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Immix Biopharma Subsidiary Nexcella Completes Pre-IND Meeting with FDA on NXC-201 US Clinical Trial
LOS ANGELES, June 26, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (“Nexcella”, “Company”, “We” or “Us”), a
About this update from Immix Biopharma, Inc.
[{"type":"text","content":"LOS ANGELES, June 26, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (“Nexcella”, “Company”, “We” or “Us”), a biopharmaceutical company pioneering cell therapies targeting oncology and other diseases, today announced it has completed a Pre-Investigational New Drug (“Pre-IND”) meeting with the FDA. The subject of the Pre-IND meeting was planned NXC-201 US manufacturing and US clinical trials in AL amyloidosis and multiple myeloma. “Completion of our planned Pre-IND meeting with FDA is an important milestone towards opening U.S. clinical trial sites for NXC-201,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We appreciate the FDA’s guidance and believe that with regulatory clarity in hand, our next step is to proceed with submitting a US IND application to the FDA for NXC-201.” A pre-IND meeting provides an opportunity for communication between a drug development company and the FDA to discuss an investigational new drug (IND) proposed filing and plan to obtain the agency’s guidance for the initial clinical studies of a novel drug candidate. The FDA reviewed the pre-IND package submitted by Nexcella including clinical data, manufacturing plan and the phase 1b/2 study protocol synopsis for NXC-201, provided guidance and recommendations, as well as addressed Nexcella’s questions on the development plan of NXC-201 in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. About NXC-201 NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. About NEXICART-1 NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractor...