LOS ANGELES, May 04, 2023 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio”, “Company”, “We” or “Us”) today announced that updated NXC-201 clinical data has been selected for presentation at the upcoming 26th Annual Meeting of The American Society of Gene & Cell Therapy (ASGCT) to be held in Los Angeles May 16-20, 2023.
“We are delighted to present additional clinical data for what we believe is the only CAR-T in development in AL Amyloidosis at the upcoming 26th Annual Meeting of The American Society of Gene & Cell Therapy,” 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 for the NEXICART-1 Phase 1b/2a clinical trial of NXC-201. “A potential one-time treatment such as CAR-T NXC-201 in AL amyloidosis would be a welcome option for this devastating disease.”
Title: “BCMA-Targeted CART (HBI0101), a Safe and Efficacious Novel Modality of Treatment for Light Chain Amyloidosis Patients”
Oral Presentation Date/Time: Friday May 19, 2023, 9:15am - 9:30am
Event: 26th Annual Meeting of The American Society of Gene and Cell Therapy, Los Angeles, CA
Session Title: Late-Breaking Abstracts 1
Session Date/Time: Friday May 19, 2023, 8:00am - 9:45am
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 or refractory multiple myeloma and AL amyloidosis.
The primary objective of the Phase 1b portion of the study is to characterize the safety and confirm the Maximally Tolerated Dose (MTD) and Phase 2 dose of NXC-201. The Phase 2 portion of the study will evaluate the efficacy and safety of NXC-201 with endpoints of overall survival, progression-free survival and response rates according to International Myeloma Working Group (IMWG) Uniform Response Criteria.
The Phase 1b portion of the ongoing Phase 1b/2 clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Over the coming months, Nexcella (an Immix Biopharma subsidiary) plans to submit an IND application to the FDA for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and 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. Nexcella plans to submit data to the FDA in 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. Nexcella plans to submit data to the FDA in AL amyloidosis once 30-40 patients are treated with 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 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 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 plasma cells cause buildup 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 total throughout the U.S. and Europe, and it is estimated that there are approximately 3,000 – 4,000 new cases of AL amyloidosis annually in the U.S. The annual global incidence of AL Amyloidosis is ~15,000 patients.
The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBioTM) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases. Our lead asset is IMX-110, currently in Phase 1b/2a clinical trials as a monotherapy and in its IMMINENT-01 combination clinical trial with BeiGene/Novartis’ anti-PD-1, tisleilizumab, for which patient dosing begin in Feb 2023. IMX-110 holds orphan drug designation (ODD) by the FDA for soft tissue sarcoma, and has received Rare Pediatric Disease Designation (RPDD) by the FDA the treatment of rhabdomyosarcoma, a life-threatening form of cancer in children. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. Additionally, ImmixBio owns 98% of Nexcella, Inc, developing CAR-T NXC-201 for multiple myeloma and AL amyloidosis, with 92% and 100% response rates in each indication, respectively, as of February 9, 2023. Learn more at www.immixbio.com.
About Nexcella, Inc.
Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX), is a Los Angeles, CA 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 multiple myeloma and AL amyloidosis has produced 92% and 100% response rates in each indication, respectively, as of February 9, 2023 across 58 patients. 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.
Forward Looking Statements
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