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U.S. engineering batches support planned expansion of its ongoing NEXICART-1 (NCT04720313) NXC-201 CAR-T clinical trial to the United States Engineering batches are the first step in transferring the Company's existing CAR-T GMP manufacturing process to the United States Commencement of U.S. engineering batches follows selection of U.S. GMP manufacturer in February 2023
LOS ANGELES, May 26, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”,“Company”,“We” or“Us”), today announced the commencement of CAR-T NXC-201 Engineering Batches at its U.S. Manufacturing Site. These U.S. engineering batches will support the planned U.S. expansion of the Company's ongoing Phase 1b/2a NEXICART-1 (NCT04720313) study of its novel BCMA-targeted chimeric antigen receptor T (car-T) cell therapy NXC-201. This manufacturing milestone represents a crucial next step in transferring the Company's existing CAR-T GMP manufacturing process to the United States following the selection of a U.S. GMP manufacturer in February 2023.
“We are working tirelessly to bring NXC-201 to U.S. patients,” said Ilya Rachman, M.D. PhD Executive Chairman of Nexcella.“NXC-201 is the first CAR-T being developed in AL Amyloidosis, and in Multiple Myeloma, patients face significant obstacles when seeking BCMA-targeted CAR-T treatments like NXC-201. We look forward to continuing to advance NXC-201 as we work to improve treatment outcomes for patients in the U.S. suffering from AL amyloidosis and multiple myeloma.”
“Today, 95% of U.S. medical centers are unable to offer CAR-T cell therapy,” said Gabriel Morris, President of Nexcella.“NXC-201 has already been trialed in over 50 patients, demonstrating a 1-2 day median short side-effect duration, which offers potential to become the first out-patient CAR-T, potentially reducing hospitalization costs up to 80% and enabling dosing in 95% of U.S. medical centers today unable to offer CAR-T cell therapy.”
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 across 58 patients.
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 was to characterize the safety and confirm the recommended Phase 2 dose (RP2D) 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/2a clinical trial has been successful in determining the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells. Over the coming months, Nexcella 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.
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 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 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 .
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, 2022, 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.
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