Nexcella Successfully Completes Manufacturing of NXC-201, the First Outpatient BCMA CAR-T for AL Amyloidosis with 100% ORR

NXC-201, as a BCMA CAR-T therapy, is used for the treatment of relapsed or refractory multiple myeloma (R/R MM) and AL amyloidosis.Its CAR structure has been optimized to ensure that NXC-201 features high transduction efficiency, high persistence, and low off-target rate., which can achieve better results at a lower dose, reducing toxicity caused by the dose. Meanwhile, the persistence of this candidate product has been enhanced, allowing it to function in the body for an extended period and reducing the occurrence of cell exhaustion.These features also support patients using them in outpatient settings..(The company has previously conducted preclinical evaluations and structural optimization verification of BCMA CAR, finding that the combination of the CD8 hinge region with the 4-1BB intracellular domain is more advantageous, but has not yet fully disclosed the design of this CAR).

In May 2023, the latest clinical data from the NEXICART-1 1b/2a phase trial of the NXC-201 therapy, presented at the 26th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT), showed:The objective response rate (ORR) was 100% and the complete response rate (CR) was 63% in 8 patients with AL amyloidosis.。And at the 49th Annual Meeting of the European Society for Blood and Marrow Transplantation held a month ago,Phase 1 Expansion Trial Data of NXC-201 in R/R MM Patients Shows ORR of 90% and CR of 59% in 42 Patients. Meanwhile, the drug tolerance is better.

Immix Biopharma CFO Gabriel Morris stated, "CAR-T cell therapy now generates over $3 billion in annual sales, despite side effects,Only 5% of hospitals in the United States use this therapy."But we believe that NXC-201 will overcome the obstacles of neurotoxicity and side effects, expanding CAR-T therapy to the remaining 95% of the market." At the same time, the leaders of Nexcella and Immix Biopharma both believeNXC-201 Has the Potential to Become the World's First Outpatient CAR-T Therapy。

CAR-T Therapy Has Been Gaining Attention, with Significant Progress in the CAR-T Field Over the Past Month.

• mmPACT Bio Announces First Patient Dosed in Phase 1/2 Clinical Trial of IMPT-314 for R/R Aggressive B-Cell Lymphoma. IMPT-314 is a potential First-in-class CAR-T product targeting CD19/CD20. Previously released data showed:IMPT-314 Achieves 91% ORR and 73% CR in 11 R/R Non-Hodgkin Lymphoma Patients, with a median progression-free survival of 18.2 months; the drug safety profile was favorable.

• PeproMene Bio Completes First Dose Cohort of PMB-CT01 in Phase 1 Clinical Trial for B-cell Non-Hodgkin Lymphoma (B-NHL), Plans to Initiate Second Dose CohortPMB-CT01 is the first autologous CAR-T cell therapy targeting BAFFR. Data from the first dose cohort showed: 100% ORR in 3 patients.(Two of them had previously received CD19 CAR-T therapy).

  
  

• Verismo Completes First Patient Dosing in Phase 1 Clinical Trial of SynKIR-110, a Dual-Chain CAR-T Cell Therapy Based on the KIR-CAR Technology Platform for the Treatment of Ovarian Cancer, Mesothelioma, and Cholangiocarcinoma Expressing Mesothelin. Its core technology originates from Carl June's team, the father of CAR-T.

• September 15,The IND applications for Immix Biopharma's "C-13-60 Cell Preparation" and "MC-1-50 Cell Preparation" have both been accepted.The former is a CEA-targeted CAR-T cell therapy developed by Precision Biologics based on the RESCAR and PHICAR platforms, which has previously been approved for clinical trials. The latter is a second-generation CD19-targeted CAR-T cell therapy independently developed by Precision Biologics based on the PRIMCAR platform. Data presented at the 2022 ASCO Annual Meeting showed:The ORR of its treatment for 13 patients with relapsed/refractory acute B lymphoblastic leukemia reached 100%.。

Whether it is the clinical data previously achieved by NXC-201 disclosed by Nexcella, Inc. this time, or the clinically validated data recently reported for other CAR-T therapies, all have demonstrated the therapeutic potential of CAR-T therapy in oncology and potentially more indications, which is highly encouraging. As CAR-T therapy progresses towards trends such as universal application, non-viral methods, in vivo administration, and broader indication expansion, it is foreseeable that the CAR-T field will become increasingly diverse in the future.

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