On November 6, 2023 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, reported that updated NXC-201 relapsed/refractory multiple myeloma clinical data has been selected for presentation at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held in San Diego, California, December 9-12, 2023 (Press release, Immix Biopharma, NOV 6, 2023, View Source [SID1234637028]).
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"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):
Event 65th ASH (Free ASH Whitepaper) Annual Meeting and Exposition, San Diego, CA
Title "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"
Presentation
Date/Time (Pacific Time)
Publication #4852
Session Date: Monday, December 11, 2023
Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III
Session Time: 6:00 PM – 8:00 PM
Presentation Time: San Diego Convention Center, Halls G-H
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 and relapsed/refractory 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 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.