Nexcella, Inc., a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will supply a US Phase 1b/2 clinical trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.

“We are excited about our progress toward bringing NXC-201 to United States clinical sites,” said Gabriel Morris, president of Nexcella. “Securing clinical supply is a critical step in advancing NXC-201 toward a potential U.S. regulatory submission. We believe NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma.”

Ilya Rachman, executive chairman of Nexcella said: “NXC-201 has a highly differentiated, mild tolerability profile. We believe NXC-201 could be the world’s first outpatient CAR-T. We look forward to working with our partners at our new U.S. manufacturing site as we further our plans to bring NXC-201 to U.S. patients who need alternative treatments.”

With plans to expand the ongoing Israel trial to the U.S., Nexella says that it is necessary to demonstrate that clinical trial drug supply has been secured when submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA).

The U.S. manufacturing site is expected to supply NXC-201 material for the Phase 1b/2 clinical trial in the U.S. following an IND submission to the FDA and approval.

In the next few months, Nexcella plans to initiate a pre-IND meeting with the FDA, submit an IND application to the FDA, and obtain IND approval for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis.

The company believes recently reported Phase 1b clinical data from the ongoing clinical trial in Israel supports expanding the NXC-201 trial to the U.S.