Nexcella, Inc., clinical-stage biopharmaceutical company, reported the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 at its U.S. manufacturing site.

NXC-201 will be manufactured for each individual patient using the patient’s own T cells at its state-of-the-art cellular immunotherapy manufacturing facility in California.

“We believe the completion of our 3rd U.S. engineering batch represents an important threshold to demonstrate our U.S. manufacturing capability for NXC-201 IND submission in the United States,” said Ilya Rachman, executive chairman of Nexcella. “NXC-201’s 100% observed overall response rate across 9 relapsed/refractory AL Amyloidosis patients, where NXC-201 has received orphan drug designation from the FDA, makes this an important milestone in bringing NXC-201 to U.S. patients.”

Gabriel Morris, president of Nexcella said, “Today, CAR-T cell therapies generate greater than $3 billion of annualized sales, even though due to neurotoxicity and side effects, they are dosed in only 5 percent of U.S. hospitals. NXC-201 has been dosed in a large number of patients across released/refractory AL amyloidosis and relapsed/refractory multiple myeloma. We believe NXC-201 could offer hope to those on waiting lists for CAR-T cell therapies, and potentially become the first out-patient CAR-T expanding into to the remaining 95 percent of U.S. hospitals.”