Immix Biopharma Announces 100% Overall Response Rate (n=10); 23.7 months Best Response Duration (ongoing) for CAR-T NXC-201 in Relapsed/Refractory AL Amyloidosis Patients at ASH 2023
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100% (10/10) overall response rate (ORR) and70% (7/10) complete response (CR) rate observed in standard of care (Dara-CyBorD) relapsed/refractory AL Amyloidosis patients with median 6 lines of prior therapy in updated Phase 1/2 data as of December 10, 2023- Best responder duration of response was 23.7 months with response ongoing as of December 10, 2023
- U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing
12% per year according to Staron, et al Blood Cancer Journal, estimated to reach 29,712 patients in 2023
LOS ANGELES, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced new clinical data from its Phase 1b/2a NEXICART-1 (NCT04720313) study of novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis (R/R ALA) at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology (ASH) Meeting being held in San Diego, CA. The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD (daratumumab combined with cyclophosphamide, bortezomib, and dexamethasone) and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201.
“There is a rising prevalence of relapsed/refractory AL Amyloidosis patients who have 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 principal study investigator. “We continue to be encouraged by NXC-201’s
“We believe NXC-201 is the first and only CAR-T in clinical development for AL amyloidosis. With our recent IND clearance, we are thrilled to be now activating sites to bring this first-of-a-kind study to U.S. relapsed/refractory AL Amyloidosis patients,” 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 favorable tolerability profile, including ‘Single Day CRS’ and the ability to overcome neurotoxicity, enables a new potential option for relapsed/refractory AL Amyloidosis patients and potential expansion into select autoimmune indications.”
Immix Biopharma Announces
Immix Biopharma, Inc. (Nasdaq:IMMX)
At the NXC-201 ASH 2023 oral presentation, data were presented from 10 relapsed/refractory AL amyloidosis patients (including one new patient) in the ongoing Phase 1b/2a NEXICART-1 study, with median 6 lines of therapy prior to NXC-201. 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=7).
Patient characteristics:
90% (9/10) had high-risk cytogenetics80% (8/10) had cardiac involvement50% (5/10) had New York Heart Association (NYHA) stage 3 or 4 heart failure (3 stage 4, 2 stage 3)40% (4/10) had Mayo stage 3 (1 stage 3b, 3 stage 3a) AL amyloidosis disease40% (4/10) had t(11;14) translocation- Relapsed/refractory to a median 6 lines of prior therapy (range: 3-10)
Safety and efficacy data:
- Overall response rate of
100% (10/10) - Complete response + very good partial response rate of
90% (9/10) - Complete response rate of
70% (7/10) (6 out of 7 were MRD 10-5) - Organ response rate of
60% (6/10) - Best responder had a duration of response of 23.7 months as of December 10, 2023, with response ongoing
- Transformation to complete response at month 2 observed in a patient with 7 lines of prior therapy and cardiac involvement
- There were no immune effector cell-associated neurotoxicity syndrome (ICANS) events
- “Single Day CRS”: Median CRS duration was 1 day (range: 1-4):
- No grade 4 cytokine release syndrome (CRS) events
- 2 experienced no CRS; 2 experienced grade 1 CRS; 4 Experienced grade 2 CRS; 2 experienced grade 3 CRS
For the 8 patients with cardiac involvement:
- Overall response rate of
100% (8/8) - Complete response rate of
63% (5/8) (4 out of 5 were MRD 10-5) - Organ response rate of
63% (5/8)
For the 4 patients with t(11;14) disease:
- Overall response rate of
100% (4/4) - Complete response rate of
75% (3/4) (MRD 10-5) - Organ response rate of
50% (2/4)
The NXC-201 65th American Society of Hematology Meeting oral presentation video can be accessed on the ASH website: https://annualmeeting.hematology.org/session/227510
The NXC-201 65th American Society of Hematology Meeting oral presentation can be accessed on the ImmixBio corporate website at this link: https://immixbio.com/pipeline/#publications
ASH Presentation Details:
| Title | “Feasibility of a Novel Academic Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory AL Amyloidosis” |
| Presentation Date/Time (Pacific Time) |
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| Presentation Replay |
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About NXC-201
NXC-201 (formerly HBI0101) is a BCMA-targeted investigational chimeric antigen receptor T (CAR-T) cell therapy that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed/refractory AL amyloidosis, relapsed/refractory multiple myeloma, with potential expansion into autoimmune indications.
NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma.
About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the recommended Phase 2 dose (RP2D) of NXC-201. The Phase 1b portion has been successfully completed, with a recommended Phase 2 dose (RP2D) of 800 million CAR+T cells.
- The expected primary endpoint for NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate. ImmixBio plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients are treated with NXC-201.
- The expected primary endpoint for the Phase 2 portion in relapsed/refractory multiple myeloma is overall response rate and duration of response. ImmixBio plans to submit data to the FDA in relapsed/refractory multiple myeloma once 100 patients are treated with NXC-201.
About AL Amyloidosis
U.S. observed prevalence of relapsed/refractory AL Amyloidosis is growing
The Amyloidosis market was
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology with more than 100 patients treated to-date. Our lead cell therapy asset is the CAR-T NXC-201 for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma, for which we have observed overall response rates of
Forward Looking Statements
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Contacts
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
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