Nexcella Announces New Positive NXC-201 Clinical Data Demonstrating 100% Complete Responses in AL Amyloidosis Patients + Additional Positive Multiple Myeloma Safety Data Demonstrating NXC-201 Outpatient CAR-T Treatment Potential
LOS ANGELES, March 23, 2023 (GLOBE NEWSWIRE) — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced that NXC-201 treatment continues to demonstrate 100% complete hematologic responses and 100% organ response rate – cardiac, renal, liver response – in a total of 8 AL amyloidosis patients (an additional 2 patients maintaining 100% complete response). Additionally, Nexcella announced new positive safety data in relapsed/refractory multiple myeloma demonstrating outpatient CAR-T treatment potential.
To date, 58 patients have been treated with NXC-201, 50 in multiple myeloma, and 8 in AL amyloidosis.
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. The Amyloidosis market was $3.6 billion in 2017, expected to reach $6 billion in 2025, according to Grand View Research.
“We’re extremely excited with the results we’re seeing. We are making significant advancements with NXC-201 against the backdrop of the current standard of care in these large markets,” said Gabriel Morris, President, Nexcella, Inc.
“In Multiple Myeloma, our 90% overall response rate continues to attract the attention of key opinion leaders globally. We have accumulated clinical data from 50 patients and counting,” said Ilya Rachman, MD, PhD, Executive Chairman, Nexcella, Inc. “In AL Amyloidosis, our 100% complete response rate with 100% organ responses across cardiac, renal and liver organ systems fuels our continued excitement. NXC-201’s positive safety profile to-date could enable outpatient treatment in the thousands of U.S. community hospitals who today are unable to dose CAR-Ts.”
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 AL 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.
As of the October 23, 2022 data cutoff, updated clinical data in 47 patients from the ongoing Phase 1b/2a portion of the NEXICART-1 (NCT04720313) study of the novel, autologous, BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 for the treatment of relapsed or refractory multiple myeloma and light chain amyloidosis (AL) showed:
- Multiple Myeloma – 90% overall response rate (59% complete responses) for NXC-201 at the therapeutic dose in an ongoing 42-Patient Phase 1 expansion trial (Haematologica https://doi.org/10.3324/haematol.2022.281628, 5th European CAR-T cell meeting https://www.nexcella.com/publications/) in relapsed/refractory multiple myeloma. All patients treated with NXC-201 were triple-class refractory (to at least 1 immunomodulatory drug, 1 proteasome inhibitor and 1 anti-CD38 antibody).
- Additional data in 2023 demonstrated outpatient CAR-T treatment potential: cytokine release syndrome (CRS) median onset day zero; median CRS duration 1 day; no grade 4 CRS; only 1 grade 3 CRS across 42 relapsed/refractory multiple myeloma patients.
- The expected primary endpoint for a pivotal study of NXC-201 in relapsed/refractory multiple myeloma is overall response rate.
- AL Amyloidosis – 100% organ response rate (cardiac, renal, liver), 100% complete hematologic responses (MRD negativity 10-5), for NXC-201 in 8 relapsed/refractory AL Amyloidosis patients, of which the initial cohort was presented at the 5th European CAR-T cell meeting https://www.nexcella.com/publications/, and published in Clinical Cancer Research https://doi.org/10.1158/1078-0432.CCR-22-0637.
- The expected primary endpoint for a pivotal study of NXC-201 in relapsed/refractory AL Amyloidosis is overall response rate.
- The expected therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D) for both multiple myeloma and AL amyloidosis.
Additional information on NXC-201 multiple myeloma clinical data as of October 23, 2022 is available here.
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 multiple myeloma and AL amyloidosis. The Phase 1b portion of the study has already established an expected recommended Phase 2 dose (RP2D) of 800 million CAR+T cells.
The expected primary endpoint for a pivotal study of NXC-201 will be overall response rate in multiple myeloma, and overall response rate in AL amyloidosis.
To date, 58 patients have been treated with NXC-201, 50 in multiple myeloma, and 8 in AL amyloidosis.
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 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. 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 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 lead candidate, CAR-T NXC-201, is currently in Phase 1b/2 clinical trials for relapsed/refractory multiple myeloma and AL amyloidosis, with 50 patients treated as of Feb 27, 2023. 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
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Immix Biopharma’s Annual Report on Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Immix Biopharma, Inc. specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements.
Investor Contact
Suzanne Messere
Stern Investor Relations
Suzanne.Messere@sternir.com
Company Contact
irteam@nexcella.com
