Updated clinical data from NXC-201, a next-generation CAR-T for multiple myeloma and AL amyloidosis, will be presented February 9-11, 2023 in Rotterdam, The Netherlands.
LOS ANGELES, CALIFORNIA, December 28, 2022 (GLOBE NEWSWIRE) — Nexera Co., Ltd. (“Nexcella”, “Company”, “we” or “our”), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, today updated NXC -201 selected clinical data announced to be presented at upcoming European Society of Blood and Bone Marrow Transplantation and European Hematology Congress 5th Annual European CAR T Cell Congress, February 9-11, 2023 in Rotterdam, Netherlands.
Polina Stepensky, MD, director of the Hadassah Medical Organization’s bone division, said: Bone marrow transplantation and immunotherapy for adults and children, and principal investigator. “As we continue to accumulate clinical data, we are learning more about this therapy’s potential to treat multiple myeloma and AL amyloidosis.”
Poster to be announced:
- “Manufacturing and Delivery of Point-of-Care CARTs for the Treatment of Multiple Myeloma and AL Amyloidosis: The Hadassah Medical Center Experience”
Nexcella, Inc. previously reported that NXC-201 (formerly HBI0101) had an 85% overall response rate (ORR) and 71% complete response/stringency at therapeutic doses from the first 20 patients in the ongoing phase announced that it produced a complete response (CR/sCR). 1b/2a Relapsed/refractory multiple myeloma ongoing clinical trial with a median data cutoff of 6 (range, 3-13) prior lines as of 27 June 2022. increase. NXC-201 also produced a 100% His ORR and a 100% organ response rate in 4 relapsed/refractory AL amyloidosis patients as of the publication date of the AL amyloidosis manuscript of 26 February 2022. Additionally, there were zero neurotoxicities of any grade and zero events of immune effector cell-associated neurotoxic syndrome (ICAN) with NXC-201 treatment. These data are Hematology https://doi.org/10.3324/haematol.2022.281628 (multiple myeloma) and clinical cancer researchhttps://doi.org/10.1158/1078-0432.CCR-22-0637 (AL amyloidosis).
A median duration of CRS of 2 days with a median onset of 1 day (range, 1–5 days) after dosing at therapeutic doses in low-grade (Grade 1/2) relapsed/refractory multiple myeloma was NXC-201 is potentially the first and only exogenous CAR-T for multiple myeloma, AL amyloidosis, and other BCMA-positive malignancies.
NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2 open-label study investigating the safety and efficacy of NXC-201 (formerly HBI0101) in adults with relapsed or refractory multiple myeloma. I am evaluating. All exams are as of June 27, 2022. It was triple-class refractory (to at least 1 immunomodulatory agent, 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 maximum 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 according to the International Myeloma Working Group (IMWG) Uniform Response Criteria, evaluating overall survival, progression-free survival and response rate .
NXC-201 (formerly HBI0101) is an investigational chimeric antigen receptor targeting BCMA being investigated in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and amyloidosis T (CAR-T) cell therapy. This design consists of a structurally differentiated CAR-T and our proprietary His BCMA-targeted CAR, which has demonstrated reduced toxicity with NEXICART-1, and is expected to provide NXC as an outpatient treatment. -201 survey support.
About multiple myeloma
Multiple myeloma (“MM”) is an incurable blood cancer of plasma cells that begins in the bone marrow and is characterized by excessive proliferation of these cells. Despite initial remissions, unfortunately most patients are likely to relapse. In the United States, 34,470 patients are diagnosed with MM each year. The prognosis remains poor for patients who do not respond to standard treatments, such as protease inhibitors and immunomodulatory agents, or who relapse after treatment.
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 enables us to discover, develop and manufacture cutting-edge cell therapies for patients in need. For more information about Nexcella, Inc., please visit www.nexcella.com. www.nexcella.com.
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