Nexcella Announces 2023 Haematologica Editorial Highlighting NXC-201 Efficacy In The Context of U.S. Food And Drug Administration Approved BCMA CAR T Cells

LOS ANGELES, March 31, 2023 (GLOBE NEWSWIRE) — Nexcella, Inc. (“Nexcella”, “Company”, “We” or “Us”) today announced that an editorial written by Maria Sjöstrand and Michel Sadelain of Memorial Sloan Kettering Cancer Center was published 2023 in Haematologica highlighting NXC-201 in the context of the current U.S. Food And Drug Administration (“FDA”) approved BCMA CAR-T Cell therapies.

“The study [of NXC-201] shows a good safety profile, overall similar to other BCMA CAR T cell phase I-II studies, and similar efficacy, albeit with shorter follow-up, to that initially reported with the later FDA-approved BCMA CAR T cells (75% overall response rate [85% ORR in the group given the highest CAR T cell dose] compared with 85% in the phase I trial evaluating ide-cel [marketed as ABECMA® by Bristol Myers Squibb] and 97% in the phase 1b/II trial for cilta-cel [marketed as CARVYKTI® by Janssen/Johnson & Johnson]),” the authors Maria Sjöstrand and Michel Sadelain stated. “[Furthermore, the NXC-201] trial included nine patients who had relapsed after treatment with an anti-BCMA antibody, belantamab mafodotin, prior to receiving HBI0101, which the authors suggested may be associated with a less favorable response to CAR therapy.”

The title of the editorial is “Driving CARs to new places: locally produced BCMA CAR T cells to treat multiple myeloma,” published in Haematologica Early View, available at www.nexcella.com/publications.

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. 

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, 5^th 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 5^th 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 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 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 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 58 patients treated as of March 23, 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.

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