On January 6, 2023 Nexcella, Inc., a subsidiary of Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us") reported that NXC-201 treatment continues to demonstrate 100% complete responses in a total of 6 relapsed/refractory AL amyloidosis patients (Press release, Immix Biopharma, JAN 6, 2023, View Source [SID1234625967]). Clinical data published December 2022 in Clinical Cancer Research (View Source) demonstrated 100% complete response rate; 100% organ response rate; NXC-201 Duration of Response Not Yet Reached at a median follow-up of 5.2 months (range: 2.5-9.5 months), resulting in a mean 65% reduction (2,656pg/mL) in NT-proBNP from baseline; no grade 4 Cytokine Release Syndrome (CRS); no ICANS neurotoxicity was observed; a 2-stage improvement in NYHA stage was observed. Low-grade CRS duration of median 2 days (range:1-4 days) with median onset on day 2 (range: 1-3 days) points to NXC-201 potentially becoming the first and only out-patient CAR-T to treat AL Amyloidosis and other BCMA-positive malignancies.
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"As we enroll additional patients, we continue to be encouraged by the consistent 100% complete response rate for AL amyloidosis patients treated with NXC-201 to-date," said Gabriel Morris, President, Nexcella, Inc. "We are heartened to provide hope for patients with this devastating disease in our ongoing efforts to bring NXC-201 to market."
Immix Biopharma Subsidiary Nexcella, Inc Announces Additional Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in Relapsed/Refractory AL Amyloidosis Patients, Duration of Response Not Yet Reached
4 patients with relapsed or refractory AL amyloidosis treated with NXC-201 were included in the December 2022 Clinical Cancer Research publication. 4 of 4 patients (100%) experienced a complete response and 4 of 4 patients (100%) experienced an organ response after treatment with NXC-201. 4 of 4 patients (100%) had cardiac involvement at the time of their baseline echocardiogram reading as defined by NT-proBNP levels (>100 pg/ml) (range: 119 – 7,500. Mean 3,100. Median 2,391). Treatment with NXC-201 resulted in a mean 65% (mean 2,656 pg/mL) reduction in mean NT-proBNP from baseline. Additionally, a 2-stage improvement in NYHA stage was observed after treatment with NXC-201.
About NEXICART-1
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI0101), in adults with relapsed or refractory plasma cell dyscrasias, including 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.
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 amyloidosis. The design consists of a structurally differentiated CAR-T, with our proprietary BCMA-targeting CAR, which has demonstrated reduced toxicity in NEXICART-1, supporting investigating NXC-201 as an outpatient therapy.
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.