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Immix Biopharma Subsidiary Nexcella Enters into U.S. GMP Manufacturing Agreement to Expand Ongoing NXC-201 Phase 1b/2 Clinical Trial to the U.S.

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  • Nexcella, Inc. initiates process of bringing NXC-201 to the United States by entering into an agreement with a well-known GMP cell therapy manufacturer that will supply Phase 1b/2 NXC-201 clinical trial material
  • NXC-201 is in development for the treatment of patients with relapsed or refractory multiple myeloma and light chain (AL) amyloidosis
  • Nexcella believes recently reported Phase 1b data from the ongoing Phase 1b/2 clinical trial supports investigating NXC-201 as the first potential outpatient CAR-T cell therapy

LOS ANGELES, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Nexcella, Inc. (“Nexcella”, “Company”), a biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), today announced that it has entered into a manufacturing agreement with a well-known United States Good Manufacturing Practice (GMP) cell therapy manufacturer that will supply a US Phase 1b/2 clinical trial of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. As Nexcella plans to expand the ongoing Israel trial to the U.S., it is necessary to demonstrate that clinical trial drug supply has been secured when submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). This U.S. manufacturing site is expected to supply NXC-201 material for the Phase 1b/2 clinical trial in the U.S. following an IND submission to the FDA and approval. 

Over the coming months, Nexcella plans to initiate a pre-IND meeting with the FDA, submit an IND application to the FDA, and obtain IND approval for a Phase 1b/2 of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. We believe recently reported Phase 1b clinical data from the ongoing clinical trial in Israel supports expanding the NXC-201 trial to the U.S.

As of the October 23, 2022 data cutoff, updated clinical data from the ongoing Phase 1b 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 patients with 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)
  • AL Amyloidosis – 100% organ response rate, 100% complete responses (MRD negativity 10-5), published for NXC-201 in 5 relapsed/refractory patients (Clinical Cancer Research  https://doi.org/10.1158/1078-0432.CCR-22-0637, 5th European CAR-T cell meeting https://www.nexcella.com/publications/)
  • The therapeutic dose of NXC-201 (800 million CAR+T cells) has already been established as the recommended Phase 2 dose (RP2D)

Additional information on NXC-201 clinical data as of October 23, 2022 is available here.

“We are excited about our progress toward bringing NXC-201 to United States clinical sites. Securing clinical supply is a critical step in advancing NXC-201 toward a potential U.S. regulatory submission. We believe NXC-201 could become a best-in-class therapy for patients suffering from AL amyloidosis and multiple myeloma,” said Gabriel Morris, President of Nexcella. 

Ilya Rachman, M.D., Executive Chairman of Nexcella added: “NXC-201 has a highly-differentiated, mild tolerability profile. We believe NXC-201 could be the world’s first outpatient CAR-T. We look forward to working with our partners at our new U.S. manufacturing site as we further our plans to bring NXC-201 to U.S. patients who need alternative treatments.”

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, all of which as of October 23, 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.

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.

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.

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, Inc.
Suzanne.Messere@sternir.com 


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