- 95% overall response rate observed in relapsed/refractory multiple myeloma patients not previously treated with BCMA-targeted therapy
- 98% overall response rate observed in relapsed/refractory multiple myeloma patients without extra-medullary disease
- Updated results will be communicated at the presentation time December 11, 2023
LOS ANGELES, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, today announced that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 65th American Society of Hematology (ASH) Annual Meeting to be held in San Diego, California, December 9-12, 2023.
“75% of patients on multiple myeloma CAR-T waiting lists at U.S. hospitals do not receive the CAR-T therapy. As CAR-Ts are expected to be approved for earlier lines of treatment, we believe demand is likely to increase,” said Ilya Rachman, MD PhD, Chief Executive Officer of Immix Biopharma. “We are working tirelessly to make NXC-201 an option for these patients waiting for multiple myeloma CAR-Ts.”
“Today, only 5% of U.S. hospitals offer multiple myeloma CAR-Ts due to toxicities,” said Gabriel Morris, Chief Financial Officer of Immix Biopharma. “Our N-GENIUS technology platform, which we believe overcomes neurotoxicity, aims to allow the remaining 95% of U.S. hospitals, including community hospitals, to offer our CAR-T NXC-201.”
ASH Presentation Details (NXC-201 Multiple Myeloma):
|65th ASH Annual Meeting and Exposition, San Diego, CA
|“Safety and Efficacy of a Locally Produced Novel Anti-BCMA Chimeric Antigen Receptor T-Cell (CART) (HBI0101) for the Treatment of Relapsed and Refractory Multiple Myeloma”
Date/Time (Pacific Time)
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 and relapsed/refractory multiple myeloma.
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 was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 in relapsed/refractory Multiple Myeloma according to the International Myeloma Working Group (IMWG) Uniform Response Criteria and in relapsed/refractory AL Amyloidosis 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. ImmixBio plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis in order to expand the ongoing clinical trial to the U.S. The expected primary endpoint for the Phase 2 portion of the ongoing Phase 1b/2a clinical trial of NXC-201 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. 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.
About Multiple Myeloma
Multiple myeloma (“MM”) is an incurable blood cancer of plasma cells that starts in the bone marrow and is characterized by an excessive proliferation of these cells. Despite initial remission, unfortunately, most patients are likely to relapse. There are 35,730 patients in the United States diagnosed with MM each year. Prognosis for patients who do not respond to or relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents remains poor. The $13.9 billion Multiple Myeloma market in 2017 is expected to reach $28.7 billion in 2027 according to Wilcock, et al. Nature Reviews.
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 CAR-T NXC-201 for relapsed/refractory AL Amyloidosis and relapsed/refractory multiple myeloma, for which we have observed overall response rates of 100% and 95%, respectively, in the ongoing Phase 1b/2a NEXICART-1 (NCT04720313) clinical trial (July 17, 2023). NXC-201 has the potential to be the world’s first out-patient CAR-T. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both AL Amyloidosis and multiple myeloma. Our lead tissue specific therapeutic (TSTx) asset IMX-110, currently in Phase 1b/2a clinical trials as a monotherapy and IMMINENT-01 combination clinical trial with BeiGene’s anti-PD-1 antibody tislelizumab in relapsed/refractory solid tumors, holds Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA. Learn more at www.immixbio.com.
About Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq:IMMX), is a Los Angeles, California based clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications. Our lead candidate, next generation BCMA-targeted CAR-T NXC-201 for relapsed/refractory AL amyloidosis and relapsed/refractory multiple myeloma, has produced 100% and 95% response rates in each indication, respectively, as of July 17, 2023 across 72 patients. NXC-201 has been awarded Orphan Drug Designation (ODD) by the FDA in both multiple myeloma and AL Amyloidosis. We believe NXC-201 has potential to be the world’s first outpatient CAR-T. Our N-GENIUS platform allows us to discover, develop, and manufacture cutting-edge cell therapies for patients in need. To learn more about Nexcella, Inc. visit us at www.nexcella.com
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