IMMX
Published on 07/14/2025 at 13:11
Clinical Stage Cell Therapy for AL Amyloidosis
and Other Serious Diseases
July 2025
Pioneering Cell Therapy in AL Amyloidosis and Other Serious Diseases
Sterically-optimized, proprietary
CAR-T construct from Immix
N-GENIUS platform
Immix N-GENIUS platform produced NXC-201
NXC-201 is our lead, sterically-optimized CAR-T with "digital filter" that reduces non-specific activation (enhancing tolerability)
NXC-201 CAR-T construct provides barrier to entry
Dedicated team for NXC-201 in AL Amyloidosis and other serious diseases
Ex-NCI/NIH scientists designed cell therapy for benign tolerability, being developed by Immix (licensed from Israel)
Senior regulatory team with multiple BLAs at Pfizer/BMS
Scientific advisors from Stanford, Memorial Sloan Kettering, Columbia, Tufts, UCLA
Experienced management and Board of Directors
Sizable AL Amyloidosis market
Relapsed/refractory AL Amyloidosis target market: 34,600 U.S. patient prevalence (multi billion $ value)
Established billing code establishes pricing floor for BCMA CAR-T at $425,000 per dose
No drugs currently FDA approved in relapsed/refractory AL Amyloidosis
NXC-201: The only CAR-T in development for AL amyloidosis
We believe NXC-201 high complete response rates to-date significantly improve treatment options for
relapsed/refractory AL Amyloidosis patients (compared to real-world 0-10% complete response rates in r/r AL)
ASCO oral presentation of interim results for NEXICART-2 Phase1/2 clinical trial with registrational design
Source:. E Lebel et al. Efficacy and Safety of Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) for the Treatment of Relapsed and Refractory AL Amyloidosis. Presentation. ASH 2024. M. Assayag, et al. Asherie N, et al. Development and manufacture of novel locally produced anti-BCMA CAR T cells for the treatment of relapsed/refractory multiple myeloma: results from a phase I clinical trial. Haematologica. 2023 Jul 1;108(7):1827-1839. doi: 10.3324/haematol.2022.281628. PMID: 36200421; PMCID: PMC10316256. Quock TP, et al. Epidemiology of AL amyloidosis: a real-world study using US claims data. Blood Adv. 2018 May 22;2(10):1046-1053. doi: 10.1182/bloodadvances.2018016402. PMID: 29748430. Bazarbachi AH et al. Timing and outcomes of second-line therapy in the era of daratumumab-based frontline therapy in AL amyloidosis. Am J Hematol. 2024 Nov;99(11):2225-2228. doi: 10.1002/ajh.27450. Epub 2024 Aug 3. PMID: 39096115. Zanwar S, et al. Treatment patterns for AL amyloidosis after frontline daratumumab, bortezomib, cyclophosphamide, and dexamethasone treatment failures. Leukemia 2024.
2Q25
3Q25
4Q25
1Q26
2Q26
3Q26
Significant Near-Term Milestones
Phase 1 interim readout
ASCO oral presentation
Additional academic trial sites added
Other
Trial enrollment completion
NXC-201 U.S. NEXICART-2
Trial with Registrational Design
Final readout
Secured rights to NXC-201, N-GENIUS platform
FDA Orphan Drug Designation (ODD) and Regenerative Medicine Advanced Therapy (RMAT) Designation Granted
Reported ex-U.S. NEXICART-1 AL Amyloidosis
data at ASGCT 2023, ASH 2023, ASGCT 2024,
NEXICART-2 U.S. AL Amyloidosis clinical trial first 6 patients dosed; first patient at Memorial Sloan Kettering Cancer Center (met guidance)
Planned BLA Submission
Reported first 4 patients U.S. NEXICART-2 AL
Amyloidosis clinical data 4Q 2024 (met guidance)
NXC-201
Initial Clinical Data
in Other Serious
Diseases
Reported first 10 patients U.S. NEXICART-2 AL Amyloidosis clinical data Q2 2025 at ASCO 2025
N-GENIUS Platform: Sterically-Optimized CAR-T construct "Digital Filter" reduces non-specific activation, leading to better tolerability
NXC-201 sterically-optimized CAR-T's "Digital Filter"….
N-GENIUS PLATFORM
…reduces non-specific activation
ALL BCMA CAR-TS ARE NOT CREATED EQUAL
CD8
Signaling Protein
COBRA Binder
CD8 Hinge
CD8
Transmembrane Protein
4-1BB
CD3ζγ
Delivers "Digital"
Intracellular Signaling
Reduces cytokine release
Sterically-optimized key construct modifications
Enhances Plasma Cell Binding
Ensures High Expression
NXC-201
CAR-T
Source: M. Assayag, et al. Academic BCMA-CART cells (HBI0101), a promising approach for the treatment of LC Amyloidosis. 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT). Late Breaking Oral Presentation. Baltimore, MD. May, 2024. Feucht, M. Sadelain, et al. Calibration of CAR activation potential directs alternative T cell fates and therapeutic potency. Nature Medicine. 2019 Jan;25(1):82-88. 5
doi: 10.1038/s41591-018-0290-5. Epub 2018 Dec 17. PMID: 30559421 PMCID: PMC6532069. O. Harush C. J. Cohen, et al. Preclinical evaluation and structural optimization of anti-BCMA CAR to target multiple myeloma. Haematologica. 2022 Oct 1;107(10):2395-2407. doi: 10.3324/haematol.2021.280169. PMID: 35354252 PMCID: PMC9521250. Adapted from PEGS 2021. Zanwar S, et al. Eyal Lebel et al., Efficacy and Safety of Anti-B-Cell Maturation Antigen Chimeric Antigen Receptor T-Cell for the Treatment of Relapsed and Refractory AL Amyloidosis. JCO. JCO-24-02252. DOI:10.1200/JCO-24-02252.
Disclaimer
Immix Biopharma Inc. published this content on July 14, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on July 14, 2025 at 17:10 UTC.