Nexcella, Inc. in-licenses NXC-201, BCMA-targeted Next-Generation CAR-T Therapy Demonstrating High Complete Response Rate in Heavily Pre-Treated Multiple Myeloma (71% Complete Responses) and AL Amyloidosis (100% Complete Responses)
- Category: DNA RNA and Cells
- Published on Thursday, 15 December 2022 17:34
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- Multiple Myeloma - 85% overall response rate (71% CR/sCR) for NXC-201 at therapeutic dose in an ongoing Phase 1b study in 20 relapsed/refractory patients as of June 27, 2022 data cutoff (Haematologica https://doi.org/10.3324/haematol.2022.281628)
- AL Amyloidosis - 100% complete responses, 100% organ response rate for NXC-201 in 4 relapsed/refractory patients (Clinical Cancer Research https://doi.org/10.1158/1078-0432.CCR-22-0637)
- Potential first and only out-patient CAR-T: Low-grade CRS duration of median 2 days (range, 1-5 days) at NXC-201 therapeutic dose
- Nexcella, Inc is a wholly owned subsidiary of Immix Biopharma (NASDAQ:IMMX) formed to develop NXC-201 and other CAR-T cell therapies for oncology and other diseases
LOS ANGELES, CA, USA I December 14, 2022 I Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today announced that it has in-licensed BCMA-targeted next-generation CAR-T therapy NXC-201 (formerly HBI0101) with 85% overall response rate (ORR) and 71% complete response/stringent complete response (CR/sCR) at the therapeutic dose from the first 20 patients in an ongoing phase 1b relapsed/refractory multiple myeloma ongoing clinical trial as of June 27, 2022 data cutoff with a median of 6 (range, 3-13) prior lines of therapy. NXC-201 also produced 100% ORR and 100% organ response rate in 4 relapsed/refractory AL Amyloidosis patients. In addition, zero neurotoxicity of any grade was observed and zero events of immune effector cell-associated neurotoxicity syndrome (ICANs) were observed with NXC-201 treatment as of the June 27, 2022 data cutoff. These data were published in Haematologica https://doi.org/10.3324/haematol.2022.281628 (multiple myeloma) and Clinical Cancer Research https://doi.org/10.1158/1078-0432.CCR-22-0637 (AL amyloidosis). Immix Biopharma has formed a wholly-owned subsidiary, Nexcella, Inc., to develop and potentially commercialize NXC-201.
Low-grade (grade 1/2) CRS duration of median 2 days with median onset of 1-day post-dosing (range, 1-5 days) at therapeutic dose in relapsed/refractory multiple myeloma points to NXC-201 potentially becoming the first and only out-patient CAR-T for Multiple Myeloma, AL Amyloidosis and other BCMA-positive malignancies. The formation of Nexcella, Inc is expected to have a minimal impact on Immix Biopharma’s financial position, as Nexcella, Inc is expected to be an independently financed company.
ThinkEquity LLC acted as advisor to Immix Biopharma in this transaction.
“We are thrilled to share that we have secured exclusive rights to NXC-201, a next generation BCMA CAR-T therapy whose 85% ORR and 71% CR rate in heavily pretreated multiple myeloma patients in the ongoing Phase 1 trial are compelling,” said Ilya Rachman, MD PhD, Executive Chairman of Nexcella. “Additionally, encouraged by the 100% complete response rate and 100% organ response rate in AL Amyloidosis, we are planning to enroll additional patients to validate these findings.”
“Considering its short 2-day median CRS duration, occurring within a median 1-day post-dosing, we look forward to exploring outpatient administration of NXC-201,” added Gabriel Morris, President of Nexcella.
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2, open-label study evaluating the safety and efficacy of NXC-201 (formerly HBI10101), in adults with relapsed or refractory multiple myeloma, all of which as of June 27, 2022 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody).
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.
NXC-201 (formerly HBI10101) 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 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 34,470 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.
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 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.
About Immix Biopharma, Inc.
Immix Biopharma, Inc. (ImmixBio™) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company pioneering a novel class of Tissue-Specific Therapeutics (TSTx)™ targeting oncology and immuno-dysregulated diseases. Our proprietary SMARxT Tissue-Specific™ Platform produces drug candidates that circulate in the bloodstream, exit through tumor blood vessels and simultaneously attack all 3 components of the tumor micro-environment (TME). We believe ImmixBio’s TME Normalization™ technology severs the lifelines between the tumor and its metabolic and structural support. Learn more at www.immixbio.com