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Immix Biopharma Subsidiary Nexcella Enters into U.S. GMP Manufacturing Agreement to Expand Ongoing NXC-201 Phase 1b/2 Clinical Trial to the U.S.
Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that
About this update from Immix Biopharma, Inc.
[{"type":"text","content":"Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that will supply Phase 1b/2 NXC-201 clinical trial materialNXC-201 is in development for the treatment of patients with relapsed or refractory multiple myeloma and light chain (AL) amyloidosis Nexcella believes recently reported Phase 1b data from the ongoing Phase 1b/2 clinical trial supports investigating NXC-201 as the first potential outpatient CAR-T cell therapy LOS ANGELES, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), today announced that it 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. As Nexcella plans to expand the ongoing Israel trial to the U.S., 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). This 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. Over the coming 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. We believe recently reported Phase 1b clinical data from the ongoing clinical trial in Israel supports expanding the NXC-201 trial to the U.S. As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed: Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion tr...