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

• 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, 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 5^th 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.”

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.

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Contacts:
Stern Investor Relations
Suzanne Messere
Managing Director
Suzanne.Messere@sternir.com 
irteam@nexcella.com