Nexcella, Inc. announced 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 the company’s 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, M.D. PhD, 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.”
“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% of U.S. hospitals,” said Gabriel Morris, President of Nexcella. “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% of U.S. hospitals.”
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