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Immix Biopharma Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for NXC-201, sterically-optimized CAR-T for relapsed/refractory AL Amyloidosis
FDA RMAT designation follows positive proof-of-concept U.S. clinical data from the NXC-201 NEXICART-2 clinical trial in relapsed/refractory AL AmyloidosisRMAT
About this update from Immix Biopharma, Inc.
[{"type":"text","content":"FDA RMAT designation follows positive proof-of-concept U.S. clinical data from the NXC-201 NEXICART-2 clinical trial in relapsed/refractory AL AmyloidosisRMAT designation potentially streamlines the path to market approval by allowing frequent interactions with FDA and routes to FDA Accelerated Approval and Priority ReviewEnrollment in NEXICART-2 study accelerating; next update planned for H1 2025 LOS ANGELES,CA, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”, “IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL amyloidosis and select immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted RMAT designation to sterically-optimized CAR-T NXC-201 for the treatment of relapsed/refractory AL amyloidosis. As of June 2024 public information, FDA approved less than half of RMAT applications submitted to the agency during the last eight years. FDA RMAT designation requires that a drug is an advanced regenerative medicine, targets a serious condition, with the potential to treat, modify, reverse, or cure, and preliminary clinical evidence has indicated that the drug has the potential to address these unmet medical needs. “Receipt of FDA RMAT designation underscores the strength of our NXC-201 data and the potential for NXC-201 to provide a new treatment option for patients with relapsed/refractory AL amyloidosis, where no drugs are FDA approved today,” said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, “We are also pleased to report that the pace of enrollment in NEXICART-2 has accelerated, following successful completion of the safety run-in segment. We look forward to sharing further information on our progress, including an update on NEXICART-2, in the first half of 2025.” The RMAT designation is intended to accelerate the development and review of promising investigational products, including cell therapies. To qualify, a product must be designed to treat, modify, reverse, or cure a serious or life-threatening disease, with preliminary clinical evidence suggesting it can address unmet medical needs. The RMAT designation offers several key advantages, including early and frequent interactions with the FDA to dis...