Immix Biopharma Announces Additional NXC-201 AL Amyloidosis Clinical Data Accepted for Oral Presentation at the 20th International Myeloma Society Annual Meeting (September 27-30, Athens Greece)
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LOS ANGELES, Aug. 16, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced that additional NXC-201 clinical data for relapsed/refractory AL Amyloidosis has been selected for oral presentation at the 20th International Myeloma Society Annual Meeting to be held in Athens, Greece, September 27-30, 2023.
“We are pleased to present additional clinical data in the NEXICART-1 clinical study evaluating NXC-201 in patients with relapsed/refractory light chain AL amyloidosis at the upcoming International Myeloma Society Annual Meeting in September,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator. “We continue to make progress in this important indication, in the hope of providing patients with new treatment options.”
Poster Presentation Details:
| Event | 20th International Myeloma Society Annual Meeting, Athens, Greece |
| 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 (EEST) |
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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 or refractory multiple myeloma and AL amyloidosis.
About NEXICART-1
NEXICART-1 (NCT04720313) is 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 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma (R/R MM) patients, according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis (R/R ALA) according to consensus recommendations.
The Phase 1b portion of the ongoing Phase 1b/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Nexcella plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in R/R MM and R/R ALA in order to expand the ongoing clinical trial to the U.S.
The expected primary endpoint for the Phase 2 portion of the ongoing trial in R/R MM is overall response rate and duration of response. Nexcella plans to submit data to the FDA once 100 patients have been treated. The expected primary endpoint for NXC-201 in R/R ALA is overall response rate. Nexcella plans to submit data to the FDA once 30-40 patients have been treated.
About AL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by these cells cause a buildup of misfolded immunoglobulin proteins in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
AL amyloidosis affects roughly 30,000 – 40,000 patients in the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases annually in the U.S. The estimated annual global incidence ~15,000 patients.
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. Our lead CAR-T cell therapy asset, NXC-201, is being developed for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma. Initial response rates of
About Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq:IMMX), is a clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our lead candidate, a next generation BCMA-targeted CAR-T NXC-201 for multiple myeloma and AL amyloidosis, has produced
Forward Looking Statements
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Investor Contact
Mike Moyer
LifeSci Advisors
mmoyer@lifesciadvisors.com
Company Contact
irteam@immixbio.com
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