245 0 Kommentare Immix Biopharma Announces Positive NXC-201 Relapsed/Refractory AL Amyloidosis Clinical Data in ASGCT 2024 Late Breaking Oral Presentation - Seite 2

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 were no immune effector cell-associated neurotoxicity syndrome (ICANS) events
Median cytokine release syndrome (CRS) duration was 2 days (range: 1-5):
- No grade 4 CRS events
- 2 experienced no CRS; 3 experienced grade 1 CRS; 6 Experienced grade 2 CRS; 2 experienced grade 3 CRS

The NXC-201 27^th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT) late-breaking oral presentation can be accessed on the ImmixBio corporate website at this link: https://immixbio.com/pipeline/#publications

ASGCT 2024 Presentation Details:

Title	“Academic BCMA-CART cells (HBI0101), a promising approach for the treatment of LC Amyloidosis”
Type	Late Breaking Oral Presentation
Oral Presentation Date/Time	Friday, May 10, 2024, 8:45 am – 9:00 am Eastern Time
Session Title	Late-Breaking Abstracts II
Location	Baltimore Convention Center, Baltimore, MD