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Nexcella Starts NXC-201 Engineering Batches at U.S. CAR-T Manufacturing Site

Mark the first step in transferring existing CAR-T GMP manufacturing process to the U.S.

By: Anthony Vecchione

Nexcella, Inc., a subsidiary of Immix Biopharma, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, started CAR-T NXC-201 engineering batches at its U.S. manufacturing site. These U.S. engineering batches will support the planned U.S. expansion of the company’s ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (car-T) cell therapy NXC-201. 

The company said that this manufacturing milestone represents a crucial next step in transferring the company’s existing CAR-T GMP manufacturing process to the U.S. following the selection of a U.S. GMP manufacturer in February 2023.

“We are working tirelessly to bring NXC-201 to U.S. patients,” said Ilya Rachman, executive chairman of Nexcella. “NXC-201 is the first CAR-T being developed in AL Amyloidosis, and in Multiple Myeloma, patients face significant obstacles when seeking BCMA-targeted CAR-T treatments like NXC-201. We look forward to continuing to advance NXC-201 as we work to improve treatment outcomes for patients in the U.S. suffering from AL amyloidosis and multiple myeloma.”

Gabriel Morris, president of Nexella said, “Today, 95% of U.S. medical centers are unable to offer CAR-T cell therapy. NXC-201 has already been trialed in over 50 patients, demonstrating a 1–2-day median short side-effect duration, which offers potential to become the first out-patient CAR-T, potentially reducing hospitalization costs up to 80% and enabling dosing in 95% of U.S. medical centers today unable to offer CAR-T cell therapy.”

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