Immix Biopharma, Inc., a clinical-stage biopharmaceutical company focused on advancing cell therapies for AL Amyloidosis and autoimmune conditions, has received an $8 million CLIN2 grant from the California Institute for Regenerative Medicine (CIRM). This funding will aid the clinical development of NXC-201, a chimeric antigen receptor T-cell (CAR-T) therapy, aimed at treating relapsed/refractory AL Amyloidosis.

Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM, emphasized the importance of this grant: “AL amyloidosis is a condition with significant unmet needs. Existing treatments are often poorly tolerated and fail to provide long-term relief. NXC-201 has shown promising preliminary results and could offer a novel therapeutic approach.”

Immix Biopharma’s CEO, Ilya Rachman, M.D., Ph.D., expressed appreciation for the grant, highlighting the need for new treatments for relapsed/refractory AL Amyloidosis. CFO Gabriel Morris added, “We are excited to contribute to California’s dynamic CIRM biotech community as we advance the NEXICART-2 study.”

The NEXICART-2 study (NCT06097832) is a U.S.-based Phase 1b/2 clinical trial assessing the safety and effectiveness of NXC-201 in patients with relapsed/refractory AL Amyloidosis who have preserved cardiac function and have not previously received BCMA-targeted therapy. The trial will enroll 40 patients and evaluate two initial doses (150 million and 450 million CAR+T cells), with the possibility of escalating to 800 million CAR+T cells based on initial findings. The study’s primary goals include assessing the complete response rate and overall response rate.

NEXICART-1 (NCT04720313) is an ex-U.S. Phase 1b/2a trial examining NXC-201 in patients with relapsed/refractory multiple myeloma and AL Amyloidosis. This trial aims to assess safety, efficacy, and determine the recommended Phase 2 dose. Initial results were presented at ASGCT 2024 and are available on Immix Biopharma’s website.

NXC-201 is a CAR-T therapy targeting BCMA, developed for relapsed/refractory AL Amyloidosis. Early results from NEXICART-1 indicate short-duration cytokine release syndrome (CRS) and no severe neurotoxicity. The therapy is part of a comprehensive development program and has received Orphan Drug Designation from the FDA and EMA.

AL amyloidosis is characterized by abnormal plasma cells that produce misfolded amyloid proteins, leading to their accumulation in vital organs such as the heart, kidneys, and liver. This condition results in progressive organ damage and high mortality. The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is projected to reach about 33,277 patients by 2024, with the amyloidosis market expected to grow to $6 billion by 2025.

 

Source: globenewswire.com

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