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Immix Biopharma Subsidiary Nexcella, Inc. Presents 42-Patient Interim Data, with 90% Overall Response Rate in Relapsed or Refractory Multiple Myeloma at NXC-201 Therapeutic Dose from its Phase 1 Expansion Trial at the 5th European CAR T-cell Meeting

Immix Biopharma, Inc.
Immix Biopharma, Inc.
  • The poster presents data for 42 patients with relapsed or refractory multiple myeloma who were treated with NXC-201 (formerly HBI0101), of which 29 received the therapeutic dose of 800 million CAR+T cells as of the data cutoff of October 23, 2022

  • 90% overall response rate (ORR) was observed in 29 multiple myeloma patients receiving the therapeutic dose of NXC-201

  • 17 of 29 (59%) of patients receiving the therapeutic dose reached complete response (CR) or stringent complete response (sCR)

  • Cytokine release syndrome (CRS) was manageable and no neurotoxicity was observed

  • The therapeutic dose of NXC-201 (800 million CAR+T cells) has been established as the recommended Phase 2 dose (RP2D)

  • Data supports investigating NXC-201 as the first potential outpatient CAR-T cell therapy

LOS ANGELES, Feb. 09, 2023 (GLOBE NEWSWIRE) -- 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 and a subsidiary of Immix Biopharma, Inc. (NASDAQ: IMMX), today announced updated clinical data from its ongoing Phase 1 NEXICART-1 (NCT04720313) study of its 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). The dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma and one new evaluable patient in AL (previous clinical data published in Haematologica 2022 and Clinical Cancer Research 2022). The new data are being presented during a poster presentation at the European Society for Blood and Marrow Transplantation and European Hematology Association 5th European CAR T-cell Meeting to be held in Rotterdam, Netherlands February 9-11, 2023.

"I am pleased to present promising NXC-201 efficacy data from our interim Phase 1 dataset, which brings us one step closer to meeting an urgent need for greater access to CAR-T therapies that can considerably shorten treatment waiting time for patients with relapsed or refractory multiple myeloma,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization's Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children and study investigator. “Also encouraging is that we have not yet reached median progression free survival or overall survival, which means that not only could we improve patient outcomes with efficacy, but we may be able to extend lives as well. I look forward to continuing to enroll patients in our ongoing NXC-201 clinical trial.”

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As of the data cutoff of October 23, 2022, 42 multiple myeloma patients were evaluable for efficacy and safety. These patients comprised the dose escalation cohorts for the first dose level (150 million CAR+ T cells, n=6), the second dose level (450 million CAR+T cells, n=7), and a dose expansion cohort at the recommended Phase 2 dose (RP2D) of 800 million CAR+T cells (n=29). This dataset represents 22 new evaluable patients in relapsed or refractory multiple myeloma at the NXC-201 RP2D.

The interim NXC-201 data demonstrate potentially meaningful efficacy and durable responses in relapsed or refractory patients who have a poor prognosis.

  • Of the 42 evaluable patients across all dose levels with median follow-up of 146 days (range, 18-314):

    • 35 of 42 (83%) overall response rate (ORR) was achieved per International Myeloma Working Group criteria

    • 21 of 42 (50%) patients achieved complete response (CR) or a stringent complete response (sCR)

    • 34 of 42 (81%) patients achieved > very good partial response (VGPR)

    • 1 of 42 (2%) patients achieved a partial response (PR)

  • Improved outcomes were observed in the 29 relapsed or refractory multiple myeloma patients receiving the therapeutic dose of NXC-201 (800 million CAR+T cells):

    • 90% ORR was achieved per International Myeloma Working Group criteria

    • 17 of 29 (59%) patients achieved CR or sCR

    • 25 of 29 (86%) patients achieved > VGPR

    • 1 of 29 (4%) patients achieved a PR

  • NXC-201 continues to be well-tolerated. Of the 42 evaluable patients:

    • No cases of immune effector cell-associated neurotoxicity syndrome (ICANs)

    • Low-grade CRS duration of median 2 days (range, 1-7 days) was observed, with the vast majority of CRS events starting on the day of infusion

"We are excited to present 42 patients of NXC-201 clinical trial data in Rotterdam. As of the data cutoff, 29 patients have been treated at our identified recommended phase 2 dose. We plan to continue to enroll additional NXC-201 patients at RP2D in Israel and expand to United States clinical trial sites,” said Gabriel Morris, President of Nexcella.

Ilya Rachman, M.D., Executive Chairman of Nexcella added: “These data continue to highlight meaningful, durable responses with a favorable tolerability profile. We believe NXC-201 could be the world’s first out-patient CAR-T. These results reinforce our plan to advance NXC-201 to BLA submission in 1H 2025.”

The poster can be accessed on the Nexcella corporate website at this link: https://www.nexcella.com/publications/

Poster Presented:

Title: “Point-of-care CART manufacture and delivery: Expanding access to CART therapy via local institutions, Hadassah Medical Center experience”
Event: European Society for Blood and Marrow Transplantation and European Hematology Association 5th European CAR T-cell Meeting
Dates: February 9-11, 2023
Location: Postillion Hotel & Convention Centre WTC Rotterdam, Beursplein 37, 3011 AA Rotterdam, The Netherlands
Times: Thursday, February 9 12:00 - 20:30 CEST / Friday, February 10 08:00 - 18:30 CEST / Saturday, February 11 07:30 - 15:00 CEST

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.

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

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.

Contacts

Stern Investor Relations
Suzanne Messere
Managing Director
Suzanne.Messere@sternir.com
irteam@immixbio.com