Nexcella Begins Production of CAR-T Cell Therapy Engineering Batches at US Manufacturing Site
The start of production of US engineering batches of NXC-201, a CAR-T cell therapy candidate in early clinical development, is the first step in transferring Nexcella’s existing manufacturing process to the United States.
Nexcella, a subsidiary of US-based Immix Biopharma and a clinical-stage biopharmaceutical company, announced on May 26, 2023 that it has begun producing engineering batches of NXC-201, its lead candidate and a chimeric antigen receptor T cell (CAR-T) therapy, at its US manufacturing site.
These engineering batches are intended to support the company’s planned expansion into the United States of an ongoing Phase Ib/IIa clinical study (NEXICART-1 [NCT04720313]) in adults with relapsed or refractory multiple myeloma and amyloid light chain (AL) amyloidosis. NXC-201 is a novel B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy. The commencement of these engineering batches represents a crucial next step in transferring Nexcella’s existing CAR-T good manufacturing practice manufacturing process to the US, according to a company press release.
“We are working tirelessly to bring NXC-201 to US patients,” said Ilya Rachman, executive chairman of Nexcella, in the press release. “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 [such as] NXC-201. We look forward to continuing to advance NXC-201 as we work to improve treatment outcomes for patients in the US suffering from AL amyloidosis and multiple myeloma.”
“Today, 95% of US medical centers are unable to offer CAR-T cell therapy,” said Gabriel Morris, president of Nexcella, in the release. “NXC-201 has already been trialed in over 50 patients, demonstrating a [one to two]-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 US medical centers today unable to offer CAR-T cell therapy.”
Source: Nexcella
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