Immix Biopharma's NXC-201 Trial Achieves Primary Endpoint in AL Amyloidosis Treatment.

Immix Biopharma's NXC-201 trial has met its primary endpoint in AL Amyloidosis. The company is focused on developing CAR-T cell therapies for autoimmune diseases and multiple myeloma. Its lead asset, NXC-201, is being evaluated in a Phase Ib/IIa clinical trial, while its tissue-specific therapeutic IMX-110 is in clinical trials for solid tumors, including colorectal cancer and soft tissue sarcoma.

Immix Biopharma, Inc. has reported significant progress in its ongoing clinical trial for NXC-201, a cell therapy designed to treat AL Amyloidosis. The company announced today that NXC-201 met its primary endpoint with a complete response (CR) rate of 70% (7 out of 10 patients) in the U.S. multi-center NEXICART-2 Phase 1/2 clinical trial [1]. The trial, which evaluated NXC-201 in patients with relapsed/refractory AL Amyloidosis, showed no relapses or safety signals identified to date.

The interim results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Dr. Heather Landau of Memorial Sloan Kettering Cancer Center led the presentation. Immix Biopharma plans to submit a Biologics License Application (BLA) for FDA approval based on these promising results.

NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. The trial demonstrated high efficacy with all patients normalizing pathological disease markers and achieving either complete response or bone marrow minimum residual disease (MRD) negativity. The trial also showed downstream clinical improvements in cardiac and renal organ responses.

Immix Biopharma is a clinical-stage biopharmaceutical company focused on developing cell therapies for autoimmune diseases and multiple myeloma. The company's lead asset, NXC-201, is being evaluated in a Phase Ib/IIa clinical trial, while its tissue-specific therapeutic IMX-110 is in clinical trials for solid tumors, including colorectal cancer and soft tissue sarcoma.

A Key Opinion Leader (KOL) event to discuss the significance of the NXC-201 ASCO clinical data presentation will be held on Tuesday, June 3, 2025, at 3:00 pm ET. The event will feature lead investigators from Memorial Sloan Kettering Cancer Center, Cleveland Clinic, and Karmanos Cancer Center [2].

The Amyloidosis market was valued at $3.6 billion in 2017 and is expected to reach $6 billion in 2025, indicating a high unmet medical need for effective treatments [1].

References:
[1] Immix Biopharma Announces Primary Endpoint Met in Positive NXC-201 Interim Results Presented at ASCO [https://www.globenewswire.com/news-release/2025/06/03/3093133/0/en/Immix-Biopharma-Announces-Primary-Endpoint-Met-in-positive-NXC-201-Interim-Results-Presented-at-ASCO-Enabling-Path-to-Best-in-Class-Therapy-for-relapsed-refractory-AL-Amyloidosis.html]
[2] Immix Biopharma Announces Primary Endpoint Met in Positive NXC-201 Interim Results Presented at ASCO [https://www.marketscreener.com/quote/stock/IMMIX-BIOPHARMA-INC-130728145/news/Immix-Biopharma-Announces-Primary-Endpoint-Met-in-positive-NXC-201-Interim-Results-Presented-at-ASCO-50146149/]