IMMX - Immix Biopharma Announces Positive NXC-201 Relapsed/Refractory AL Amyloidosis Clinical Data in ASGCT 2024 Late Breaking Oral Presentation | Benzinga

92% (12/13) overall response rate (ORR) for relapsed/refractory AL Amyloidosis patients enrolled in NEXICART-1:

• 12 out of 12 patients not exposed to prior BCMA-targeted bispecific responded to NXC-201 (100% ORR), of which 9 out of 12 were complete responders (75% CRs)

• 1 patient with prior exposure to BCMA-targeted bispecific treatment did not respond

• Best responder duration of response was 28.0 months with response ongoing as of May 10, 2024
  
• U.S. prevalence of relapsed/refractory AL Amyloidosis is growing 12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 33,277 patients in 2024
  

LOS ANGELES, May 10, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ("ImmixBio", "Company", "We" or "Us" or "IMMX"), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) in a late breaking oral presentation at the 27^th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT) in Baltimore, MD. All patients were relapsed/refractory to standards-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone).

"Relapsed/refractory AL Amyloidosis remains an unmet medical need, with no approved options for treatment," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization's Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NEXICART-1 principal study investigator. "We continue to be encouraged by NXC-201's response rates and durable effect in patients without significant pre-existing cardiac damage, exemplified by our 28-month longest responder with response ongoing."

"We are excited to present clinical data from the NEXICART-1 clinical study at ASGCT. This study has informed the design of NEXICART-2 clinical trial, expected to open in the U.S. mid-2024," said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added: "We believe NXC-201's tolerability profile, including lack of neurotoxicity, makes it uniquely suitable as a potential new treatment option for relapsed/refractory AL Amyloidosis patients."

At the NXC-201 ASGCT 2024 late-breaking oral presentation, data were presented from 13 relapsed/refractory AL amyloidosis patients (including 3 new patients) in the ongoing Phase 1b/2a NEXICART-1 study. Patients were infused with CAR+T cells at doses of 150 x 10⁶ (n=1), 450 x 10⁶ (n=2), and 800 x 10⁶ (n=10).

Patient characteristics:

• 85% (11/13) had cardiac involvement
• 38% (5/13) had New York Heart Association (NYHA) stage 3 or 4 heart failure
• 38% (5/13) had Mayo stage 3 AL amyloidosis disease
• Relapsed/refractory to a median 4 lines of prior therapy (range: 3-10)
• 1 patient, patient 11, was treated and progressed on a BCMA-targeted bispecific antibody before NXC-201 treatment
  

Safety and efficacy data:

• Overall response rate (ORR) of 92% (12/13) for relapsed/refractory AL Amyloidosis patients enrolled in NEXICART-1:
  
  • 12 out of 12 patients not exposed to prior BCMA-targeted bispecific responded to NXC-201 (100% ORR), of which 9 out of 12 were complete responders (75% CRs)
  • 1 patient with prior exposure to BCMA-targeted bispecific treatment did not respond
• Best responder had a duration of response of 28.0 months as of May 10, 2024, with response ongoing
• There ...

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