Nexcella, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, reported the successful completion of its second CAR-T NXC-201 engineering batch at its U.S. manufacturing site. This represents an important step forward in the planned U.S. expansion of the company’s ongoing Phase 1b/2a NEXICART-1 study of its novel BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201.

“The completion of our second U.S. engineering batch is a key step towards expanding our NXC-201 clinical trial to the U.S.,” said Ilya Rachman, executive chairman of Nexcella. “Not only is NXC-201 the first CAR-T in AL amyloidosis, in addition we believe NXC-201’s observed zero neurotoxicity and favorable tolerability profile across 58 patients to-date could enable expansion into earlier lines of therapy and out-patient NXC-201 dosing.”

“Today, CAR-T cell therapies generate greater than $3 billion of annualized sales, even though due to side effects, they are dosed in only 5% of U.S. hospitals,” said Gabriel Morris, president of Nexcella. “We believe NXC-201 will overcome the neurotoxicity and side effect barrier to expand CAR-Ts into to the remaining 95% of the market.”