phase 1b/2 clinical trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and AL amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.
Nexcella’s manufacturing partner will supply NXC-201 material for the Phase 1b/2 clinical trial in the U.S. following an IND submission to the FDA and approval. Over the coming months, Nexcella plans to initiate a pre-IND meeting with the FDA, submit an IND application to the FDA, and obtain IND approval for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.
President of Nexcella, Gabriel Morris has shared that they are excited about company’s progress toward bringing NXC-201 to US clinical sites. Securing clinical supply is a critical step in advancing NXC-201 toward a potential U.S. regulatory submission. The company believes that NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma.
About Nexcella, Inc.
Nexcella, Inc., is a subsidiary of Immix Biopharma, Inc and is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Its N-GENIUS platform can discover, develop, and manufacture cutting-edge cell therapies for patients in need.